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Rare But Real: How One Startup Is Willing Itself To Lift China Orphan Drug Market

by brian.yang@informa.com

Executive Summary

Today medical sciences have developed several options learningworksca.org cheapest cialis which would help men in getting rid of their sexual health and the factors which might be responsible for erectile dysfunction. One just needs to order the drug via ecommerce shop. get viagra overnight He was a committed runner, and when stomach pain persisted he buy cialis canada simply ran harder. Besides that, the temperature of testis cannot be adjusted normally as viagra pills uk scrotum is surrounded by compression, so that the temperature must be 15 to 30 degree c. As a promising market for orphan drugs, China has seen several approvals in this space in the past six months,
mostly from multinationals. But Beijing-based CANbridge believes that a smaller biotech also has a good shot at a leadership role, despite a lack of funding and reimbursement and prickly pricing issues.

Click here to read the full story

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It’s breathtaking’: A Chinese biotech CEO weighs in on policy changes remaking China’s FDA

STAT

Biotech

It’s breathtaking’: A Chinese biotech CEO weighs in on policy changes remaking China’s FDA

By Rebecca Robbins @rebeccadrobbins

https://www.statnews.com/2018/02/22/james-xue-biotech-ceo-china-fda/

February 22, 2018

With China’s biotech sector on the rise, changes are afoot at the agency tasked with regulating the country’s pipeline of new drugs.

In recent months, China’s version of the U.S. Food and Drug Administration, known as CFDA, has introduced a host of new regulations meant to make drug makers happy: Companies can now submit certain datafrom clinical trial sites outside of China. More Chinese hospitals can run trials. Manufacturing need no longer be done in-house. And drug makers weary of waiting for a green light to proceed with a safety study could soon be allowed to go ahead if they don’t hear back from the agency within 60 days.

James Xue, CEO of Beijing-based CANbridge Life Sciences, has had a front-row view of it all. He’s been interacting with CFDA officials on and off for the past 15 years, first in running Genzyme’s China operations and now in steering his own biotech company seeking approval for four oncology drugs. And Xue knows how drug approval works in the U.S., too: Born and raised in China, Xue did his graduate education and started his biopharma career in the U.S. before coming home as part of Thousand Talents, a Chinese government recruitment program that’s seen both successes and struggles.

So what does the raft of changes at the CFDA look like to such a tuned-in observer? We called up Xue to get his impressions.

What do you make of all these changes at the CFDA?

“In the last 12 months, I have experienced more reform and drastic change for better [than] over the 14 years before that combined,” Xue said. “It’s breathtaking, in a very good, very positive way.”

James Xue, CEO of CANbridge Life Sciences CANbridge Life Sciences

The palpable change, he says, extends to how quickly CFDA officials respond in correspondence about his company’s applications — a change he attributes to the agency’s moves to cut the backlog of applications for old generic products.

What’s the biggest difference between working with China’s FDA and the U.S. FDA?

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“The biggest difference prior to the reforms last year was the mentality,” Xue said. The CFDA was “not really risk taking at all.”

But the recent changes at the CFDA are making it not so different to work with drug regulators in China compared to those in the U.S., Xue said.

How have changes at the CFDA shaped your strategy at CANbridge?

Of the four drugs CANbridge is trying to get approved in China, two have already been approved in other countries. For the other two molecules, Xue is going to China for first-time approval.

Now that his team can submit data from clinical trial sites outside of China, Xue is taking a second look at the data from global clinical trials supporting several of the molecules his company has licensed to try to commericalize in China. “Before, we had to reproduce those data,” he said.

That same change has Xue thinking more about future hiring plans in North America. And another recent policy change allowed him to open a clinical trial site in Taiwan in pursuit of an approval in China.

Have any of the recent changes at the CFDA made it harder for you to do business or move your products along swiftly?

Xue pointed to a new CFDA policy that allows drug makers to contract out their manufacturing to a plant in China, instead of having to set up a plant in-house. That’s a “very positive” change, Xue said, but it doesn’t go far enough. He’d like to see it extend to manufacturing plants outside of China.

“I wish the CFDA would be more bold in allowing ex-China manufactured product to be entitled to the same benefits of the reform,” Xue said. That way, “we would not need to duplicate efforts by transporting a manufacturing process that is already very matured and established in the West for the sake of bypassing this laborious process.”

What challenges remain in working with the CFDA?

“I think the biggest pain point is still the truly innovative drug categories,” Xue said. When it comes to cutting-edge science, “the Chinese FDA is still not yet experienced enough to review the protocol or to give constructive input in making the protocol less risky” and more likely to get approved.

When you talk with U.S. biotech CEOs, how aware are they of all these changes at China’s FDA?

“I’m surprised, actually,” Xue said. “Their senior executives are very tuned in to the recent reforms in China. I have no doubt that they affect how they do their corporate strategy on a global basis. Nobody can afford to deprioritize China’s rise.”

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China’s Canbridge nabs Puma’s Nerlynx for HER2+ breast cancer in $70M deal

The news source of record covering the development of innovative human therapies

Actionable Intelligence • Incisive Analysis
February 7, 2018 Volume 29, No. 26
http://www.bioworld.com/content/chinas-canbridge-nabs-pumas-nerlynx-her2-breast-cancer-70m-deal-0

China’s Canbridge nabs Puma’s Nerlynx for HER2+ breast cancer in $70M deal

By Shannon Ellis, Staff Writer

SHANGHAI – Beijing’s Canbridge Life Sciences Inc. has acquired the greater China rights to Puma Biotechnology Inc.’s Nerlynx (neratinib) as an adjuvant for early stage HER2-positive breast cancer and other HER2 tumors, such as gastric cancer, which is highly prevalent in China.

The deal will provide Puma with an up-front payment of $30 million, with the possibility of another $40 million upon regulatory milestones. Royalties and sales milestones could also provide Puma with further payments.

Nerlynx, an irreversible tyrosine kinase inhibitor, was approved by the U.S. FDA in July. But the Los Angeles-based company encountered pushback from Europe’s regulators, with the Committee for Medicinal Products for Human Use (CHMP) indicating a negative trend vote last month. (See BioWorld, July 19, 2017, and Jan. 25, 2018.)

With poor prospects in Europe, Canbridge remains steadfast about Nerlynx’s chances in greater China. “We assessed the opportunity and even with the recent news from Europe, we will not waver in terms of our position to get this product to patients in China,” James Xue, Canbridge chairman, CEO and president, told BioWorld. “I want to emphasize this is a brand new drug that received U.S. FDA approval in an area that has very little treatment options and has a strong case for us to present to the authorities in our geographies, including mainland China, Taiwan, Hong Kong and Macau.”

Nerlynx is approved in the U.S. as an adjuvant for patients using Herceptin (trastuzumab, Roche Holding AG)-based therapy with HER2-positive breast cancer. About 20 percent to 25 percent of breast cancer patients overexpress the HER2 protein.

After a course of Herceptin, patients often have no additional treatment options, explained Xue. Depending on the individual, within about five years a significant number of patients – up to 25 percent – will find the cancer recurs in a very vicious form. Many patients lacking treatment options will die within six months; Xue called it “a very dire situation.” In China, that is especially so. “In terms of Chinese patients, the Chinese breast cancers are more aggressive compared to the western form and occur in a younger age group relative to the western patient population,” said Xue.

Assessing the global phase III MRCT data from Puma, Xue said a significant number of patients taking Nerlynx had reduced rates of recurring cancer vs. the comparator (according to Puma’s release it can be 34 percent). “This is a major accomplishment and clinical benefit for patients who do not have recurring cancer; they will live over five years,” Xue said. “And for those with recurring cancer, it allows those patients to have a chance at extended disease-free survival.”
Accelerated approval in China possible
This enhanced blood flow effects of viagra more info here results in healthy, long and thick erections. Sildenafil may be brought with or without nourishment, yet bringing it with a high-fat supper may build the time before buy viagra without prescription the solution begins working. The amalgamation of this generic medicine and the sexual organ. tadalafil vs cialis Oil massaging of genital organ helps in dilating blood vessels and improving the circulation of blood. viagra for sale The large amount of data that Puma collected in its global pivotal study may help Canbridge seek accelerated approval in China. Post-ICH (International Council for Harmonisation) admittance, China’s regulators have said they will accept global data. Since a portion of the data collected by Puma also included Chinese patients and those of Asian ethnicity, there is a chance that Canbridge may be able to seek approval without a clinical study in China, or only a limited one.

“We believe that we will be able to leverage the existing data to a maximum extent for a shortened market approval pathway,” said Xue. “We will leverage the data that Puma has already built on a global scale, including Asian patients with their pivotal study. Over 2,000 patients enrolled in the pivotal study over five years – it is one of the most sophisticated studies ever done in breast cancer.”

But in Europe, regulators have raised concerns over the clinical relevance and risk-worthiness of Nerlynx in extended adjuvant use for women with early stage, HER2-positive breast cancer and asked for Puma to take “additional steps.”

Puma said the CHMP found a benefit-risk assessment for Nerlynx to be negative since it was based solely on evidence from a single pivotal trial and because “two- and five-year invasive disease-free survival benefits observed to date may lack sufficient clinical relevance.”

Another factor Canbridge will need to work through when discussing Nerlynx with Asian regulators are the side effects of Nerlynx, including grade III diarrhea. “Puma did a good job to educate us about how they developed effective patient management protocol for the side effects,” Xue said. “We looked at the data for the prevalence and seriousness of the diarrhea … the protocol developed by Puma should be very straightforward for us to adopt in China.”

Meanwhile, in the U.S., Puma is seeking to widen the scope of use for Nerlynx to more HER2-expressed cancers in a basket trial for patients with breast, cervical, biliary, salivary and non-small-cell lung cancers.

Canbridge will take the lead on gastric cancer, which is highly prevalent in China. The company will also seek out approval for other forms of HER2-positive cancers as well, including late-stage metastatic breast cancer in China.

Getting market ready
With many of China’s regulatory hurdles now lowered, Canbridge, like many Chinese biotech startups, is getting market ready for the first time. The firm’s plan is to see Nerlynx on the market by mid-2019. In advance of that, Canbridge’s CAN-002 for mucositis caused by radiation or high-dose chemotherapy should receive CFDA approval.

“The timing of this deal is excellent in terms of building a full-fledged commercial presence which is already underway,” said Xue. “This is transformative because it accelerates our vision to build a virtually integrated company from development to full commercialization. My team and I are very excited about Puma’s decision to choose us as a partner. We want to be

“I want to emphasize this is a brand new drug that received U.S. FDA approval in an area that has very little treatment options and has a strong case for us to present to the au¬thorities in our geographies, including main¬land China, Taiwan, Hong Kong and Macau.
James Xue
Chairman, President/CEO, Canbridge

known as the partner of choice in China and greater Asia area for such opportunities.”

The remainder of Canbridge’s pipeline is more early stage. CAN- 008 for glioblastoma multiforme is already in phase I trials in Taiwan. The biotech holds the greater China rights for CAN-008, which has been designated a MAH (marketing authorization holder) pilot project in China where it is seeking an IND. In addition, Canbridge’s CAN-017 is also seeking an IND in China for squamous cell esophageal cancer. Canbridge holds global rights for CAN-017, excluding North America. ,

Posted on

China’s Canbridge nabs Puma’s Nerlynx for HER2+ breast cancer in $70M deal

BioWorld

The news source of record covering the development of innovative human therapies

Actionable Intelligence • Incisive Analysis

February 7, 2018 Volume 29, No. 26

http://www.bioworld.com/content/chinas-canbridge-nabs-pumas-nerlynx-her2-breast-cancer-70m-deal-0

or click here for a PDF version BioWorld 2

China’s Canbridge nabs Puma’s Nerlynx for HER2+ breast cancer in $70M deal

By Shannon Ellis, Staff Writer

SHANGHAI – Beijing’s Canbridge Life Sciences Inc. has acquired the greater China rights to Puma Biotechnology Inc.’s Nerlynx (neratinib) as an adjuvant for early stage HER2-positive breast cancer and other HER2 tumors, such as gastric cancer, which is highly prevalent in China.

The deal will provide Puma with an up-front payment of $30 million, with the possibility of another $40 million upon regulatory milestones. Royalties and sales milestones could also provide Puma with further payments.

Nerlynx, an irreversible tyrosine kinase inhibitor, was approved by the U.S. FDA in July. But the Los Angeles-based company encountered pushback from Europe’s regulators, with the Committee for Medicinal Products for Human Use (CHMP) indicating a negative trend vote last month. (See BioWorld, July 19, 2017, and Jan. 25, 2018.)

With poor prospects in Europe, Canbridge remains steadfast about Nerlynx’s chances in greater China. “We assessed the opportunity and even with the recent news from Europe, we will not waver in terms of our position to get this product to patients in China,” James Xue, Canbridge chairman, CEO and president, told BioWorld. “I want to emphasize this is a brand new drug that received U.S. FDA approval in an area that has very little treatment options and has a strong case for us to present to the authorities in our geographies, including mainland China, Taiwan, Hong Kong and Macau.”

Nerlynx is approved in the U.S. as an adjuvant for patients using Herceptin (trastuzumab, Roche Holding AG)-based therapy with HER2-positive breast cancer. About 20 percent to 25 percent of breast cancer patients overexpress the HER2 protein.

After a course of Herceptin, patients often have no additional treatment options, explained Xue. Depending on the individual, within about five years a significant number of patients – up to 25 percent – will find the cancer recurs in a very vicious form. Many patients lacking treatment options will die within six months; Xue called it “a very dire situation.” In China, that is especially so. “In terms of Chinese patients, the Chinese breast cancers are more aggressive compared to the western form and occur in a younger age group relative to the western patient population,” said Xue.

Assessing the global phase III MRCT data from Puma, Xue said a significant number of patients taking Nerlynx had reduced rates of recurring cancer vs. the comparator (according to Puma’s release it can be 34 percent). “This is a major accomplishment and clinical benefit for patients who do not have recurring cancer; they will live over five years,” Xue said. “And for those with recurring cancer, it allows those patients to have a chance at extended disease-free survival.”

Accelerated approval in China possible
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The large amount of data that Puma collected in its global pivotal study may help Canbridge seek accelerated approval in China. Post-ICH (International Council for Harmonisation) admittance, China’s regulators have said they will accept global data. Since a portion of the data collected by Puma also included Chinese patients and those of Asian ethnicity, there is a chance that Canbridge may be able to seek approval without a clinical study in China, or only a limited one.

“We believe that we will be able to leverage the existing data to a maximum extent for a shortened market approval pathway,” said Xue. “We will leverage the data that Puma has already built on a global scale, including Asian patients with their pivotal study. Over 2,000 patients enrolled in the pivotal study over five years – it is one of the most sophisticated studies ever done in breast cancer.”

But in Europe, regulators have raised concerns over the clinical relevance and risk-worthiness of Nerlynx in extended adjuvant use for women with early stage, HER2-positive breast cancer and asked for Puma to take “additional steps.”

Puma said the CHMP found a benefit-risk assessment for Nerlynx to be negative since it was based solely on evidence from a single pivotal trial and because “two- and five-year invasive disease-free survival benefits observed to date may lack sufficient clinical relevance.”

Another factor Canbridge will need to work through when discussing Nerlynx with Asian regulators are the side effects of Nerlynx, including grade III diarrhea. “Puma did a good job to educate us about how they developed effective patient management protocol for the side effects,” Xue said. “We looked at the data for the prevalence and seriousness of the diarrhea … the protocol developed by Puma should be very straightforward for us to adopt in China.”

Meanwhile, in the U.S., Puma is seeking to widen the scope of use for Nerlynx to more HER2-expressed cancers in a basket trial for patients with breast, cervical, biliary, salivary and non-small-cell lung cancers.

Canbridge will take the lead on gastric cancer, which is highly prevalent in China. The company will also seek out approval for other forms of HER2-positive cancers as well, including late-stage metastatic breast cancer in China.

Getting market ready

With many of China’s regulatory hurdles now lowered, Canbridge, like many Chinese biotech startups, is getting market ready for the first time. The firm’s plan is to see Nerlynx on the market by mid-2019. In advance of that, Canbridge’s CAN-002 for mucositis caused by radiation or high-dose chemotherapy should receive CFDA approval.

“The timing of this deal is excellent in terms of building a full-fledged commercial presence which is already underway,” said Xue. “This is transformative because it accelerates our vision to build a virtually integrated company from development to full commercialization. My team and I are very excited about Puma’s decision to choose us as a partner. We want to be

 “I want to emphasize this is a brand new drug that received U.S. FDA approval in an area that has very little treatment options and has a strong case for us to present to the au­thorities in our geographies, including main­land China, Taiwan, Hong Kong and Macau.

James Xue

Chairman, President/CEO, Canbridge

known as the partner of choice in China and greater Asia area for such opportunities.”

The remainder of Canbridge’s pipeline is more early stage. CAN- 008 for glioblastoma multiforme is already in phase I trials in Taiwan. The biotech holds the greater China rights for CAN-008, which has been designated a MAH (marketing authorization holder) pilot project in China where it is seeking an IND. In addition, Canbridge’s CAN-017 is also seeking an IND in China for squamous cell esophageal cancer. Canbridge holds global rights for CAN-017, excluding North America.

Posted on

Scrip Asks… What’s The Current Climate For Deal-Making? (Part 1)

Scrip Asks… What’s The Current Climate For Deal-Making? (Part 1)

  • 16 Oct 2017

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Joseph Haas Joseph.Haas@informa.com

Executive Summary

Following Gilead’s acquisition of Kite, buzz grew that the deal might catalyze a surge in deal-making. Scrip asked a broad cross-section of biopharma insiders and observers about the deal-making environment – first up are responses from small biotechs.

Gilead Sciences Inc.‘s recent buy-out of Kite Pharma Inc. for $11.9bn to super-charge its cancer pipeline ended a long period of speculation about what Gilead would do with its stockpile of cash – and set off a new round of speculation about the state of the deal-making environment across the biopharma industry.

What’s Gilead Getting From Kite For Nearly $12bn?

By Mandy Jackson 29 Aug 2017

The $180 per share that Gilead’s paying for CAR-T maker Kite was deemed too high by some and just right by others, but the big biotech expects a lot from its new cell therapy platform.

Read the full article here

Scrip asked a cross-section of people in the industry – from large and small companies, market analysts and other industry observers – what they make of the current climate for deal-making. Here, in their own words, are the responses from the biotech sector, defined here as smaller, clinical-stage firms. Part two will provide the responses from big pharma and other respondents.

Having Their Say:

Biotech: Epizyme Inc., Erytech Pharma SA, Kura Oncology Inc., Zavante Therapeutics Inc., CytomX Therapeutics Inc., Fortress Biotech Inc., CANbridge Life Sciences Ltd., Athersys Inc., Corbus Pharmaceuticals Holdings Inc.

Susan Graf, Chief Business Officer, Epizyme

Susan Graf

The current deal-making environment is a positive one-two punch for biopharma. First, today’s equity climate is fueling biopharma companies in their work to discover and develop innovative therapies. Second, big pharma companies continue to need promising new assets to fill their pipelines.

This exciting combination creates a variety of options for biopharma companies as they consider the best way to add more value to their companies, while continuing to do what they do best: innovating new medicines, particularly in areas of large unmet patient need.

Jean-Sebastien Cleiftie, Chief Business Officer, Erytech

Jean-Sebastien Cleiftie

Our perspective on the current climate: although not at the level of 2015, 2017 year-to-date biotech deal-making levels have been robust, especially when we look at licensing in oncology, immuno-oncology and immunology, which will continue to drive transaction activity.

Biotech M&A levels have been contained through the summer, although one transaction can have a dramatic effect on deal statistics, as shown by the recent acquisition of Kite Pharma by Gilead. Furthermore, Q4 is generally an active quarter for deal making, so all in all it is too early to predict what 2017 will look like on the M&A front.

Troy Wilson, CEO, Kura Oncology

Troy Wilson

Although uncertainty around tax reform and drug pricing remains, we continue to see a constructive deal-making environment for biopharma. Companies and investors continue to seek deal premiums, and buyers appear to be exercising discipline. Large pharma are willing to pay a premium when products have been significantly de-risked while smaller companies must compete aggressively as they look to challenge the incumbents.

As a result, we are seeing companies such as Incyte Corp., Tesaro Inc., Clovis Oncology Inc. and others begin to expand their scope and become strategic partners in their own right. In general, it makes for a pretty healthy biopharma ecosystem.

“This feels more like a slowdown as [big pharma] integrate their previous acquisitions and they assess what is going to happen with pricing and reimbursement.” – Zavante’s Schroeder

Ted Schroeder, President and CEO, Zavante Therapeutics

Ted Schroeder

I would characterize the current deal climate as active, but cautious. I find the current situation interesting for two reasons 1) Money is still relatively cheap and 2) Most companies remain under-valued. While I don’t have great insight into the minds of big pharma, this feels more like a slowdown as they integrate their previous acquisitions and they assess what is going to happen with pricing and reimbursement.

Allergan PLC’s shift to deals that are accretive in the short term (e.g. aesthetics) likely gives the rest of the players the sense that they don’t have to be quite so aggressive for therapeutic deals. (Also see “Allergan Adds Accretive Aesthetics Assets In $2.9bn LifeCell Acquisition” – Scrip, 21 Dec, 2016.) Novel oncology assets still seem to be in high demand. Big pharma and biotech still need to fill their pipelines so I expect a steady deal flow going forward, but perhaps not quite like 2016.

Debanjan Ray, CFO and Head of Corporate Development, CytomX

Debanjan Ray

We find the current biopharma deal-making environment to be strong. Our recent interactions with pharma suggest that these companies value innovation, and are willing to think creatively to access innovative programs and platforms that have the potential to make a difference for patients.

In the past 18 months, we’ve closed collaborations with AbbVie Inc., Bristol-Myers Squibb Co.and Amgen Inc. In these collaborations, our partners have been willing to structure deals that bring value to CytomX in the near term and the long term – for example, retention of certain development responsibilities and profit splits on certain products. This sort of creativity in deal structuring is highly valued by biotech companies such as CytomX, and tend to result in more productive collaboration discussions between biotech and pharma.

Lindsay Rosenwald, CEO, Fortress Biotech

Lindsay Rosenwald

I think the climate is as good as it’s ever been. There’s a great feel of demand for novel drug therapies in big pharma, big biotech, specialty pharma and even mid-sized and smaller companies so it all looks good right now. Which is always scary, right?

When I go to conferences, they’re very crowded with lots of inquiries, lots of interest and it’s like a bazaar, there’s so many people interested in so many different programs. If you look at the announcements of all the deals, it seems there’s a good volume of them.

From my perspective, because we’re involved in lots of different technologies, lots of different companies, there is certainly a lot of interest from all parts of the industry and it seems like the demand for novel agents addressing unmet medical needs – I’ve never seen the demand as great as it is right now.

“Capital market access for follow-on offerings has become somewhat more challenging since the peaking of sector performance in 2015. We believe this creates a very favorable environment for deal-making, as companies look to identify alternative funding sources.” – CANbridge’s Xue

James Xue, Founder, Chairman and CEO, CANbridge Life Sciences

James Xue

We are very optimistic about the current deal-making environment in the biopharma industry, which has seen historic inflows of capital over the last five years and a record number of IPOs. With that influx of capital, exciting new therapeutic candidates have received much needed initial funding to support their advancement. However, capital market access for follow-on offerings has become somewhat more challenging since the peaking of sector performance in 2015. We believe this creates a very favorable environment for deal-making, as companies look to identify alternative funding sources.

Our particular model is to identify validated Western drug candidates for development and commercialization in China and northern Asia. In this sector, we are observing a rise in cross-border transactions between Western and Chinese companies, such as the recently announced agreement between Celgene Corp. and BeiGene (Beijing) Co. Ltd. (Also see “Celgene Eyes IO Growth With BeiGene China Pact” – Scrip, 6 Jul, 2017.) These types of deals can allow companies access to markets not otherwise easily accessed, as well as additional non-dilutive capital, which we believe will continue to make them attractive and a growing component of the environment.

Gil Van Bokkelen, CEO, Athersys

Gil Van Bokkelen

There is substantial interest in technologies that have the potential to address areas of significant unmet medical need, and we believe that will continue to be the case. This is especially true for innovative technologies targeted at indications that are related to the unprecedented demographic transition now occurring, with the large increase in the number of people age 65 and older as the baby boom generation gets older. This will have a massive global impact on health care, since there are quite a few diseases and conditions that will become more prevalent as the global population ages.

Unfortunately, many of these conditions currently lack effective treatment solutions, and for the patients that may mean institutional care, family care or professional home health care, and most families and societies around the world are simply unprepared for that. That need creates opportunities for innovative companies developing safer and more effective treatment solutions that can help improve quality of life for patients.

“We’ve been hearing from big pharma … that there is real concern over high valuations of late-stage public companies that could be targets.” – Corbus’ Cohen

Yuval Cohen, CEO, Corbus

Yuval Cohen

There has been a real drought in deals this year and so the recent Gilead/Kite deal was a very welcome change in that. It is probably too soon to see whether that was the start of a change or a one-off. What we’ve been hearing from big pharma is that there is real concern over high valuations of late-stage public companies that could be targets, but that is always counteracted by the ever-present need of big pharma for novel promising drugs in their pipelines. My feeling is that we will see a return to robust M&A activity shortly but perhaps more on the earlier (hence less expensive) side.

 

Posted on

BRIDGE TO INNOVATION

While Zai L ab L td. has joined the ranks of Chinese biotechs making a splash on NASDAQ, less noticed may be the first wave of China-based players moving into Boston to jump-start their push into novel drug development.

This year has seen Chinese pharmas like Qi l u Ph ar maceu ti cal Co. L td. and L u ye Ph ar ma Gr ou p L td. open R&D operations in the East Coast life sciences hub, viewing the city as a gateway to top-tier translational  science and scientific talent  as well  as potential partners.
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Biologics Blossoming: CANbridge Looks To Taiwan, WuXi Partners Juno

PharmasiaNewsBiologics Blossoming: CANbridge Looks To Taiwan, WuXi Partners Juno

By Brian Yang

Apr. 11, 2016 7:05 AM GMT

https://www.pharmamedtechbi.com/Publications/Pharmasia-News/2016/4/11/Biologics-Blossoming-CANbridge-Looks-To-Taiwan-WuXi-Partners-Juno?result=1&total=22&searchquery=%253fq%253dCANbridge

Executive Summary

New policies including the allowance of contract manufacturing under a new marketing holder system are fast changing the nascent biologics sector in China, where the just 2% market penetration for such products is offering plenty of room for a new crop of startups including CANbridge to grow and thrive.

BEIJING – Many seemingly unconquerable barriers of the past are fast melting away, and biotech companies in China are wasting no time to seize new opportunities.

One such obstacle has been manufacturing site requirements. Previously in China, drug makers must have had their own production facilities to be able to conduct clinical trials for their new drugs, but now a pilot program is allowing contractor manufacturers to be used instead (“Authorization Holder Scheme To Shake Up China R&D, Production” — PharmAsia News, Nov. 6, 2015 4:18 AM GMT).

That is opening doors for smaller biotech startups like CANbridge Life Sciences Ltd. With fewer than 20 people and a virtual development model, the Beijing-based firm simply has to rely on contract manufacturing organizations (CMOs) for any chance of developing a new drug in China.

Now, the company has a concrete solution. It has signed up with WuXi Biologics, a subsidiary of WuXi AppTec Inc. to produce CAN-008 in China. The molecule, also known as APG001, was licensed by CANbridge in July 2015 from Germany’s Apogenix GMBH for mainland China, Hong Kong and Macau, and is at the clinical stage elsewhere for glioblastoma multiforme, a type of brain cancer.

The partnership with WuXi will allow CANbridge to submit a planned IND for clinical trials to the China FDA. Wasting no time, the company has meanwhile completed an IND application (the venture’s first) to initiate a Phase I/II trial in Taiwan (which is now included in its licensed territories) to help expedite the regulatory process in the mainland, disclosed James Xue, CANbridge’s CEO.

“Due to a ‘four plus four’ agreement between the mainland and Taiwan, in which clinical trial study data from four selected facilities from each side are accepted by the [respective] regulatory agencies, we hope the data obtained from the Taiwan study will be used towards starting Phase II trials in the mainland, bypassing a Phase I study [in China],” explained Xue in a phone interview. Data from the Taiwan study are expected next year, he added.

Such a development approach is a direct result of a cross-strait clinical study collaboration agreement, a pathway that several Taiwanese biotechs including Taiwan Liposome Co. Ltd. are hoping to use to get their novel drugs approved in a far larger market (“Taiwan Liposome Eyes Phase II Liver-Cancer Drug Trials At Home, China” — PharmAsia News, Aug. 11, 2014 10:33 PM GMT).

CANbridge has also recently in-licensed global rights ex-US, Canada and Mexico to AVEO Oncology‘s clinical stage ErbB3 (HER3) inhibitor for esophageal squamous cell cancer (ESCC) (“CANbridge Looks Beyond Asia With AVEO’s Oncology Drug” — PharmAsia News, Mar. 24, 2016 7:59 AM GMT).

Clinical Benefits Matter

Unlike its biotech peers, which are focusing on cancer types that are prevalent in China such as lung, liver and gastric cancer, Xue’s firm is fixing its eyes on brain tumors and esophageal squamous cell carcinoma. The executive said that although patient numbers matter, identified patients and clinical benefits carry more weight.
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Glioblastoma multiforme is the most prevalent and aggressive form of brain cancer, and the current standard first-line treatment is Temodar (temozolomide injection), a chemotherapy agent developed by Merck & Co. Inc. and first marketed in 1999.

The average survival in the malignancy is roughly seven months, resulting in a large unmet medical need, Xue said.

A CD95-Fc fusion protein in the TNF family, APG101 is currently under Phase II study for glioblastoma and is the first targeted therapy for the indication in late-stage development, with Apogenix planning to start a Phase III program in Europe.

Although the drug is being studied as a second-line therapy in Europe, the 55-patient Taiwan study (set to start in August) will test it in the first-line setting in combination with temozolomide, during and after radiation therapy. The data generated are also expected to complement the Apogenix data obtained in Europe, Xue said.

“A clear pathway and potential benefits to patients” provided CANbridge with the main reasons to license the asset for greater China. Additionally, Xue said the company is also looking to expand to other cancer indications once it obtains proof-of-concept data. APG101 is already being developed for myelodysplastic syndromes, where CANbridge has an option to acquire selected rights.

Similarly, there is a lack of effective treatments for ESCC, which affects people in certain regions of China.

MAH Impact

China’s rollout of the marketing authorization holder (MAH) pilot scheme is enabling smaller biotechs like CANbridge to file for their own regulatory approvals for the first time. “MAH is opening the door,” Xue pointed out, adding that WuXi is one of the few CMOs with international standards.

Another factor is that WuXi has experience filing new drug approvals with the China FDA. Even as the goal is to develop the Apogenix asset into an international first-in-class drug, Xue said manufacturing such a product will even be a new challenge for WuXi.

In another move under the MAH scheme, German’s Boehringer Ingelheim GMBH has also set up a CMO subsidiary in China and has partnered with BeiGene (Beijing) Co. Ltd. to manufacture BeiGene’s anti-PD-1 monoclonal antibody BGB-A317 (“Beigene/Boehringer Biomanufacturing Bond Tests China MAH System” — PharmAsia News, Mar. 10, 2016 6:28 AM GMT).

WuXi Links With Juno

Meanwhile, WuXi – China’s largest contract research organization – has been busy signing other deals, including wit Juno Therapeutics Inc. to set up a 50/50 joint venture, JW Biotechnology (Shanghai) Co. Ltd, to develop immune-oncology products in China.

The JV will leverage Juno’s technology in chimeric antigen receptor (CAR) and T-cell receptor drugs and WuXi’s R&D and manufacturing capabilities, and plans to in-license the rights in China to Juno products in exchange for undisclosed upfront, milestone and royalty payments.

The new joint venture is being led by WuXi’s co-founding CEO James Li, formerly a partner with Kleiner Perkins and GM for Amgen Inc. in China, while WuXi chairman Ge Li serves as chairman. Other board directors include Juno CEO Hans Bishop, Juno CFO Steve Harr and WuXi CFO Edward Hu.

Juno is one of the portfolio firms that had previously received investment from WuXi Healthcare Ventures (“WuXi AppTec Aiming To Relist Biologics Unit In Hong Kong IPO” — PharmAsia News, Mar. 4, 2016 1:21 AM GMT).

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UPDATED: China’s CANbridge files Taiwan IND for PhI/II anti-TNF candidate

FiercePharmaAsiahttp://www.fiercepharmaasia.com/story/chinas-canbridge-files-taiwan-ind-phiii-anti-tnf-candidate/2016-04-07

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Clinical trials | Partnering

UPDATED: China’s CANbridge files Taiwan IND for PhI/II anti-TNF candidate

Adds comments from Xue

April 7, 2016 | By EJ Lane

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Beijing-based CANbridge Life Sciences has sent the Taiwan FDA an Investigational New Drug (IND) application for candidate CAN-008 aimed at brain cancer immunotherapy that was in-licensed for China rights from Germany’s Apogenix.

 CEOJamesXue

CANbridge Chairman and CEO James Xue

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The Taiwan trials will see CAN-008 administered with temozolomide (Temodar) along with radiation therapy for 55 patients in the open-label, dose-escalation Phase I on safety, tolerability pharmacokinetics and preliminary efficacy, according to a press release.

The WuXi Biologics unit of Shanghai-based WuXi AppTec will manufacture the candidate in China, aiming to use the speedier IND process in Taiwan as a possible springboard into Mainland China, though the pathway relies on China FDA granting a fast-track review.

“We are delighted to join forces with WuXi, which will manufacture CAN-008 for the Chinese market, where we plan to begin the pre-clinical work immediately, preparatory to an IND submission,” James Xue, CANbridge Chairman and CEO, said in a statement. CANbridge will rely on WuXi for CD-95 fusion protein.

In a phone interview with FiercePharmaAsia, Xue said that patient enrollment should be finished by the end of the year and results for the Phase I leg out by the second quarter of 2017. He said the trial was being conducted under a 4 + 4 arrangement between Taiwan and China that recognizes clinical trial data from 4 hospitals in each country.

In that regard, CANbridge hopes to take successful Phase I data to the China FDA for an IND application and if the data is exceptional – aim for a straight shot into Phase II without having to repeat the Phase I in China.

With a bit more than $15 million raised up to Series A, Xue expects Series B cash this year at around twice that amount to carry on work through 2018, adding that he sees the biotech space in China moving to a “self-select” mode in funding in the coming years as excellent talent and candidates are in place now.

The multi-center, double-blind, randomized, placebo-controlled Phase II leg of the trial eyes efficacy and safety with a start date seen in August of this year.

Apogenix’s own efforts in a Phase II trial in Europe saw increased median survival to 16.1 months from 6.5 months and meeting efficacy endpoints and no serious adverse effects.

In March, CANbridge inked a deal worth a potential $134 million deal with Nasdaq-listed Aveo Oncology ($AVEO) for a clinical-stage ErbB3 (HER3) antibody candidate AV203.

CANbridge received $10 million in venture capital financing in October of last year, led by Qiming Venture Partners and TF Capital, the venture arm of Chinese CRO Tigermed, which built on angel investor funding of the same amount received in 2014.

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CANBRIDGE CAN-CAN

BY STEPHEN HANSEN, ASSOCIATE EDITOR

Canbridge Life Sciences Ltd.’s deal with Aveo Pharmaceuticals Inc. will see the Chinese biotech developing its first programs outside Asia. But Chairman and CEO James Xue says the company is not deviating from its strategy, which is focused on in-licensing clinical assets from the West to target diseases prevalent in Asia. In this particular case, it made sense to take rights to Aveo’s AV-203 in all territories outside North America because the target indication also plays to Canbridge’s experience with Orphan diseases in the West.
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CANbridge Looks Beyond Asia With AVEO’s Oncology Drug

PharmasiaNews

CANbridge Looks Beyond Asia With AVEO’s Oncology Drug

By Jung Won Shin / Mar. 24, 2016 8:00 AM GMT

Executive Summary

In its first venture outside of Asia and a rare move by a Chinese biopharma firm, CANbridge Life Sciences is acquiring global rights to AVEO’s clinical-stage ErbB3 (HER3) inhibitory antibody candidate, in a step CANbridge’s CEO explains fits well with the company’s global strategy and therapeutic focus.

SEOUL – CANbridge Life Sciences Ltd. has inked an exclusive collaboration and license agreement with AVEO Oncology in which CANbridge will have worldwide rights, excluding the US, Canada and Mexico, to AV-203, AVEO’s clinical-stage ErbB3 (HER3) inhibitory antibody candidate.

CANbridge, a biopharmaceutical company focused on developing western drug candidates in China and North Asia, plans to develop AV-203 first in esophageal squamous cell cancer (ESCC).

“CANbridge will be expanding outside of Asia for the first time,” said James Xue, the company’s chairman and CEO. “Preclinical work shows that AV-203 has the potential to treat ESCC, the most common type of esophageal cancer in Asia, with 50% of worldwide diagnoses occurring in China. Esophageal cancer is also prevalent in other parts of the world, particularly developing countries.

“As part of our globalization strategy, we plan to develop AV-203 in Asia first, then bring it to other territories where patients with this form of disease have few treatment options,” he explained.

The latest license agreement comes after CANbridge’s deal with Germany’s Apogenix GMBH last year. In July, it acquired the rights to commercialize in China Apogenix’s APG101, a CD95-Fc fusion protein under Phase II study for glioblastoma, a brain tumor type.

Strategic Focus

The Beijing-based drug discovery company will primarily concentrate on oncology for now, Xue told PharmAsia News.

“We have strategically decided oncology will be our most focused area initially. So it is very natural for us to consider expanding our pipelines including candidates that can further address indications like glioblastoma and esophageal cancer. Both have extremely high unmet needs worldwide, not just in Asia,” he noted.

“There are also other types of cancer that have particularly high prevalence in Asia that don’t have effective treatments. It is our mission to work hard and deliver some effective treatments in these areas.”

According to the World Health Organization, esophageal cancer is the eighth most common cancer globally, with over 450,000 cases diagnosed each year.

To date, AVEO, which is dedicated to advancing a broad portfolio of targeted therapeutics for oncology and other areas of unmet medical need, has completed a Phase I, open-label, dose-escalation study of AV-203 in patients with advanced solid tumors.
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In this study, AV-203 was found to be generally safe and well-tolerated, with an early signal of activity consistent with preclinical data showing the potential for heregulin, the only known ligand for ErbB3, to serve as a biomarker predictive of AV-203 anti-tumor activity.

Deal Details, Clinical Plans

Under the terms of the agreement with AVEO, CANbridge Life Sciences is obligated to pay AVEO an upfront payment of $1m plus up to $133m in potential reimbursement and milestone payments, assuming the successful achievement of specified development, regulatory and commercialization objectives.

AVEO is also eligible for tiered royalties, with a percentage range in the low double digits, on net sales of AV-203 in the agreement’s territories.

CANbridge Life Sciences will be responsible for costs associated with the execution of a development plan that includes additional manufacturing requirements as well as preclinical and clinical studies necessary to demonstrate proof-of-concept for AV-203 as a treatment for squamous cell esophagus cancer, including a Phase IIa proof-of-concept study meeting mutually agreed upon criteria.

“Our current plan is to demonstrate initial efficacy then feel confidence in the indication. Afterward, we will consider multinational studies. Whether in Asia or beyond Asia, we haven’t decided it yet,” the CEO said. “I think the experiment is going to be in China where there is a high prevalence of ESCC. We will start the Phase I in China next year.”

“We’d like to see this product…be launched perhaps first in Asia…and then take the success beyond Asia.” – James Xue, chairman and CEO, CANbridge

The company plans to conduct Phase IIa in China in a couple of years, he added.

Following completion of the proof-of-concept studies, AVEO and CANbridge will negotiate a possible agreement under which they may co-develop AV-203, with each party bearing a percentage of the cost of global development activities based on respective geographic rights.

If the parties fail to reach such an agreement, CANbridge may continue the development of AV-203 on its own in markets outside of the United States, Canada and Mexico.

Asia First, Global Second

Speaking on the company’s global strategy, the Xue said if the company has an effective and promising candidate which has global impact beyond China and Asia, it will be happy to see the therapy utilized.

“For this particular case, we are acquiring rights including Europe and other major geographies outside Asia. Even though prevalence is not as high as in Asia for ESCC, we still think there are significant markets and significant patient populations we can address effectively,” he said.

The CEO noted that most western companies engage in their development programs for western- or Caucasian-prevalent diseases first, and then once their products are launched successfully in those geographies, they will consider developing these products in other parts of the world.

“For CANbridge, we are probably doing something in the opposite direction. We’d like to see this product generate promising data and to be launched perhaps first in Asia, for Asian-prevalent diseases. And then take the success beyond Asia. That is our global strategy,” he said.