Posted on

PATIENTS LEAD THE WAY

Click here to read the full article…

BY EMILY CUKIER-MEISNER, SENIOR WRITER

FDA’s draft guidance on Duchenne muscular dystrophy and related
dystrophinopathies is the culmination of an extensive e6ort led by a
patient advocacy group that enlisted the support of patients, caregivers,
academia and industry.
DMD drug development has been hindered by a lack of defined outcome
measures and understanding of surrogate markers or biomarkers that
Relationship Between Uric Acid and Erectile Dysfunction Uric acid is blamed to be the main culprit when it actually comes to gout and as such, it has become an interesting factor of concern while talking about lovemaking conditions including ED. cialis discount pharmacy People due to certain work load or stress tend to a victim of some worst issues which can be controlled through diet therapy and exercise therapy, the rest all need drug treatment. lowest price for viagra Suppose there was a female libido enhancer that would be just as effective. best soft cialis The effects are not for very long and are simply for the viagra prescription purpose of intercourse. could support approval. To address this, FDA invited Parent Project
Muscular Dystrophy (PPMD) and the DMD community to submit a
proposed draft guidance that could clarify a clinical development pathway
for approval.
FDA spokesperson Kristofer Baumgartner said in a statement to
BioCentury that PPMD’s submission is the first time in the Center for
Drug Evaluation and Research’s knowledge that an advocacy group has
submitted a proposed draft guidance, and that this type of engagement is
an example of how early input from patients and caregivers can contribute
to drug development.

Posted on

Duchenne Muscular Dystrophy: Idebenone Slows Respiratory Decline in Phase 3 Trial

NEUROLOGY TODAY

http://journals.lww.com/neurotodayonline/blog/NeurologyTodayConferenceReportersAANAnnualMeeting/pages/post.aspx?PostID=11&cid=MR-eJP-AANConference-Day4US-Neurology-WNT-NoPromo&desktopMode=true

Friday, April 24, 2015

April 24—Duchenne Muscular Dystrophy: Idebenone Slows Respiratory Decline in Phase 3 Trial

BY RICHARD ROBINSON

WASHINGTON—Idebenone slows the decline of respiratory function in boys with Duchenne muscular dystrophy (DMD), according to a yearlong, double-blind phase 3 trial in 64 boys. Lead investigator Gunnar Buyse, MD, PhD, a professor of pediatrics and child neurology at the University of Leuven in Belgium, presented the results here on Friday at the AAN Annual Meeting.

Boys receiving 900 mg per day of idebenone for 52 weeks experienced a non-significant decline in peak expiratory flow as percent predicted (PEF%p; -3%p), the primary outcome measure, compared with a significant decline (-9%p) in those receiving placebo. This represents a 66% reduction in loss of PEF%p. PEF%p is a measure of peak flow (respiratory strength) compared with height -corrected norms for the population. Other respiratory measures were also significantly different between the two groups.

“This is the first ever successful phase 3 trial in this complex disease,” Dr. Buyse told the Neurology Today Conference Reporter before the session.

The major reason behind the problem of impotence is generic viagra soft no more an issue of concern but if the problem persists for half or more times you encounter a sexual intercourse then the problem demands treatments. Causes prompting this health cialis 100mg pills issue in men include relationship issues, depression, prostate gland injury, vascular disorder, etc. sildenafil price Ammonia itself is a by-product of intensive exercise, and without the urea cycle the body would rapidly become polluted. However, cialis from india tadalafil working through such issues with a partner can help for preventing impotence condition. Idebenone is a synthetic quinone compound with both electron transfer and antioxidant effects, Dr. Buyse said. “We know that in DMD cells there is a problem with oxidative stress, as well as with energy production.” Idebenone works in the mitochondrial electron transport chain to increase energy production and reduce oxidation, he explained.

In the mdx mouse model of DMD, idebenone has been shown in blinded experiments to improve cardiac function over nine months of treatment, as well as to increase the level of voluntary exercise. A successful phase 2 trial of idebenone in DMD set the stage for the current trial.

Enrolled patients were between 10 and 18 years old and were not currently taking steroids; about 90 percent had progressed to requiring a wheelchair for mobility. Peak expiratory flow was chosen as the primary endpoint after conferring with regulators, Dr. Buyse said. It is a direct measure of strength or weakness of the expiratory muscles, unlike forced vital capacity, which can also reflect the degree of scoliosis or other comorbidities. “There is good evidence that peak flow is an earlier and more sensitive parameter than forced vital capacity,” he said.

In addition to the effect on peak expiratory flow, the benefits of treatment were seen on forced vital capacity and forced expiratory volume in one second. The researchers observed no difference in benefit between boys who had or had not previously used steroids. Treatment was safe and well tolerated. “It is really a coherent picture showing the beneficial effect of the intervention,” Dr. Buyse said.

Based on the results from this trial, the investigators plan to apply for regulatory approval in both the United States and Europe. If the drug is approved, it will be considered for use earlier in the disease than was tested in the trial. “In principle, there is no reason idebenone would not work earlier,” Dr. Buyse said. Based on both its mechanism of action and some subanalyses showing that younger patients in the trial benefited equally compared with older ones, he added, “there is every reason to think that the sooner you start it, the better it would work.”

Kathryn R. Wagner, MD, PhD, director of the Center for Genetic Muscle Disorders at the Kennedy Krieger Institute in Baltimore, MD, cautioned, however, that these results apply directly only to boys not currently taking steroids. “From this trial, we do not know if idebenone will provide benefit to boys who are receiving this standard-of-care treatment,” said Dr. Wagner, who was not involved with the study.

A further caveat is that PEF%p “is not a measure that is used clinically in DMD, and it is difficult to know its relevance,” Dr. Wagner said, adding that this could be a concern unless it can be shown to be predictive of a more clinically relevant measure, such as the need for ventilation or decreased respiratory infections.

Nonetheless, she said, “Novel drugs are desperately needed in Duchenne muscular dystrophy. We assume that drugs that improve skeletal muscle function will improve pulmonary function, but this may be an oversimplification. A trial focusing on adolescents and pulmonary function is therefore welcomed.”

Posted on

Plaque Array method links blood plaque components to Alzheimer’s

Click here to read full article…

Study on Plaxgen
Alzheimer’s disease blood
diagnostic published in
peer-reviewed journal

BY LLOYD DUNLAP

SUNNYVALE, Calif.—Plaxgen Inc., a developer
of flow cytometry-based blood diagnostics for
plaque-associated illnesses such as atherosclerosis
and Alzheimer’s disease, announced that a paper
validating its Plaque Array technology for the diagnosis
of Alzheimer’s disease was published in the
peer-reviewed journal Clinica Chimica Acta.
In a study titled “Plaque Array Method and Proteomics-
based Identification of Biomarkers from
The erection is not viagra prescription free as rigid or hard as a natural erection; drugs or injections, when they work, may be preferable. The L-Arginine Benefits for Health: So what additional L-Arginine benefits should you know about? First, L-Arginine can be help boost the invention online cialis mastercard http://ronaldgreenwaldmd.com/procedures/ of nitric oxide in spongy tissues of penis which results in quicker and firmer erections. Men have become aware of the fact that ED, although incurable, is treatable with effective oral medicine. viagra prices online To know more about kamagra and its potential benefits, please talk to a qualified viagra soft 50mg doctor. Alzheimer’s Disease Serum,” researchers concluded
that the Plaque Array methodology developed by
Plaxgen works well for detecting amyloid beta
(Abeta) and other particle formation in the blood
serum of subjects clinically determined to have
Alzheimer’s disease (AD).
As stated in the paper’s abstract, progressive
accumulation of amyloid plaques in the regions
of brain, carotid and cerebral arteries is the leading
cause of Alzheimer’s disease and related dementia
in affected patients. The early identification
of individuals with AD remains a challenging
task reliant on symptomatic events, and thus the
development of a biomarker-based approach will
significantly aid in the diagnosis of AD.

Posted on

Results from Phase III trial of Raxone/Catena in patients with DMD published

euroPharmReview

21 April 2015  •  Author: Victoria White

Home

Santhera Pharmaceuticals have announced that the full results of the double-blind placebo-controlled Phase III trial (DELOS) demonstrating efficacy and safety of Raxone®/Catena® in patients with Duchenne muscular dystrophy (DMD) have been published in The Lancet.

euroPharmReview2The results of the DELOS trial demonstrated that Raxone/Catena (INN: idebenone) significantly reduced the annual decline in Peak Expiratory Flow (PEF as percent predicted, PEF%p) by 66% compared to patients taking placebo. Other respiratory function endpoints such as Forced Vital Capacity (FVC) and Forced Expiratory Volume (FEV1) corroborated these results and showed a consistent pattern with treatment differences supporting efficacy of Raxone/Catena over placebo in the preservation of respiratory function. Researchers concluded that Raxone/Catena represents a new treatment option for DMD patients.

Yes, it is available in doses of 25 mg, 50mg, or 100 buy vardenafil levitra milligrams. If you too are suffering from levitra generico uk erectile dysfunction, do not try to be cocky or pretend like you know the customer. In functional pancreatic disorder, there are just things you shouldn’t do to buy cheap levitra sale protect yourself, family, properties, and neighborhood from any accident or hazards either caused by negligence or lack of prior experience. cialis sample Also most online websites provide free coupons. Raxone/Catena reduced the loss of respiratory function

Gunnar M. Buyse, MD, PhD, Professor of Child Neurology at the University Hospitals Leuven (Belgium) and Principal Investigator for the DELOS trial, said, “Statistically significant and clinically relevant outcomes of primary and secondary endpoints coherently demonstrated that Raxone/Catena reduced the loss of respiratory function and that it was safe and well tolerated. I am very enthusiastic about the positive data from the trial which demonstrate that this drug represents a suitable treatment option to ameliorate a life-threatening complication of the disease.”

“With morbidity and mortality in DMD being associated with progressive restrictive lung disease and irreversible loss of lung function, these findings represent an important treatment effect and are of major clinical relevance for patients with DMD”, added Craig McDonald, MD, Professor and Chair of the Department of Physical Medicine & Rehabilitation at UC Davis (USA) and investigator of the DELOS trial.

“The degree of slowing of respiratory function loss demonstrated in DELOS is of major clinical relevance for patients with DMD”, commented Nicholas Coppard, PhD, SVP Development at Santhera. “Based on this benefit and its well-established safety profile, we are very excited about the prospects of Raxone/Catena as a treatment option for DMD patients and we are currently preparing the regulatory filing dossier for application of marketing authorization both in the US and Europe.”

 

Posted on

EuroBiotech: More Articles of Note

EuroBiotechReportEuroBiotech: More Articles of Note

http://www.fiercebiotech.com/story/eurobiotech-more-articles-note/2015-04-09

Symptoms: Like a few pills, even it has its undesirable impacts however with it , the aftermaths are gentle and short-dwelled. buy generic sildenafil frankkrauseautomotive.com I’ve got an excellent email scrambler you can viagra prescription download for free right here. Thus, Zenegra tablets may seem the right option for male impotence that may possibly be recommended by your doctor. wholesale sildenafil It usually comes in small sachets and is available in three diverse forms and these are: Kamagra Tablets 1Although the tablet form is available in viagra italy there diverse dosage strengths i.e. 25mg, 50mg and 100mg, but Kamagra 100mg is the most recommended dosage for males who have been diagnosed with such health conditions & it creates a harsh impact on their health of intimacy &. April 9, 2015

Santhera Pharmaceuticals (SIX:SANN) picked up a fast-track designation from FDA for its Duchenne muscular dystrophy drug, Catena. Phase III data on the treatment–which is known as Raxone in Europe–is currently being prepared for a new drug application. Santhera expects to meet with the FDA to discuss the filing in the coming weeks. The stock traded up 11% following the news. Release

Posted on

Santhera’s rise continues with Fast Track in DMD

BIOCENTURY

Santhera’s rise continues with Fast Track in DMD

Thursday, April 9, 2015

http://www.biocentury.com/dailynews/company/2015-04-09/santheras-rise-continues-with-fast-track-in-dmd

best pharmacy viagra A radio set helps you to stay connected in situations where the spine has become unstable because of the tumor. One of the recent famous spams is on buy cialis online Google Plus. But the liver itself becomes the bait as cialis generic the toxins will be automatically removed. You feel lets end everything and go away from your life then stop certain viagra online ordering thing which urges it to still stay there. Santhera Pharmaceuticals Holding AG (SIX:SANN) gained CHF16.95 (18%) to CHF110.50 on Thursday after FDA granted Fast Track designation to Catena idebenone to treat Duchenne muscular dystrophy (DMD). The company intends to hold a pre-NDA meeting with FDA in the coming weeks.

Santhera said last May that idebenone met the primary endpoint in a Phase III study to treat DMD, delaying the loss of respiratory function in DMD patients. Its stock is now valued at nearly 30 times its price before it said idebenone met the trial’s endpoint (see BioCentury Extra, May 22, 2014).

EMA is reviewing a resubmitted MAA for idebenone, a short-chain benzoquinone, under the name Raxone to treat Leber’s hereditary optic neuropathy (LHON). Santhera expects a decision in 1H15

Posted on

Dx Firm Plaxgen Moving Plaque-based Alzheimer’s, Atherosclerosis Tests toward Commercialization

genomewebClick here to read full article…

NEW YORK (GenomeWeb) – Having spent the last seven years prepping its technology, proteomic diagnostics firm Plaxgen is now moving tests for Alzheimer’s disease and atherosclerosis towards commercialization.

The FDA purchase cheap cialis ensures that the drug is completely safe for use as it is approved by FDA. There are multiple issues that produce impaired hearing sensitivity. viagra rx For example, if someone isn’t managing their stress, the blood pressure medication becomes an “enabler,” – merely allowing deeper prescription canada de cialis stress issues to compound. In this case a preferably discount viagra cialis higher dosage is to be avoided at all costs. First in line is the company’s Alzheimer’s diagnostic, named Amyload, for which it is currently planning a validation study expected to begin in June 2015 and run through approximately January 2016, Plaxgen Founder and CEO Shanmugavel Madasamy told GenomeWeb.

The company plans to offer the test initially out of its Fremont, Calif.-based CLIA facility while simultaneously filing for US Food and Drug Administration 510(k) clearance, he said, noting that it plans to target the test to pharma firms that would use it for selecting patients for clinical trials and measuring response to treatment.

Posted on

‘Titer’-ing on brink of BLA, Adma’s added endpoints encourage outcomes in RSV

BioworldClick here to read the full article…

Recent outbreaks of respiratory syncytial virus (RSV) in Alabama, Arizona and Colorado children put renewed attention on the disease for which there is no approved therapy in adults, just as Adma Biologics Inc. reported more data from the pivotal phase III trial with RI-002 in primary immune defi ciency (PIDD) that included encouraging results in RSV and other pathogens.

“We’re unable to draw any conclusions about efficacy [against the specific infectious agents] from these increases in antibody titers, but it’s good to note that from the patients the trial was based on, we were able to generate this type of dose response, if you will,”
Adam Grossman, Adma’s CEO, told BioWorld Today. “We think it’s encouraging, and we think that clinicians, patients and payers want to know that, by infusing IVIG products, they’re getting this bump” in protection.

In early phase of Parkinson’s disease an individual’s face may show little or no expressions or his arms may online cialis pharmacy not swing when he walk. Wait for 30 t0 45 minutes drscoinc.com order viagra online for the effects to show of erection. On the other hand, with proper therapy, many people with cerebral palsy can still lead normal lives. buy viagra italy Sex is the buy tadalafil online most important action for most of the men impotence issue is caused by numerical physical issues. Company watchers enthused over the secondary endpoint results, disclosed at the American Academy of Allergy, Asthma and Immunology Annual meeting in Houston. Although Ramsey, N.J.-based Adma’s shares closed Wednesday (NASDAQ:ADMA)
at $10.05, fl at, analysts at Ladenburg Thalman set a $17.50 price target, Maxim Group went higher to $18 and Laidlaw & Co. forecast $20.

In December, Adma made known top-line data demonstrating that RI-002, a plasma-derived, polyclonal, intravenous immune globulin (IVIG) product, achieved its primary endpoint of preventing serious bacterial infections: zero, which is even below the FDA’s requirement of less than one per patient-year. The pharmacokinetic profile of total immunoglobulin G was consistent with the FDA’s guidance, too. (See BioWorld Today, Dec. 4, 2014.) Added results made RI-002’s picture even brighter. In the multisite study of 59 patients diagnosed with PIDD, researchers reported secondary endpoints that included a total of 93 days, or 1.66 days per patient per year lost from work or school due to infection, and one hospitalization due to an infection of only fi ve days duration in the entire study, with immunoglobulin G trough levels above those required by the FDA for IVIG products.

A marked increase in all of the measured specific antipathogen antibodies turned up, with the greatest increase, 5.3-fold, seen in the level of neutralizing antibody titers to RSV, which “offers an area of potential differentiation from other IVIG products and is in line with our expectations, based on the donorscreening profile,” wrote Ladenburg analyst Kevin DeGeeter in a research report. “However, we were surprised to learn that patients also reported a statistically signifi cant increase in antibody titers against two other common respiratory pathogens,” which means the compound “may have the potential to protect against a broad range of clinically important respiratory pathogens, which could strengthen the argument for premium pricing compared to other IVIG products.” Specifically, the findings showed an increase in H. infl uenzae antibodies and in S. pneumoniae antibodies.

Posted on

Canbridge takes it to next level with $10M series A from local VC backers

Canbridge takes it to next level with $10M series A from local VC backers

By Shannon Ellis
Staff Writer

Wednesday, December 10, 2014

SHANGHAI – Canbridge Life Sciences Inc., a Beijing-based biopharma company started in 2012 with angel and private capital, has received $10 million in a series A investment from leading local health care venture capital funds Qiming Ventures and TF Capital. The investment will be used to further Canbridge’s two existing in-licensed programs and put cash in its pocket to bring in more assets.

The funding comes at a crucial time for the company’s pipeline. Its development-stage candidate, ATI-1123, licensed from nanotech specialist Azaya Therapeutics Inc., of San Antonio, is ready to progress to the next stage in the clinic. It is a liposomal formulation of docetaxel to treat non-small-cell lung cancer and is expected to start phase II testing in the U.S. in 2015. (See BioWorld Asia, Sept. 25, 2013.)

Canbridge will work jointly with Azaya, taking responsibility for the phase II trial in China at the same time.

The company also has taken on board an oral rinse for the treatment of mucositis resulting from cancer treatments. Classified as a medical device, those products typically can get on the market quickly with an expedited registration process, which James Xue, founder and CEO of Canbridge, said the firm is ready to start soon.

China presents unique challenges to R&D companies with no source of revenue. The development phase is long and uncertain, and while there are some cost savings, it is increasingly expensive to do trials here. Financiers that understand how to assess the risks of biotechnology are few and far between, and with Chinese venture capitalists (VCs) having shorter life cycles than their Western counterparts, it is typically difficult for start-up biotechs to find a good match with VCs.

It does not help that only companies with a three-year track record of profits are able to go public on Chinese exchanges, complicating exits for investors.

The Canbridge announcement highlights how several of those obstacles have been overcome.

From the outset, Xue has adopted a thoughtful strategy for Canbridge, focusing on innovation to meet China’s unmet medical needs but managing the inherent risks with a “portfolio” approach – looking for assets that are in development and then balancing those with products that are approved in other markets and/or devices that are easier to get on the market. Taking on discovery is not part of the plan.

That approach helped to make Canbridge appealing to TF Capital.

“Their products have high potential here. Xue has thoroughly considered the issue of time to market to reduce our investment risk,” Kevin Chiang, partner at TF Capital, told BioWorld Asia.

TF Capital is a relatively new VC fund, started as a spin-off of well-known local contract research organization Tigermed. With only six months under its belt, TF Capital has participated in roughly eight deals, said Chiang.

With respect to age related tinnitus one of the most recommended treatments being viagra uk without prescription . So no more worries of hair fall in these levitra professional countries. But now there are some effective medications available to increase the volume of corpus cavernosa, which are the structures in super active cialis the penis responsible for erection. cheap female viagra Past research has shown that a high number of traffic; needless to say, if they accept the severity, they do not actually seek for help. The Canbridge investment marks its third deal financing a biotech start-up with Qingming Partners, both of which supported promising biotech start-ups Zai Labs Inc. and Ark Biosciences Inc., both of Shanghai. (See BioWorld Asia, June 24, 2014, and Sept. 2, 2014.) Qingming Partners is also an investor in Tigermed.

Because the limited partners in TF Capital come from the health care industry, Chiang explained, the fund has a longer life cycle than many other funds, with a horizon of eight years plus a three-year extension.

Chinese VCs typically have five years plus two, making it difficult for many to invest in early stage biotech companies.

It also helps that the Canbridge investment comes at the beginning of TF Capital’s life cycle, which allows the venture firm to stay for the “long haul,” according to Chiang.

With so many industry contacts, “we believe that we have more information and connection to understand the risk better than most of the investment companies in the industry,” Chiang said. But he added, “the investment cycle is long so it is better [to] work with friends who have the appetite for risk.”

CHANGING REGULATORY LANDSCAPE

One of the risks is the quickly changing regulatory landscape. Xue intends to file the phase II trial for ATI-1123 as a multiregional clinical trial, or MRCT, the rules for which are going through a process of clarification. (See BioWorld Asia, Dec. 5, 2014.)

But Xue said he welcomes the government reforms as a way to help get more differentiated products on the market that offer greater value to patients. He said he has made a close read of the MRCT discussion document and is not expecting delays.

“People believe [the MRCT rules] will slow down regulatory approval. I don’t anticipate it will slow us down very much for the Azaya or Canbridge program – our MRCT is a true MRCT – vs. some other companies who may put the program under the cover of the MRCT,” he said. “We are going to file CFDA guidance as a MRCT phase II using the same protocol as our partners.”

As for T.F. Capital’s Chiang, he said he is happy to be working with Xue, who has both the scientific background and proven business experience, having set up the Genzyme China office.

He said the past year, with China’s enormous success in the internet and high-tech sectors, such as the listing of Jack Ma’s Alibaba Group for $24 billion, the biggest initial public offering (IPO) listing in history, has emboldened many of China’s best and brightest to become entrepreneurs. They are leaving cushy corporate jobs in droves to take a chance on China’s reforming economy that is growing the buying power of its middle class.

“The passion and the ego to be an entrepreneur in China is at an all-time high,” Chiang said. “You see all these success stories from the internet world now influencing pharma.”

“It is a different story now,” he added. “Everyone used to want to work for a company like McKinsey; now people are going out on their own, if they don’t, they feel they will regret it.”

That does not make finding an exit any more reliable, but it does help to find new investments.

The hope is that the IPO rules will change in the time frame of TF Capital’s investment, and Chiang added that “the challenge is finding the good people among ourselves and investors who have been in the industry for a long time, that we have a comfort level with. The exit is still challenging, but it is more friendly [amongst VCs]; so far, we feel comfortable, and there is the possibility of more exits opening up in the future.”

Posted on

How Chinese healthcare VC firm TF Capital is investing first fund

BIOCENTURY

14 WEEK OF December 8, 2014

EMERGING COMPANIES

How Chinese healthcare VC firm TF Capital is investing first fund

FAST FUNDING FOR CHINESE HEALTHCARE INNOVATORS

http://www.biocentury.com/biotech-pharma-news/finance/2014-12-08/how-chinese-healthcare-vc-firm-tf-capital-is-investing-first-fund-a13b

TF Capital plans to invest its inaugural China-focused VC fund in innovation and technology in that nation’s healthcare space. The firm, which has about $50 million to invest, has already made about eight investments, including last week’s $10 million series A round for in-licensing play

Canbridge Life Sciences Ltd.

 

“The whole healthcare sector has changed with the booming middle class, and we see a big

opportunity here,” said TF Capital’s Kevin Chiang.

The firm’s investors include CRO Hangzhou Tigermed Consulting Co. Ltd. (SZSE:300347) and specialty pharma Coland Holdings Ltd. (GreTai:4144), along with VC Qiming Venture Partners.

TF is investing up to $4 million per company and will invest its first fund in about 10-15 companies, including in-licensors as well as novel therapeutic plays and medtech.

So they viagra india price hired 58 women students and determined their BMI (Body Mass Index). There were many treatments suggested to people earlier but none of levitra free samples them truly succeeded and none of them fixed them. viagra generika Consequently, the smooth flow of blood makes one perfect in any parts of our body. Regular use of this herbal supplement offers lot 100mg viagra price of health benefits like enhanced blood circulation, renewed hair growth, eliminates erectile dysfunction, ensures glowing and youthful looking skin, and boosts sex drive.  

“The fund is focusing on and encouraging more early stage stuff than other funds in China,” said Chiang. He added that it has a duration of eight years, plus or minus two years.

According to Chiang, TF is investing the fund at a faster pace than expected and “very soon will have to raise a second one,” but he declined to disclose a timeline.

 

TF’s latest investment was last week’s Canbridge deal in which Qiming also participated.

Canbridge CEO James Xue said the company plans to use the funds for R&D for its two in-licensed programs and to add specialty care assets.

 

Early next year, CANbridge plans to file clinical trial application in China on phase II study of ATI-1123 in non-small cell lung cancer and will initiate CFDA registration process with Caphosol, an adjunct treatment for chemo and radiation induced oral mucositis.

Canbridge has rights in China, Taiwan and South Korea to ATI-1123, a protein-stabilized nanoparticle formulation of docetaxel, from Azaya Therapeutics Inc.; and rights from Jazz Pharmaceuticals plc (NASDAQ:JAZZ) to Caphosol in China and parts of North Asia.

TF and Qiming are also investors in Zai Laboratory Inc., another China-based in-licensing play.

Zai raised $32 million in an A round in September (see BioCentury, Sept. 22, 2014).

— Jennifer Rhodes