Late last week, Regenerx Pharmaceuticals (AMEX: RGN) was awarded a patent in China for its Thymosin beta 4 (TB4) investigational products for the indications of reversing or inhibiting eye degeneration associated with dry eye syndrome. This includes dry eye that is caused by surgical eye procedures such as LASIK and PRK. TB4 is a synthetic copy of a naturally occurring molecule that is identical across all species. It is a key regulator of actin, which is responsible for cell movement (for example, into a wound). Researchers from the Department of Biology, Shangdong University and the Peking Union Medical College in Beijing are verifying the therapeutic importance of TB4. To move the compound toward commercialization, Regenerx is conducting clinical trials of TB4 for dermal, ophthalmic and internal indications, but none of the trials are being carried out in China. The US granted a patent for TB4 in September.

In other China biopharma news last week, Tongjitang China Medicines (NYSE: TCM) reported positive results from a two-year, western-style clinical trial of its traditional Chinese medicine for osteoporosis, Xianling Gubao (see story). After six months of treatment, Xianling Gubao reduced bone resorption by 25% (the process of bone loss) and increased the bone density of the spine (the lumbar vertebrae L1) by up to 3.1%. Without Xianling Gubao, the density loss in bone can be as much as 2% per year. Tongjitang will use the data to support a request for FDA approval of Xianling Gubao, which Tongjitang believes is still three to five years in the future. Synarc, the US-based company that specializes in radiology and biochemical biomarker clinical trials, conducted the trial from its Beijing office. 

On the deal front, Benda Pharmaceuticals (OTCBB: BPMA), working through its China subsidiary SiBiono, formed a joint venture with DNAVEC to develop a gene-therapy based therapeutic vaccine for HIV (see story). DNAVEC chose Benda/SiBiono because the company already has a gene therapy therapeutic drug for cancer, Gendicine®, launched in China. Terms were not disclosed.

Another deal put something north of $30 million in the coffers of ShangPharma, a CRO based in Shanghai (see story). TPG, a private equity firm, made the investment, even though the deal did not conform with the firm’s usual MO of acquisitions and leveraged buyouts. A rumor surfaced that the investment was made to get ShangPharma to the position where it could make an IPO, taking advantage of the very warm afterglow fleft by the IPO of another China-based CRO, WuXi PharmaTech (NYSE: WX). One of ShangPharma’s divisions is devoted entirely to working on outsourced projects from Lilly (NYSE: LLY). 

Three major upgrades of facilities were announced last week. Novartis (NYSE: NVS) said it would make a major investment of $700 million to construct a biotech manufacturing facility in the Singapore’s Tuas Biomedical Park (see story). The plant will contain Novartis’ seventh – and largest – bioreactor worldwide. The new plant will be built next to a factory that produces tablet-form medications that opened last week. Much of Novartis’ Asian investments are in Singapore.

Roche (OTCBB: RHBBY) announced that it will spend $100 million to build a second R&D center in China (see story). The new facility will be the first fully functional China clinical drug R&D center that is owned by a multinational pharmaceutical company, one that is capable of taking a molecule all the way to commercial launch without help from ex-China expertise.

In the final improvement in facilities, international CRO MDS Pharma Services (NYSE: MDZ) moved to a larger lab in Beijing (see story). A 25,000 square foot space, it increases testing space by a factor of five and the space for producing clinical trial kits by a factor of four. MDS boasts that it has been in China for ten years, and was the first western CRO to own its testing facility there. 

In other business, Dragon Pharmaceutical Inc. (OTCBB: DRUG) announced that it has developed a new biotech production process for 7-ACA, an intermediate for Cephalosporin antibiotics (see story). The new process should reduce costs by reducing toxic byproducts that are expensive to treat. As a look at Dragon’s financials shows, the company has decent revenues but almost no profit, so lower costs would be welcome.


And finally, we look at the bill that re-authorized the FDA in the US, a bill that – sadly – sidestepped the political minefield of follow-on biologics (FOBs) (see story). More particularly, the US needs to decide the proper process for approving FOBs, once the patent protection on a biologic drug expires. This is vitally important to American consumers, who pay the most of any consumers in the world for drugs, but also for China biopharma, as companies like 3SBio (NDSQ: SSRX) are already marketing copies of American biologic drugs in China, but are prevented from applying for permission to market them in the US. We look at the chances for change in FOBs. More details…


Disclosure: none.