China Biotech in Review: New AIDS Vaccine Grabs the Spotlight

Nothing changes perceptions like an attention-grabbing headline. Last week, news came that an AIDS vaccine, developed by a team of China scientists, produced “good” results in its Phase I trial (see story). In this case, the unassuming word “good” means the vaccine performed better than other experimental AIDS vaccines in their Phase I tests. The scientific team, aware of the daunting Phase II and III trials still ahead, is being cautious before claiming complete success for the vaccine. For the part of the world still stuck in thinking China biopharma is exclusively devoted to generic versions of western drugs, the announcement shows that China biopharma is at the forefront of this particular unmet issue of public health. The scientific team developing the vaccine is led by Prof. Shao Yiming, head of China's National Center for Disease Control and Prevention. The vaccine itself employs a unique mechanism. Using a smallpox vaccine as a carrier, the HIV virus gene is inserted into the vaccine. The vaccine has a replicative vector, which kills the HIV virus by replicating the attenuated HIV gene. The vaccine has already begun its Phase II trial, and we all wish them success.

Meanwhile, last week also saw the announcement of new deals among China biopharma companies, as they continue to consolidate entities and expand their business plans. Tigermed Consulting, a CRO with a clinical trial focus, established a subsidiary, Hunan Tigermed Xiangya Drug R&D Ltd. (see story). The subsidiary will augment Tigermed’s services in the pre-clinical and Phase I areas. A collaboration with Central South University (CSU), Tigermed Xiangya will give the company a Phase I Clinical Laboratory. Services will include, among others, pharmacokinetics (PK), pharmacodynamics (PD) and bioequiavailability (BE) studies.

Erye Pharmaceutical Co. of Suzhou tightened its relationship with NeoStem, Inc. (NBS) when principals of Eyre invested $500,000 in a private market financing of NeoStem (see story). The investors paid $1.25 per unit; each unit includes one share of NeoStem and one warrant to purchase an additional share at $1.75. NeoStem ended the trading session at $.91, lower by one cent. In November, NeoStem agreed to acquire a 51% stake in Eyre Pharma. NeoStem is in the business of collecting and storing adult stem cells for future medical need. In addition, NeoStem owns an exclusive license to technology to identify and isolate very small embryonic-like stem cells (VSELs), which seem to have many of the same properties as embryonic stem cells.

In new-product news, China Sky One Medical (CSKI) reported that its wholly-owned subsidiary, Heilongjiang Tianlong Pharmaceutical, obtained SFDA production approval for a TCM-based nasal drop that treats allergic rhinitis and sinusitis (see story). According to China Sky One, the TCM formula produces fewer side effects than its competitors, which contain chemicals or hormones. China Sky One predicts the nasal drops will add about $3 million to 2009 revenues. Although four other China companies have production licenses for a similar product, they do not have a distribution network comparable to China Sky One’s. For that reason, the other manufacturers do not market their TCM-based nasal drops, and China Sky One expects to have an exclusive product.

AnaSpec, a San Jose, CA company that supplies proteomics research tools to the drug industry, signed a second a non-exclusive China distribution agreement in as many weeks, this one with Yope Biotechnology (see story). The first agreement was with Shanghai Universal Biotech. Both companies will distribute AnaSpec’s custom and catalog products in China. Yope already markets a portfolio of antibodies, ELISA Kits and recombinant proteins. AnaSpec’s products, which are concentrated in three technologies: peptides, detection reagents, and combinatorial chemistry, will add to Yope’s portfolio. AnaSpec, which appears to be expanding rapidly in Asia, also recently signed a distribution agreement with Biogenuix Medsystems Pvt. Ltd., which will distribute AnaSpec’s products in India.

On the negative side of the news, the effects of the worldwide economic crisis spilled over into a China CRO. WuXi PharmaTech (WX) discontinued its US-based biologics manufacturing business, which is currently operating out of its Philadelphia facility (see story). The operation was part of WuXi’s controversial AppTec acquisition, completed earlier this year. In a conference call, WuXi management said the dynamics of the business have changed dramatically in the last three to six months. Small biologic pharmas, who were the only clients of the service, are facing critical funding problems because of the worldwide economic slowdown. As a result, many of them are not moving forward with the small-scale manufacturing of drug candidates for clinical trials. The client base for biologic manufacturing comprised just 20 small biotechs, as opposed to WuXi’s CRO business, which has 200 clients.

Another setback for China biopharma came to light when Sinovac Biotech Ltd. (SVA) reported that a two-year-old infant died two days after receiving the company’s flagship product, the hepatitis A vaccine Healive (see story). As a result, sales of the vaccine were suspended in Beijing's Fengtai district. Later, Sinovac said the Health Services Bureau of Fengtai District in Beijing suspended the use of just 83 doses of the drug, and the side effects are limited to a single individual so far. The vaccine has been in widespread use for years. The suspended vaccine came from lot 2008052105, of which 19,850 doses have been distributed. The lot passed routine government safety inspections in July 2008.

Disclosure: none.

Comments

[SA Editor M...:]

This note from Patrick G. via email:
This article discusses a Chinese effort to come up with a cure for AIDS. My concern is that your web site reported this as if they were the ones to come up with the Vaccine they are currently testing. Unfortunately, they are again copying something being done in the United States by a company called Geovax. Geovax has begun their Phase 2 trials but no coverage has been given to them by your web site. Please look into Geovax (geovax.com), ticker symbol GOVX and see for yourself about what is happening.

2008 Dec 12 01:19 PM