China Biotech in Review: New Cross-Border Clinical Trial

by: ChinaBio Today

Last week, there was news from the world of China life science of a prospective cross-border clinical trial. Also during the week, China life science reported progress in other areas: new deals were announced, expanded facilities were opened, one company reported its Q2 financials, and an early report was issued on a swine flu vaccine.

Access Pharmaceuticals (OTCQB:ACCP-OLD) of Texas revealed plans for a clinical trial of its solid tumor cancer drug, ProLindac, in China (see story). The trial will be conducted by Access Pharma’s China partner, Aosaikang Medicinal Group (ASK), a company that is also responsible for manufacturing scale-up of ProLindac. Access plans to use the China trial, along with a similar one conducted in South Korea by JCOM of Seoul, to help gain regulatory approval of ProLindac in the US and Europe. For its part, ASK is seeking to gain regulatory approval of the cancer drug in China.

Shanghai ChemPartner and ELARA Pharmaceuticals, a German company, will extend their drug discovery collaboration to include DMPK, pharmacology and toxicology for ELARA's lead oncology programs (see story). The two companies will jointly design and execute a drug screening cascade for ELARA’s Hypoxia Signaling inhibitor program. ChemPartner’s work has already helped move the program from academic discovery stage to early proof of concept.

AlphaRx [OTCBB: ALRX] released details of its recently announced China collaboration with Venturepharm (see story). AlphaRx, a company that adds its proprietary drug delivery technology to established pharmaceuticals, will establish an R&D facility inside of Venturepharm’s preclinical development facility, which is located in Taizhou’s China Medical City. For AlphaRx, the goal is to develop products for the China market.

Commonwealth Biotechnologies (CBTE) is struggling to prevent its delisting as it works toward completing an acquisition of peptide maker GL Biochem of Shanghai, a deal the company calls “transformative” (see story). In early June, CBI announced it would issue 6.6 million shares of its common stock to acquire GL Biochem. CBI expects $3 million of net income from $18 million of sales as GL Biochem’s business model expands.

China Sky One Medical (NSDQ: CSKI) is considering raising funds to finance acquisitions (see story). The company’s primary goal will be to acquire new products, instead of whole brands or entire companies, according to CEO Liu Yanqing, who was quoted in a Reuters article. Liu said the timing for the move seems right. Improved optimism in stock markets has made it feasible to raise funds, while China’s huge healthcare expansion will increase demand for drugs, he said.

Shanghai Biochip has discovered a new use for its genetic test technology. The company has developed a genetic test that analyzes the strengths and weaknesses of a child’s personality (see story). With a sample gleaned from a simple swipe of a cotton swab in the child’s cheek, the company can run a test of 11 basic personality-related genes. Those genes determine whether the child possesses the genetic predisposition for above-average intelligence, musical ability, athletic skill or other traits. Shanghai Biochip claims its results are 99% accurate.

Lonza Group, a chemical and biotech company headquartered in Switzerland, continued its China expansion by completing the start-up of the second phase of its large-scale API facility in Nansha, a district of Guangzhou (see story). The facility combines development services and cGMP chemical manufacturing. The new plant also includes facilities for administration, R&D, a kilo lab, and both small- and large-scale production. Seventy scientists provide R&D services in 1,000 square meters of lab space.

American Oriental Bioengineering (NYSE: AOB) reported higher Q2 revenues, though the company’s improved sales did not translate to the bottom line (see story). American Oriental’s revenues rose 21% in the period to $71.2 million, but net income slipped 5% lower to $13.2 million. AOB also announced a new product for rhinitis and allergies, Jingwei Capsules, which it compared to Schering-Plough's Claritine.

Sinovac Biotech (NASDAQ:SVA) released an early report from the clinical trial of its A/H1N1 influenza vaccine, announcing that no severe adverse reactions were observed following the first inoculation (see story). Participants experienced an 11.8% rate of adverse reactions. That is approximately equal to the average vaccine reaction and consisted mainly of pain at the injection site. Sinovac remains on track to start production of the vaccine in September, if all goes well with the trial.

Disclosure: none.