Deals and Financings

BeiGene, a novel drug development company located in Beijing, raised $75 million in a series A funding (see story). BeiGene has three oncology drug candidates in Phase I testing, and it has sold ex-China rights for two of them to Merck Serono in deals that are worth as much as $232 million each. In addition, it secured a large (the exact amount was undisclosed) investment from the US pharma Merck (NYSE: MRK) in 2011. BeiGene has made substantial progress in its first four years: it is a remarkably mature company to be announcing its first VC fundraising round. 

Ascletis, a China-US novel drug developer, in-licensed China rights to a clinical-stage hepatitis C treatment from Presidio of San Francisco (see story). PPI-668 is an NS5A inhibitor currently in a Phase II trial in the US. Ascletis is also developing another treatment for HCV: a Roche (VIX: ROG) protease inhibitor known as danoprevir. Ascletis thinks the two drugs can be combined to combat HCV in an interferon-free regimen. 

BioAtla, a San Diego-China biotech, will collaborate with BioDuro to develop two therapeutic monoclonal antibodies in China (see story). BioDuro is a Shanghai CRO, owned by PPD, that provides BioAtla with lab services. The two companies will develop the two mAbs through preclinical work and a Phase I trial before licensing each one to a China biopharma. The disease targets were not disclosed. 

ScinoPharm (TWSE: 1789) of Taiwan and Nanjing King-friend Biochemical Pharmaceutical, a heparin API supplier, have teamed up to develop Regadenoson for China (see story). Developed by Astellas of Japan, Regadenoson is a coronary artery vasodilator, which is used in radionuclide myocardial perfusion imaging among patients who cannot tolerate exercise stress. Astellas has not applied for a China drug license for Regadenoson. 

Sinopharm (China National Pharmaceutical Group) and Provectus Biopharma (NYSE: PVCT) of the US have extended their MOU for another six months to May 16, 2015 (see story). During the first three months of the agreement, the two companies were not able to come to terms on China rights for Provectus's lead drug candidate: PV-10, a cancer immunotherapy. According to reports, Sinopharm will study the recently published protocol for the melanoma Phase III trial of PV-10 to "understand the drug better." 

Government and Regulatory

In a long-awaited move, China's Center for Drug Evaluation has published draft regulations for approval of biosimilar drugs (see story). The proposed rules offer the possibility of a shorter regulatory timeframe for this very important class of drugs, though the proposals, which are more like an overview than a how-to manual, are not specific. They do, however, establish a step-by-step procedure in which "no or little difference" in one test could mean fewer or smaller tests in subsequent steps, which seems to give regulators significant discretionary power. To be approved, a biosimilar must undergo a randomized, double-blind clinical trial to prove efficacy. 

Company News

WuXi PharmaTech (NYSE: WX) reported Q3 revenues were up 18% to $173.6 million, a record, while GAAP earnings were higher by a smaller 8% at $0.45 (see story). The company has "strong momentum," according to Dr. Ge Li, Chairman and CEO. To keep growing, it increased Capital Expenditures from $56 million last year to $100 million in 2014, and will spend even more next year to increase manufacturing capacity, WuXi's fastest growing business sector. And WuXi now has 500 employees devoted to biologic drug discovery, another major growth area. 

Trials and Approvals

CASI Pharma (NSDQ: CASI), a US-China cancer drug company formerly known as EntreMed, received CFDA permission to conduct a Phase II trial of its lead molecule, ENMD-2076, in soft tissue sarcoma patients (see story). It is the second indication in China for ENMD-2076, which was approved in July to begin a Phase II trial in patients with triple-net negative breast cancer. CASI has also filed to begin a trial of the drug in advanced ovarian clear cell carcinoma. All three are expansions of US trials. 

Disclosure: none.