Deals and Financings

Eddingpharm, a China drug company known mostly for in-licensing China distribution rights, acquired all the assets of San Francisco-based ACT Biotech, including global ownership of three cancer-targeting small molecule drug candidates (see story). The most advanced of the three, Telatinib, completed a successful US Phase II trial in gastric cancer patients in 2011. It has been granted Orphan Drug status by the FDA. Total consideration for the deal, including upfront and milestone payments, may reach up to $95 million.

MicroPort Scientific (HK: 00853), a Shanghai medical device maker, announced it will form a $20 million JV with Italy’s Sorin Group (MIL: SRN) to provide cardiac rhythm management devices in China (see story). The JV will market Sorin’s CRM products in China and also develop China-made CRM products. MicroPort will invest $10.2 million for 51% of the JV and Sorin will add $9.8 million for the remaining 49%.

Kunshan RiboQuark Pharma, a siRNA joint venture formed by Suzhou Ribo Life Science and Quark Pharma of California, raised almost 45 million RMB ($7.5 million) in a series A round (see story). The financing was led by BVCF, formerly known as BioVeda China. RiboQuark will use the money to further clinical development of QPI-1007, a siRNA ocular neuroprotectant developed by Quark for which the JV owns China rights.

JHL Biotech, a Taiwan-China biotech, announced a collaboration with BioLineRx (NSDQ: BLRX; TASE: BLRX) of Israel to develop BL-9020, a novel monoclonal antibody that treats Type 1 diabetes (see story). JHL Biotech will be the global manufacturer of BL-9020 and also own rights to the drug in China and Southeast Asia. BioLineRx will have development and commercialization rights in the rest of the world.

Bayer HealthCare and Peking University of Beijing will collaborate on a three-year translational drug discovery project (see story). The focus will be on innovative products for cardiology, oncology, hematology, and gynecological disorders. The two partners will establish a joint research center at Peking University, and Bayer will provide funding for collaborative research projects.

Industry Insights

Asia’s growth in biopharma R&D is changing the global landscape. The US, once dominant, saw its share of global spending on biopharma R&D drop from 51% to 45% over the six years that stretched from 2007 to 2012, according to a study by the University of Michigan Health System (see story). Asia’s share rose from 18% to 24% during the same period.

Legal and IP Issues

China revoked Johnson & Johnson’s (NYSE: JNJ) trademark for its “OneTouch” diabetes glucose monitoring products (see story). Since 2007, J&J has been trying to convince China courts that Guilin Zhonghui Biotechnology has been producing counterfeit versions of its products under a similar name: “One Touch” (two words rather than J&J’s one). Now, the State Administration for Industry and Commerce has ruled that J&J does not have the right to trademark a phrase that was already in common use. J&J has vowed to appeal the ruling.

Trials and Approvals

Adimmune of Taiwan has completed a China Phase III trial of its trivalent flu vaccine in 1,200 people (see story). It expects CFDA approval in mid-2014, which will allow the company to market the vaccine in mainland China in time for the 2014-2015 flu season, making it the first Taiwanese company to provide a vaccine to China. Adimmune is the only GMP-certified vaccine maker in Taiwan.

TaiGen Biotechnology of Taiwan will launch its first product, a novel antibiotic, in China in the second half of 2014 (see story), according to the company’s Chairman and CEO, Ming-chu Hsu. Nemonoxacin is a treatment for pneumonia and skin infections. TaiGen sold China rights for nemonoxacin to Zhejiang Medicine Co. (SHA: 600216) in 2012 for $8 million upfront. Approval of the antibiotic in Taiwan should follow in 2015, said the company.

Government and Regulatory

China will institute an official blacklisting system of drugmakers and medical device manufacturers to punish them for bribing officials or providing substandard products (see story).  The system was announced by the National Health and Family Planning Commission recently. It will prevent a company from selling products in any province for two years where it has been found guilty of an infraction. If the company commits two infractions in a five-year period, it will be banned from selling its products anywhere in China, also for two years. The blacklist will officially begin operations on March 1.

Disclosure: none.