Deals and Financings
Sinopharm, China's giant state-owned pharmaceutical company, paid $252 million to purchase a 57% stake in Winteam Pharmaceutical Group (HK: 0570). Winteam, whose headquarters are in Hong Kong, operates in mainland China. The company makes TCM preparations, western-style chemical drugs and biologics. The acquisition builds Sinopharm's portfolio, especially in the area of TCM drugs.
OrbiMed Advisors is raising money for its second Asia healthcare private equity fund, which will be invested mainly in China and India. In news reports this week, the target was pegged at $500 million, though sources close to OrbiMed said the company is seeking $300 million, the original goal rumored last fall. Whatever the ultimate amount turns out to be, Orbimed expects to close Asia Partners II later this year, just about the time it will have its $188 million Asia Partners I fund fully invested. OrbiMed, headquartered in the US, specializes in healthcare investments around the globe.
China Grand Pharma (HK: 00512) will form a JV with HuangShi Feiyun Pharma that will be capitalized with $20 million. China Grand Pharma will contribute $12 million while HuangShi Feiyun will purchase the remaining 40% with $8 million. HuangShi Feiyun is an oncology drug and anti-viral medicines company located in Hubei Province. Its products will be the basis of the new JV.
Fosun Pharma (SHA: 600196; HK: 2196) formed a China distribution JV with Atrium Innovations (OTC:ATBIF), a dietary supplement company headquartered in Canada (see story). Initially, the JV, which will be called Fosium Innovations, will import and sell Atrium's Pure Encapsulations® line of supplements in China. Atrium paid $1 million for a 49% share of the new JV; Fosun is contributing its distribution network and expertise. Over time, the two companies expect to bring additional Atrium products to China.
Crystal Pharmatech, a Suzhou CRO, will partner with Particle Sciences, a CRO based in New Jersey. The partnership will focus on solving the insoluability difficulties in new drug molecules. The partnership is the second that Crystal Pharma has formed in as many months. In January, Crystal and US-based Xceleron teamed up to collaborate on the pharmacokinetics of development-stage drugs.
Government and Regulatory
With the goal of encouraging innovation in both innovative drugs and generics, the SFDA has released new proposed guidelines for its drug review process. The most significant change will be a new emphasis on the clinical need for the drug. Drugs that address an unmet need - whether new or generic - will be given greater priority. In addition, the SFDA proposes greater emphasis on drugs for children and better protection for clinical trial participants. The SFDA aims to speed up approval for the products that address the most critical needs.
Polaris Group, a San Diego biotech with multinational collaborations, will build a $50 million drug manufacturing facility in Chengdu, the capital of Sichuan Province in Southwest China. Polaris is currently conducting a global Phase III trial of a biotech drug for hepatocellular cancer. Previously, Polaris intended to build the facility in Taiwan, which is the source of the company's startup capital. But Taiwanese land restriction policies proved too difficult, and Polaris decided to locate the facility in Chengdu instead.
Mindray Medical (NYSE: MR), the Shenzhen medical device maker, reported that 2012 was another record breaking year (see story). Revenues for the company totaled $1.06 billion - the first year its revenues topped $1 billion and an increase of 20% over 2011. Net income rose 14% to $212 million (non-GAAP). Much of the growth came from its domestic China sales: they were up 26%. In 2013, Mindray expects revenues will climb another 17%.
Trials and Approvals
Pfizer (NYSE: PFE) received China approval for Xalkori (crizotinib), an innovative treatment for patients with non-small cell lung cancer (NSCLC) that has the anaplastic lymphoma kinase (ALK) mutation (see story). The ALK-positive variation, which comprises between 3% and 5% of all NSCLC tumors, must be proved by a biomarker test. Pfizer said China's approval came just eleven months after it submitted a new drug application to the SFDA for Xalkori.