Deals and Financings
Adagene Inc., a Suzhou antibody discovery and engineering company, closed an $8 million Series A round of financing with participation by two Fidelity funds -- Fidelity Biosciences and Fidelity Asia Growth -- along with the WuXi Venture Fund, the investment arm of WuXi PharmaTech (NYSE: WX) (see story). Adagene partners with other pharmas to develop antibodies for the partners' needs and is also building its own portfolio of products, which it will out-license later in their development.
Guangxi Wuzhou Pharmaceutical closed a $3 million investment in Integra Holdings. Integra is a biotechnology holdings company established by Yissum, the technology transfer arm of the Hebrew University of Jerusalem (see story). It boasts a portfolio of nine companies that range from pre-clinical stage to registered products. It is expected that Wuzhou will bring Integra products to China's market.
Cipla (BSE: 500087), an Indian generic pharma, sold its 48% stake in Jiangsu Cdymax Pharmaceuticals, an API company, for $18.5 million, which was the price Cipla paid for the stake two years ago (see story). The buyer was another shareholder in Cdymax. At the time of the original purchase, Cipla wanted to enter the API business, but its strategy has changed. The company said it wants to be in China by offering "affordable high quality products." Previously, Cipla announced a biosimilar project for China.
Luqa Pharmaceuticals of Hong Kong expanded its dermatology portfolio by in-licensing greater China rights to Reoxcare, an IP-protected dressing for hard-to-heal skin wounds, from Histocell, a Spanish biopharma. Reoxare is intended for chronic skin ulcers and traumatic or surgical wounds (see story). Luqa expects to launch Reoxcare in early 2015 in mainland China, Hong Kong and Macau, once it is approved. Financial details of the transaction were not disclosed.
Milestone Scientific (OTCQB: MLSS), a US medical device maker, signed an agreement for China marketing of its epidural instrument with its own minority owned JV, Milestone China (see story). Milestone Scientific owns 40% of the JV, and the JV's China executives own the remainder. Once the epidural device is approved by the CFDA, the JV has signed on to purchase at least 250 instruments in the first year, 550 in the second and 750 in the third.
Trials and Approvals
TWi Biotechnology, a subsidiary of Taiwan's TWi Pharmaceuticals, received permission to begin a Taiwan-US Phase II trial of a novel treatment for gout and high blood uric acid levels (see story). Both the US and Taiwan FDAs approved a protocol for the trial, which will test TWi's AC-201 controlled-release oral formulation of an Interleukin-1Beta inhibitor. TWi has already successfully completed a US-Taiwan Phase II trial of AC-201 among patients with type 2 diabetes.
BeyondSpring Pharmaceuticals, a clinical-stage cancer company, plans to start a China-US Phase III trial of its lead drug candidate, plinabulin, among patients with non-small cell lung cancer in Q1 of 2015 (see story). BeyondSpring, headquartered in New York City, is a virtual company. In plinabulin's Phase III trial, 75% of the patients will be enrolled in China and the remainder in the US.
BioChain, a US-China diagnostics company, announced CFDA approval of Epi proColon®, a non-invasive blood-based diagnostic test for colorectal cancer (see story). BioChain in-licensed China rights to Epi proColon from Epigenomics AG (F: ECX; OTCQX: EPGNY), a German-US company, in October 2013. The test was approved in only 14 months from the time of licensing, even though the process included a China clinical validation study.
Dan Zhang, MD, Chairman and CEO of China CRO Fountain Medical Development, says, "Everybody thinks about China. It’s up to our clients—you—to take quick action and not wait anymore. Start from small stakes, touch the market. After all, this is going to be the world's largest pharmaceutical market, so it pays for you to do something about it (see story)." Dr. Zhang looks at the China's drug development sector, its appeal, its growth drivers and its hurdles. Fountain Medical is a clinical CRO that offers Phase I-IV trials in China and East Asia to its international and domestic Chinese clients.
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