According to a recently released Thomson Reuters report, China is the global leader of pharmaceutical innovation. The country is successful, Thomson Reuters believes, because it has fostered a healthy mix of partnerships, pharma industry innovation and scientific research. The research is carried out at institutes and fosters collaboration between the government and industry. During 2015, five of the top ten global organizations for filing pharma patents were located in China. Over the period 2005-2015, three of the top ten organizations (including top spot) for publishing papers about drugs and disease were China institutes.
WuXi AppTec considers partnerships a part of its overall product development capability, Dr. Hua Mu, SVP at WuXi told ChinaBio® Today in an exclusive interview. WuXi forms partnerships to advance product development for the partners and gain faster approval of the products in development for China, he said. The ChinaBio® Partnering Forum, which will be held May 18-19 in Suzhou has been important to WuXi and Dr. Mu. When he returned to China six years ago, he met colleagues from Lilly at a ChinaBio Partnering Forum. Since then, he has formed two partnerships with Lilly.
Deals and Financings
SciClone (NASDAQ:SCLN), a US pharma focused on the China market, in-licensed China rights to a solid tumor cancer drug from Spain's AbilityPharma in a deal potentially worth $20 million. ABTL0812 has completed a Phase I/Ib trial in Spain. In exchange for greater China rights to the drug, SciClone will make an upfront payment along with development, regulatory and sales milestones plus royalties. In Europe and the US, ABTL081 was given Organ Drug status for pediatric cancer neuroblastoma.
Taiwan's ACT Genomics, which provides genomic profiles for personalized cancer care, completed a $12.5 million Series B funding. ACT provides genomic profiling assays and next-gen sequencing for use by doctors and pharmas. The company offers targeted therapy treatment options, predictors of immune-checkpoint inhibitor response, and ctDNA-based assays to monitor tumor burden and resistance markers. The round was led by Hotung Group of Taiwan and CDIB Capital Management, the overseas investment arm of China Development Financial.
Harmony Biopharm, a Hong Kong company that in-licensed Asia rights to Dance Biopharm's inhaled insulin product, formed a JV with Dongbao Pharma to commercialize the product in China. The JV will be capitalized with $11 million. Dongbao, an insulin specialist, has deep knowledge of Dance's inhaled insulin product because it manufactures the product for Dance. Dance 501 is comprised of an inhaler and a liquid insulin formulation to keep the costs about the same as an insulin pen device.
YiChang HEC Changjiang Pharma (HK: 1558) out-licensed US rights for a generic insulin product to Lannett Company (NYSEMKT:LCI), a Philadelphia generic drugmaker. The insulin product is one of a five-drug package that Lannett has obtained. The other four were not disclosed, but according to YiChang HEC's website, it has five generic insulin products in development. Lannett will complete the US approval process for the insulin product. Financial details of the agreement were not disclosed.
Warburg Pincus, a US-based private equity firm, made an investment of undisclosed size in China's UIB, a chain of obstetrics, gynecology (OB/GYN) and pediatrics hospitals. Currently, UIB owns two operating hospitals with two more expected to complete construction this year. The investment was one of the first made from Warburg Pincus XII, a $13.4 billion global fund that closed last year. Warburg Pincus is also raising $2 billion for a China-specific fund.
Trials and Approvals
Hutchison China MediTech (Chi-Med) (NASDAQ:HCM) has fully enrolled a China Phase III trial of fruquintinib (HMPL-013) as a treatment for colorectal cancer. The trial enrolled 416 patients with locally advanced or metastatic disease who have previously received two previous rounds of treatment. Fruquintinib, which is also in a Phase III China trial for non-small cell lung cancer, targets VEGFR 1/2/3. Lilly (NYSE:LLY) in-licensed rights to the drug in 2013 in a deal worth $86 million plus royalties.
CASI Pharma (NASDAQ:CASI), a US-China biopharma, received CFDA approval to extend the US Phase II trial of its lead molecule (ENMD-2076) in fibrolamellar carcinoma into China. CASI is already testing ENMD-2076 in three additional US-China Phase II trials for other indications. ENMD-2076 is an oral Aurora A/angiogenic kinase inhibitor that slows cell division and inhibits formation of new blood vessels. Headquartered in Maryland with a lab in Beijing, CASI in-licenses products for the China market, but the company is developing ENMD-2076 globally.
AliHealth (HK: 0241), the online health service of Alibaba (NYSE:BABA), will offer an updated version of its drug tracking service this month. The previous version was shut down in February. The new service will be voluntary, offer low-cost entry and provide free authentication for consumers. The previous version was mandatory for pharmas, who complained about the expense and about AliHealth's dual role as regulator and future competitor. As the operator of the system, AliHealth could monitor China drug sales, giving their planned online pharma proprietary information about sales trends.
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