Deals and Financings

Hanmi Pharma (KRX: 1289400) of South Korea announced another blockbuster out-licensing deal for one of its clinical stage assets. This time, Janssen agreed to a $960 million deal in exchange for exclusive worldwide rights (except Korea and China) to a novel biologic GLP-1/Glucagon dual receptor agonist aimed at diabetes and obesity (see story). The molecule, HM12525A, is expected to begin Phase II trials next year. Last week, Sanofi (NYSE: SNY) agreed to pay as much as $4.2 billion for three Hanmi long-acting diabetes drugs. Previously, the company out-licensed a novel lung cancer therapeutic to Boehringer Ingelheim for $730 million and sold the rights for an autoimmune drug to Lilly (NYSE: LLY) for $690 million. 

LEO Pharma A/S, a Danish dermatological company, paid $727 million to acquire global rights to the dermatology assets of Japan's Astellas Pharma (see story). LEO said the acquisition, which is the largest transaction in its 100-year history, will add 20% to revenues. Among other benefits, the acquisition will increase LEO's presence in China and Russia. Before the transaction, LEO was already the largest MNC focused exclusively on dermatology products in China and number four in derm products overall. 

Medtronic PLC (NYSE: MDT), a global medical device maker, has partnered with Sequoia Capital to establish a $60 million joint investment fund, which will invest in healthcare technology startups aimed at China's market (see story). Suzhou BioBay joined as a limited and strategic partner. The ideal investment candidate will be a new China company with the potential to succeed in global markets. Ex-China companies that are developing products suited for the China market will also be considered.

BioDuro, a China-US CRO, has merged its US operations with Formex, an API formulation, development and cGMP manufacturing company located in San Diego (see story). Both companies are owned by Bridgewest Group of San Diego. In July, Bridgewest bought BioDuro from PPD, a global CRO. Masood Tayebi, PhD, who is a Partner and CEO of Bridgewest, founded BioDuro in 2005, sold it to PPD in 2012, re-acquired the company, and now he has merged Formex, another Bridgewest biopharma investment, into BioDuro. 

WuXi PharmaTech (NYSE: WX) and Eli Lilly will collaborate on China development of a novel, once-daily oral agent, discovered by Lilly and aimed at alleviating cardiovascular risk in patients with dyslipidemia (see story). The drug candidate is designed to reduce cardiovascular events in patients with elevated LDL cholesterol and triglycerides who are at risk for heart attacks or strokes. WuXi will be responsible for regulatory, development and manufacturing activities in China, while Lilly will market the drug. Both companies will invest in the project. 

ASLAN Pharma, a Singapore-based cancer company, will collaborate with Hyundai Pharm Co. to develop and commercialize ASLAN001 for cholangiocarcinoma (CCA) in South Korea (see story). ASLAN001 is a small molecule pan-HER inhibitor that targets CCA, an aggressive form of bile duct cancer with no approved therapy. Hyandai will also have first negotiation rights on ASLAN001 as a treatment for gastric and breast cancer in South Korea. The two companies will collaborate on clinical trials for the molecule, and ASLAN will retain co-marketing rights in South Korea. 

Government and Regulatory

After a four-month suspension, China will once again allow IPOs, the government announced (see story). The halt in initial offerings was meant to stop the June-July decline in China stock prices by preventing investors from selling old holdings to buy new ones. The decline did stop -- in August -- and now market indexes are up 12% since the beginning of 2015. There were 28 companies queued to IPO at the time of the halt. All of them may debut before the end of the year. Initially, ten companies will IPO, including at least one pharma company: Jiangxi Fushine Pharma. 

Company News

Cellular Biomedicine (NSDQ: CBMG), a China-US cell therapy company, officially opened a GMP manufacturing facility in the PKUCare Industrial Park of Beijing (see story). CBMG is developing stem cell products for joint and autoimmune disorders, and earlier this year, the company in-licensed CAR-T immuno-oncology technology from the Chinese PLA General Hospital (the 301 hospital) of Beijing. CBMG is headquartered in Cupertino, California, but China is its primary market. The new facility in Beijing adds capacity to CBMG's existing plants in WuXi and Shanghai. 

Trials and Approvals

Hutchison MediPharma (AIM: HCM), the drug development arm of Hutchison China MediTech, has started a US Phase I clinical trial of sulfatinib (HMPL-012) (see story). The trial will be a dose escalation study in US patients with solid tumors. In China, HMP plans to start a Phase III trial of HMPL-012 to treat neuroendocrine tumors and a Phase Ib study to treat thyroid cancer before the end of 2015. Although HMP has partnered many of its clinical stage candidates, it retains all rights to sulfatinib.