Deals and Financings
A China real estate developer and several China investment funds will spend $1.5 billion to develop a major biopharma site in South San Francisco, a project that will focus on fostering China-US cooperation in life sciences. The Oyster Point site was acquired by Greenland Holdings, a state-backed developer, plus Agile Group, Ping An Trust and Poly Sino Capital. When fully developed, the site could support over 2.2 million feet of office space, which is expected to be devoted entirely to life science companies.
Huapont Life Sciences (SHA: 002004) of Chongqing made a $6 million investment in Histogen, a San Diego company that is developing a stem cell treatment for hair loss. Huapont’s investment will anchor Histogen’s planned $18 million Series D funding. In return, Huapont will help Histogen develop its Hair Stimulating Complex (HSC), an injectable product based on cultured skin cells, in China. So far, HSC has shown efficacy in two US clinical trials.
Hunan China Sun Pharmaceutical Machinery (SHZ: 300216) completed a $2 million investment in Glucovation, a San Diego-area medical device maker. Glucovation is developing a novel, low-cost Continuous Glucose Monitoring device that provides blood sugar readings on a phone, pad or watch. In return for its investment, China Sun now owns a 20% stake in Glucovation, and the two companies will establish a JV for production of Glucovation’s device.
Hangzhou Cognitive Care has teamed up with IBM to provide IBM’s “Watson for Oncology,” a supercomputer program, to 21 China hospitals. Based on best practices, Watson for Oncology will suggest optimized individualized treatments for cancer. The program will synthesize patient records and medical literature. Hangzhou Cognitive Care, which will provide translation services, sales and customer support, said the agreement is the first use of the Watson for Oncology program in China.
The Shenzhen IPO of Jafron Biomedical, a medical device maker, created a new billionaire, Fan Dong, the company’s Chairman who owns a 48% stake in the company. Jafron raised $69 million in its IPO. Since the debut, the company’s stock has more than tripled, and Dong’s holdings are worth $1.1 billion. Jafron makes disposable cartridges that purify the blood and are used mainly as an adjunct to hemodialysis. The company is headquartered in Zhuhai, Guangdong Province.
Berry Genomics of Beijing and San Diego’s BioNano Genomics agreed to co-develop a next-generation mapping (NGM) system that will provide cost-effective, easy-to-use assays for detection of chromosomal structural variations in China. The assays will be built on BioNano’s Irys® instrument, an NGM platform. The new assays and instrument system will be validated in China clinical settings and submitted to the CFDA for registration review as a medical device.
Trials and Approvals
BeiGene (NASDAQ:BGNE), a Beijing oncology biopharma, received approval from the CFDA to begin China trials of BGB-290, a PARP1/2 inhibitor. Trials of BGB-290 are already underway in Australia and the US. BeiGene believes BGB-290 will prove to be a more selective inhibitor of PARP 1/2 than its competitors, decreasing the side effects and increasing efficacy, in patients with solid tumors. BeiGene also pointed out that BGB-290 is the third of the company’s programs to be approved for China trials.
Ambrx, a San Diego-China biopharma, will start US clinical trials of ARX78, an antibody drug conjugate targeting HER2. Earlier this year, Ambrx started an Australia-New Zealand trial of the candidate, and China tests are planned. Ambrx, which out-licensed China rights for ARX78 to Zhejiang Medicine (SHA: 600216) in 2013, expects ARX788 will be more effective for more indications than Roche’s (OTCQX:RHHBY) Herceptin. In 2015 Ambrx was acquired by a consortium of China companies, including Fosun Pharma (SHA: 600196; HK: 02196) and WuXi AppTec plus China equity investors HOPU and Everbright.
Ark Biosciences, a Shanghai biopharma located in Zhangjiang Hi-Tec Park, has begun dosing patients in a global Phase II trial of AK0529, a novel treatment for respiratory syncytial virus (RSV). RSV is a common infection among infants, and although usually not serious, it is the leading cause of hospitalization in infants under the age of one. Ark in-licensed global rights to ARK0529 from Roche two years ago. In its Phase I trial, conducted in Australia, ARK0529 was well tolerated with predictable pharmacokinetics.
Government and Regulatory
China’s FDA has released a draft of new rules that require drugmakers to self-report any changes to drug manufacturing procedures, followed by studies that show the drug’s efficacy is not harmed by the changes. The self-reporting is similar to CFDA rules issued last year asking drugmakers to self-report any errors in submitted clinical trial data. If the CFDA finds unreported changes in manufacturing procedures, it will consider the product a counterfeit drug, with corresponding penalties.
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