Deals and Financings

ZAI Lab Limited, a novel drug development company located in Shanghai, broke out of stealth mode by announcing a major deal: the company has obtained global rights for two novel compounds from Sanofi (NYSE: SNY), both of which are potential treatments for chronic respiratory diseases (see story). ZAI is led by Dr. Samantha Du, who founded the company and serves as CEO. For ten years, Dr. Du was CEO of Hutchinson MediPharma, one of China’s very first innovative drug development companies. Since 2012, Dr. Du has been a Venture Partner at Sequoia Capital China.

Miraculins (TVE: MOM), a Canadian diagnostics company, finalized an agreement for China distribution of its Scout DS® Non-Invasive Diabetes Screening Device (see story). The device will be imported by Catalyn Medical Technologies Limited, a privately-owned Hong Kong company, and distributed by Cachet Pharma (SHE: 002462) of China. Cachet agreed to buy $90 million of the device over the five-year life of the contract. Miraculins will be responsible for obtaining CFDA approval of the device.

TNI BioTech (OTC: TNIB) of Florida expanded its relationship with Hubei Qianjiang Pharma (SHA: 600568) by signing an agreement that will speed up development of IRT-101 (MENK) (see story). TNI discovered MENK, an immunotherapy for cancer and autoimmune diseases. In 2012, Qianjiang in-licensed China rights to the drug. According to TNI, the partnership combines the drug development expertise of its subsidiary Cytocom, with Qianjiang’s financial, manufacturing and distribution capabilities.

Company News

On Monday, August 18, Dr. William Cao, CEO of Cellular Biomedicine Group (NSDQ: CBMG), will ring the closing bell at NASDAQ to celebrate CBMG's recent listing on the exchange (see story).  CBMG is a US-headquartered biotech that is developing new treatments for degenerative diseases and cancer in China. The NASDAQ event caps a busy two months for CBMG. During that time, the company reported positive data from a trial of its knee arthritis treatment, jettisoned its consulting business, raised $10 million in a private placement, paid $23 million to acquire a China cellular products company – and the company's stock price rose from below $6 to $23. http://www.chinabiotoday.com/articles/20140815

Stryker (NYSE: SYK), a US medical device maker, plans to introduce products from its China Trauson division into India in 2015 (see story). From there, Stryker plans to expand further into other Asian countries. In January 2013, Stryker paid $764 million to acquire Trauson, a company that makes trauma and spine reconstruction products. Stryker’s China revenues were up double-digits in the most recent quarter, and the company’s CEO said Trauson’s products, which address lower price points than Stryker’s, represent new business to Stryker.

Trials and Approvals

Celltrion (KOSDAQ: 068270), a Korean biotech, filed with the FDA for approval of Remsima®, a biosimilar to Janssen’s Remicade, which is indicated for autoimmune diseases (see story). Remsima is the first monoclonal antibody to seek approval in the US under the 351(k) rules for biosimilars. In 2009, Celltrion and Hospira (NYSE: HSP) agreed to become co-exclusive distributors of Remsima as part of a package of eight biosimilars (now expanded to eleven) under development at Celltrion.

Pfizer (NYSE: PFE) reported mixed results from two China trials of Lyrica®, an anti-seizure drug that is also effective against some forms of neuropathic and chronic pain (see story). Lyrica successfully reduced pain in a Phase IV follow-up study of patients with postherpetic neuralgia, the pain that follows shingles. But Lyrica did not meet its endpoints in a Phase III trial among patients with painful diabetic peripheral neuropathy.

Disclosure: none.