China's Bio-Thera Solutions Partners with Cipla to Market Key Cancer Biosimilar
14 January 2019 - - Chinese biotechnology company Bio-Thera Solutions Ltd has reached a licensing agreement with Indian pharmaceutical company Cipla Ltd. (BSE: 500087) (NSE: CIPLA EQ) for BAT1706, its bevacizumab biosimilar, under which Cipla will have exclusive rights to distribute and market the drug in select emerging markets, the company said.

BAT-1706 is a mAb biosimilar to US-based Genentech's Avastin which is currently approved for six indications including metastatic colorectal cancer, recurrent glioblastoma and non-squamous non-small cell lung cancer.

Bio-Thera's BAT-1706 is currently in a global Phase III study (NCT03329911) in patients with previously untreated advanced non-squamous non-small cell lung cancer.

Bio-Thera said it plans to file for regulatory approval with the China National Medical Products Administration, the European Medicines Agency and the United States Food and Drug Administration (USFDA) in 2020.

This partnership will leverage Cipla's strong local presence, sales and marketing capabilities in the select emerging markets. Bio-Thera will be responsible for full development, product registration with the FDA and EMA, and commercial supply of BAT1706 out of its manufacturing facilities in Guangzhou, China.

Bio-Thera Solutions is a global biotechnology company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular diseases, and other serious unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases.

A leader in next generation antibody discovery and engineering, the company has advanced five candidates into late stage clinical trials and has applied for marketing authorisation for one candidate.

In addition, the company has multiple promising candidates in early clinical trials and IND-enabling studies, focusing on innovative targets in immuno-oncology and autoimmune diseases.

Established in 1935, Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics, and deepening portfolio in its home markets of India, South Africa, North America, and key regulated and emerging markets.

The company's strengths are in the respiratory, anti-retroviral, urology, cardiology and CNS segments. Its 44 manufacturing sites around the world produce 50+ dosage forms and 1,500+ products using cutting-edge technology platforms to cater to our 80+ markets.