ScinoPharm and Lee’s Pharmaceutical announce execution of two collaboration agreements

The two parties will jointly develop and produce Fondaparinux, an anti-thrombotic agent and Travoprost and Bimatoprost, two prostaglandin derivative drugs for treating glaucoma. Capitalizing on the strengths and expertise of the two companies, the products are expected to offer competitive advantages upon entering into the Chinese high-end generic drug market.

These drugs have extremely high technical entry barriers in process development and manufacturing. This collaboration takes the advantages of the two sides, i.e., the R&D strengths of ScinoPharm in the development and manufacturing of highly potent APIs, coupled with Lee’s wealth of experience in developing and manufacturing ophthalmic products plus its outstanding marketing channels in China.

ScinoPharm president and CEO Dr Jo Shen noted that this collaboration signifies ScinoPharm’s strategic growth strategies in China by aggressively expanding its ‘Double A Strategy’, i.e., developing ANDA (Abbreviated New Drug Applications) for in-house developed APIs.

"It will be also helpful in triggering a formal on-site inspection by the China Food and Drug Administration (CFDA) of ScinoPharm’s new manufacturing and R&D Center in Changshu, Jiangsu. This will allow products produced at ScinoPharm Changshu plant to enter the Chinese market thus opening up a wide range of business opportunities related to high-end generic drugs," Dr Shen added.

Fondaparinux, the API and formulation developed by ScinoPharm and licensed to Lee’s, is an anticoagulant that helps prevent the formation of blood clots caused by orthopedic surgery of the lower limbs. The chemical reactions associated with this type of carbohydrate-based drug synthesis technology are extremely complicated, consisting of more than 50 chemical steps.

ScinoPharm is one of the few companies in the world with a complete technical and scaled-up material supply chain for this API. ScinoPharm will provide the API as well as the formulation technology to Lee’s exclusively and then authorizes Lee’s for the manufacture of the formulated product in China.

Lee’s will submit an application at CFDA for drug certification and expects it to become commercially available in 2018.

Two new generation prostaglandin derivatives, Travoprost and Bimatoprost, for glaucoma have shown good clinical results in terms of IOP-lowering effect, which can effectively prevent the deterioration of the condition.

ScinoPharm Changshu produces the APIs for these two drugs, which will be exclusively supplied to Lee’s for the development and production of formulations in China. Lee’s will also file their drug license applications with CFDA. Travoprost and Bimatoprost under this collaboration are expected to become commercially available in China by 2019.