Lupin forms JV with Japan's Yoshindo Inc

The new entity will be responsible for conducting clinical development , including regulatory filings and obtaining marketing authorisations in Japan

Pharma major Lupin Limited has entered into a strategic joint venture agreement with Japanese pharmaceuticals company, Yoshindo Inc. to create a new entity, YL Biologics (YLB). YLB will be responsible for conducting clinical development of certain biosimilars including regulatory filings and obtaining marketing authorisations in Japan.

The new entity YLB will in-license Monoclonal Antibodies (mAbs) from Lupin and also partner with other companies across the globe for the Japanese market which already has a clear cut regulatory regime in place for the development and commercialization of biologicals, stated a company release.

The Japanese biological market is currently valued at close to $12 billion and growing at 2-3% annually. mAbs make up $3.5 billion of the overall Japanese biological sales and growing at 5 % (IMS Health).

Lupin's etanercept biosimilar will be the first product to be licensed for clinical development to YLB. Etanercept (Enbrel) is a biopharmaceutical product for treating autoimmune diseases such as rheumatoid arthritis, psoriasis and ankylosing spondylitis. Enbrel is marketed in Japan by Takeda Pharmaceutical and had sales of $496 million.

Lupin will be entitled to milestone based licensing income in addition to commercial supplies of the drug substance. Both Lupin and Yoshindo will then market the product under their own brand names by leveraging their respective sales networks, added the statement.

Kamal K Sharma, Vice Chairman, Lupin Limited said, "We are very excited about the joint venture with Yoshindo, a partner who shares our commitment to bringing biosimilars to market in Japan. YLB is a reflection of Lupin's long-term commitment to the Japanese market and is an important first step forward to establishing Lupin's global Biosimilar portfolio".

Lupin's shares were trading at Rs 989.10 apiece on the BSE, up 0.71% from its previous close.