Mumbai-based Glenmark Pharmaceuticals has entered into an exclusive license agreement with biopharmaceutical firm Harbour BioMed to develop, manufacture and commercialise the former’s novel oncology molecule (GBR 1302) for China. The exclusive license agreement, potentially worth more than $120 million (around Rs 8.2 billion), in addition to royalties.
This would give access to the Greater China market (China, Hong Kong, Macau and Taiwan) to Glenmark where it is not present at the moment. As such there is a shortage of affordable oncology molecules in China and Indian drugmakers are working on plans to tap one of the largest regulated markets in the world.
“It is significant because Glenmark is probably the only Indian company to have done a deal with Chinese company for an innovative asset. Through this, Glenmark will indirectly get access into China, the second-largest pharmaceutical market in the world, and also get access to Chinese patient pool data. We continue to evaluate licensing opportunities for our innovative assets across markets,” a company spokesperson said.
GBR 1302 is a clinical stage molecule and Harbour BioMed will lead the clinical development and commercialisation of GBR 1302, with the option to manufacture GBR 1302 for the Greater China market. The companies will collaborate on the generation of clinical data to support the registration of GBR 1302 in their respective territories.
With a stringent regulatory environment in China, not many Indian companies have been able to conduct clinical trials in that market.
Glenmark said that it would receive an upfront payment and is eligible to receive payments for achieving pre-specified development, regulatory and commercialisation milestones, as well as tiered royalties on net sales for any approved products from Harbour BioMed.
“We are very pleased to begin this strategic relationship with Harbour BioMed for the development and commercialisation of our bispecific antibody, GBR 1302 in Greater China, where the predominance of certain HER2 positive cancers presents a significant clinical need,” Glenmark’s chairman and managing director Glenn Saldanha said.
Jingsong Wang, founder and CEO of Harbour BioMed said, “GBR 1302 is complementary to the internal portfolio we are building through our industry-leading transgenic mouse platforms for generating innovative antibody-based therapeutics.”
Glenmark has a pipeline of seven innovative molecules, which includes two new chemical entities, four new biological entities (three in oncology space, one in dermatology), and a biosimilar candidate, in various stages of clinical development, focused in the therapeutic areas of oncology, dermatology and respiratory.