Dive Brief:
- Harbour BioMed and Sichuan Kelun-Biotech Biopharmaceutical announced a partnership Sunday, giving Harbour the global rights to the Chinese biotech's PD-L1 inhibitor.
- Kelun-Biotech will retain manufacturing and licensing rights in China and receive upfront and milestone payments that could top $350 million, in addition to royalty payments. Kelun's checkpoint inhibitor A167 is in Phase 1 and 2 testing in China for lymphoma and solid tumors.
- The two biotechs will work together to advance A167 and find viable combination therapies as they look to join the recent wave of companies entering the checkpoint inhibitor market. Kelun-Biotech is based in the city of Chengdu, while Harbour is headquartered in Shanghai but has a presence in Boston.
Dive Insight:
Merck & Co.'s Keytruda (pembrolizumab) and Bristol-Myers Squibb's Opdivo (nivolumab) broke into the PD-1 space with approvals from the Food and Drug Administration in 2014. Since then, there's been furious competition from others vying to stake claims in the profitable space.
There are more than 150 anti-PD-1/L1 agents in development, with roughly 50 in clinical testing, according to a January report in the Annals of Oncology using data up to September 2017.
A litany of companies have also narrowed in on combo trials with the five agents already on the market. The oncology report found more than 1,000 ongoing combo trials with nearly half of those started just in 2017.
Harbour BioMed and Sichuan Kelun-Biotech will try to find their own niche in the checkpoint inhibitor market with A167. The companies said they are testing in lymphoma and solid tumors and signaled they will also look at combo studies. Notably, both Keytruda and Opdivo received FDA approvals in the past two years for Hodgkin lymphoma.
"A167 has significant potential as a single agent and as the foundation for combination therapy with other innovative drugs," Harbour CEO Jingsong Wang said in a statement. "We plan to conduct A167-based combination trials globally by ourselves, including with innovative compounds we are developing, or in collaboration with our partners, to find better therapeutic options against a wide range of tumor types."
The deal also highlights the shifting trends in the biotech space. Historically, few new drugs have come out of China, but that's rapidly changing. Kelun-Biotech is licensing away its international rights in a move similar to how American biotechs sometimes offload rest-of-world rights outside the U.S.
Kelun-Biotech, however, will keep the licensing and manufacturing rights in the Chinese market, making a bet on the future of China as a growing market for cancer drugs.
Harbour BioMed was established in 2016 with $50 million in funding. In January, it completed a Series A+ funding round without disclosing financial details.
Kelun-Biotech is one of more than 90 subsidiaries of the Sichuan Kelun Pharmaceutical Co., which trades on the Shenzhen Stock Exchange. The company has a market cap of roughly $5.5 billion in U.S. dollars.