Newly founded Lianbio, with offices in Shanghai and San Francisco, aims to quickly establish a presence in China and Asia with late-stage assets in-licensed from Bridgebio Pharma Inc. and Myokardia Inc. in two deals amounting to $531.5 million and $187.5 million, respectively.

“Our mining effort targeting paradigm-shifting international assets and our China-centric execution platform enable our partners to access China and other major Asian markets to unlock value,” Lianbio’s CEO Bing Li told BioWorld.

Launched on Aug. 11, Lianbio was founded, seeded, and incubated by a hedge fund called Perceptive Advisors with the aim of bringing in first-in-class drugs. Perceptive Advisors will help the startup pick assets that thought to have a good chance of becoming clinically successful.

Currently in the startup’s pipeline are one cardiorenal asset, mavacamten, from Myokardia and two oncology candidates, SHP2 inhibitor BBP-398 and FGFR inhibitor infigratinib, from Bridgebio. Lianbio also has preferential future access to Bridgebio’s portfolio of over 20 product candidates.

Mavacamten is a first-in-class small-molecule therapeutic that reversibly binds to myosin to directly target the excess contractility and impaired relaxation underlying hypertrophic cardiomyopathy (HCM). Lianbio will pay Myokardia $40 million plus regulatory and sales milestone payments of up to $147.5 million to obtain the rights to develop and commercialize it in China and other Asian territories.

The molecule is being developed for treating HCM and those with heart failure with preserved ejection fraction. It is now in phase III for obstructive HCM and Myokardia plans to seek NDA in the U.S. in the first quarter of 2021. In China, Lianbio’s cardiorenal-focused subsidiary, Lian Cardiovascular, will work to move mavacamten to registration for obstructive HCM and plans to develop it for more indications, while funding all development and commercial expenses in China and Asia.

“HCM is estimated to affect more than 1 million people in China alone,” said Li. “Mavacamten’s mechanism is directed to the hypercontractility that drives HCM.”

Lianbio also unveiled its deal with Bridgebio on the same day. Up-front and milestone payments amounted to $26.5 million, plus up to $505 million in future milestone payments and tiered royalties from single- to double-digits on net sales of both infigratinib and BBP-398. The startup will have commercial rights to both drugs in China and selected Asian markets and will take part in their clinical development.

Developed by Bridgebio’s subsidiary Qed Therapeutics Inc., infigratinib is now in phase III trials for cholangiocarcinoma and urothelial carcinoma among other FGFR-driven diseases. Lianbio is participating in the ongoing phase III study in first-line cholangiocarcinoma in China as part of the global study, while also planning to initiate a phase IIa study in gastric cancer and other FGFR-driven tumors.

BBP-398 is being developed by another Bridgebio’s subsidiary, Navire Pharma Inc. The phase I-ready candidate is designed to treat tumors driven by RAS and receptor tyrosine kinase mutations. Lianbio will take part in developing BBP-398 in combination with various agents in solid tumors such as non-small cell lung cancer, colorectal cancer, and pancreatic cancer, in China and other major Asian markets.

Bridgebio said this partnership with Lianbio marks the first major expansion of its pipeline into Asian markets.

Speaking to BioWorld, Li said the startup will take advantage of several important tailwinds in China, citing the regulatory reforms that support the development of China’s innovative pharma market and enable China to be part of global development efforts, market access, and reimbursement evolution, and the reality that Chinese consumers are increasingly ready to embrace a new generation of therapies.

Lianbio has operations both in China and the U.S. “In Shanghai, we have colleagues who have extensive drug development and regulatory experience. In the U.S., we house our business development and alliance management teams. These teams work seamlessly together to drive our mission forward,” Li added.

Li has been in the biotech industry for many years. Before joining Lianbio, he served at China Biologic Products, Fosun Pharma, Warburg Pincus, GSK China Enterprises and Eli Lilly. He has developed expertise in health care investment, business development strategy and biotech practice.

His experience led him to shaping Lianbio’s business strategy into one that focuses on late-stage assets and programs ripe for development in China and major Asian markets through strategic partnership, licensing and development agreements.

Leading Linabio alongside with Li is Debra Yu, who has experience in healthcare investment and business development strategy. She was with Pfizer Inc., Wuxi Apptec and China Renaissance Securities before joining Lianbio as president and chief business officer.

Both Li and Yu’s expertise explains Lianbio management’s strong background in investment and strategy planning rather than R&D, as they are familiar with the cross-border pharmaceutical landscape. Li believes this is how Lianbio will stand out from other biotech startups.

“We can make strategic partnerships with top-tier life science companies that provide key anchoring relationships for key therapies fit for development and commercialization in our territories, and we have the ability to attract talent well-versed in cross-border global and local development strategies and deal making,” Li explained.

No Comments