TYK Medicines, Inc. (HKEX: 2410), a Huzhou, China-based oncology drug developer, has struck a license and collaboration agreement with Qilu Pharmaceutical (HKEX: 3696) that hands the latter exclusive Mainland China rights to TY-9591 (Kardorisso), an irreversible EGFR tyrosine kinase inhibitor awaiting approval from China's drug regulator. The license deal is paired with a supply and commercialization agreement and a separate equity subscription, together worth up to RMB 2.76 billion (approximately USD 408 million) if all regulatory and indication-expansion milestones are met.
TY-9591 is a small-molecule EGFR inhibitor originated by TYK and now under priority review at China's Center for Drug Evaluation, with a new drug application accepted in early 2026. TYK describes the compound as differentiated by favorable pharmacokinetics that reduce toxic metabolite formation, with particularly strong activity reported in EGFR-mutant non-small cell lung cancer patients with brain metastases and those carrying the L858R mutation. A combination study pairing TY-9591 with chemotherapy is being prepared for a registrational trial.
The license grants Qilu an exclusive, sublicensable, and royalty-bearing right to develop, manufacture, and commercialize TY-9591 within Mainland China. TYK will handle technology transfer for TY-9591 API development, while Qilu assumes responsibility for API manufacturing and for sales, promotion, and regulatory filings in the designated territory. Under the license agreement alone, TYK is entitled to an upfront cash payment of RMB 300 million (approximately USD 44.3 million) plus up to RMB 2.06 billion (approximately USD 304.5 million) in milestones tied to regulatory approvals and indication expansion. Royalty rates were not disclosed.
Layered on top is a three-year supplies and commercialization agreement under which TYK will sell finished product to Qilu as a tier-1 distributor, while paying Qilu marketing fees calculated against net sales.