Haisco Pharmaceutical Group Enters Licensing Agreement with Nuvectis for Two Drug Candidates

Haisco Pharmaceutical Group Co.,Ltd. (SHE: 002653) has announced the signing of an exclusive licensing agreement with U.S.-based Nuvectis Pharma, Inc. Under the terms of the deal, Nuvectis has been granted exclusive global rights, excluding Greater China, to develop, manufacture, and commercialize the HSK42360 project, a BRAF inhibitor.

Additionally, Nuvectis has secured exclusive global rights, excluding Greater China, Southeast Asia, and India, for the development, production, and commercialization of the HSK39297 project, a CFB inhibitor.

As part of the transaction's financial terms, Haisco will receive licensing fees for both projects. This includes an upfront payment of $40 million, near-term milestone payments, and potential additional milestone payments of up to $1.421 billion, along with sales royalties.

About the Drug Candidates

HSK42360 is an internally developed, best-in-class BRAF paradoxical breaker inhibitor. It is designed to inhibit BRAF V600X mutations while simultaneously blocking BRAF dimer formation, potentially overcoming acquired resistance issues observed with first-generation BRAF inhibitors in various cancer treatments.

The molecule exhibits good central nervous system penetration and has shown strong potential therapeutic advantages in both primary brain tumors and brain metastases. It is currently undergoing Phase I clinical studies.

HSK39297 is a highly effective, selective small-molecule inhibitor of complement factor B (FB), also developed internally by Haisco. It works by inhibiting FB activity, thereby blocking the activation of the alternative pathway (AP) and the complement amplification loop, which in turn suppresses the activity of the entire complement pathway. It is intended to treat various diseases mediated by abnormal complement activation.

Currently, a New Drug Application (NDA) for the PNH indication of HSK39297 has been submitted in China. The drug is also in a Phase II clinical trial for lupus nephritis patients and a Phase III clinical study for primary IgA nephropathy.