KeChow Pharma, a commercial-stage pharmaceutical company focused on developing and commercializing differentiated small molecule therapeutics for cancer, today announced that the China National Medical Products Administration (NMPA) has approved tunlametinib (HL-085) for the treatment of patients with NRAS mutated advanced melanoma who were previously treated with PD-1/PD-L1. This is the first approved targeted therapy for this patient population and the first product originated from KeChow's in-house research and development activities since the company's inception.

The new drug application (NDA) of tunlametinib was previously granted priority review by the Center for Drug Evaluation (CDE) of the NMPA. The approval was based on the results of a multicenter, single-arm, phase II, pivotal registrational study which conducted in 100 patients in China (NCT 05217303). Clinical efficacy data of tunlametinib in China, as assessed by independent radiological review committee (IRRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, include an overall response rate (ORR) of 35.8%, median progression free survival (PFS) of 4.2 months, and disease control rate (DCR) of 72.6%. Subgroup analysis showed that in patients who had previously received immunotherapy, the ORR was 40.6%. The most common treatment-related skin event was rash (53%), followed by dermatitis acneiform (24%). The most common grade ≥3 TRAE in this study was blood creatine phosphokinase increased (38.0%), which was mostly asymptomatic and manageable with dose modification ^[1].

"We are excited and proud of this major milestone for KeChow. Tunlametinib, approved in China, is the first internally designed and developed molecule by KeChow team ." said Dr. Hongqi Tian, Founder, Chief Executive Officer and Chairman of KeChow. "The approval of tunlametinib is an important milestone to provide new treatment option for Chinese patients with NRAS-mutated advanced melanoma who previously received PD-1/PD-L1. We would like to express our sincere gratitude to the clinicians and patients who participated in our trials, and we thank the health authorities for their strong support. We are committed to making tunlametinib available in China as soon as possible to serve this patient population."

"We own the worldwide rights to tunlametinib. KeChow has a comprehensive clinical development plan to evaluate tunlametinib as a monotherapy and in combination with other standard of care therapies to treat multiple cancers including melanoma, neurofibromatosis type 1–related plexiform neurofibromas, colorectal cancer, and non-small cell lung cancer in China," said Dr. Hongqi Tian. "We look forward to expanding the product potential of tunlametinib through establishing partnerships on a worldwide basis."

Melanoma is one of the most common cutaneous cancers. There are an estimated 20,000 newly diagnosed melanoma patients in China each year ^[2]. NRAS mutations accounted for 10.4~12.6% of melanoma patients in China ^[3], and 15-25% globally ^[4-7]. NRAS-mutated melanoma is more aggressive and associated with poorer outcomes ^[8-11]. There were no approved targeted therapies for patients with NRAS-mutant melanoma. Tunlametinib is the first small molecule drug approved for this indication.