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11/18

2023

Haihe Biopharma Announces CDE Granted Breakthrough Therapy Designation to Gumarontinib for Non-small Cell Lung Cancer with MET Overexpression

Shanghai, China, November 18, 2023 - Haihe Biopharma (Haihe), a company focused on the discovery, development, and commercialization of innovative oncology drugs, announced that the proprietary innovative drug, Gumarontinib (R&D code: SCC244), was granted Breakthrough Therapy Designation by CDE again for the treatment of driver genes-negative, locally advanced or metastatic non-small cell lung cancer (NSCLC) with MET overexpression (IHC3+) who have progressed after prior immunotherapy and platinum-based chemotherapy.

Breakthrough Therapy Drugs include innovative medicines for the prevention and treatment of severe, life-threatening diseases with no effective prevention or treatment, have significant clinical advantages over existing treatments. The drugs with Breakthrough Therapy Designation (BTD) may be applied for conditional approval and priority review of its NDA. The BTD could expedite the clinical development of Gumarontinib and address unmet needs in new indication patients in a fast way.

Dr. Ruiping Dong, Chief Executive Officer of Haihe Biopharma, stated,

"The Breakthrough Therapy designation by CDE again is another important milestone in the on-going development of Gumarontinib. We look forward to more indications approval for Gumarontinib, accelerating our products into the international market and eventually benefiting more patients."

Prof. Shun Lu, SCC244-G303 Global Leading PI, commented,

"Currently, the second-line treatments for advanced driver gene-negative NSCLC progressedafter prior immunotherapy and platinum-based chemotherapy are limited. Docetaxel is the main standard of care for these patients; however efficacy is poor. No drug has been approved for advanced NSCLC with MET overexpression. The previous clinical studies of Gumarontinib demonstrated promised clinical efficacy in advanced driver gene-negative NSCLC with MET overexpression, which indicated that Gumarontinib may be a potential solution for NSCLC patients with MET overexpression."

About Gumarontinib

Gumarontinib (code: SCC244) is an oral, potent and highly selective small molecule MET inhibitor. Gumarontinib has shown excellent pharmacokinetic characteristics, highly effective and durable efficacy and favorable safety profile in NSCLC patients with MET alterations. Compared with its competitors, Gumarontinib has long half-life to achieve sustained target inhibition, low DDI potential to enable less co-medication restrictions, convenient QD regimen. Gumarontinib has been approved by the NMPA in China with Breakthrough Therapy Designation for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with MET exon 14 skipping mutation on March 7, 2023.

About Haihe Biopharma Co., Ltd

Haihe Biopharma Co., Ltd is a global, values-based, R&D driven biopharmaceutical leader headquartered in China with operation centers in the US and Japan, and mainly focuses on innovative anti-tumor therapies. The company has the fully capability of drug discovery, development, manufacture and commercialization and delivers life-saving therapies to cancer patients in China, even the world widely. As an R&D focused company led by an academician of the Chinese Academy of Engineering, Haihe Biopharma is committed in-house innovator with global perspective management and R&D team. Currently Haihe Biopharma has one approved product (Gumarontinib, Haiyitan^®) in China and multiple drug candidates in the pipeline.