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3/8

2023

Haihe Biopharma Announces Gumarontinib Receives Approval from the NMPA of China for the Treatment of Locally Advanced or Metastatic NSCLC with MET Exon 14 Skipping Mutation

Shanghai, Mar 8, 2023, Haihe Biopharma Co., Ltd. (hereby referred to as "Haihe Biopharma" or the “Company”) today announced that the National Medical Products Administration (NMPA) of China has given conditional approval to Gumarontinib (INN), an oral highly selective mesenchymal-epithelial transition (MET) inhibitor and a Category 1 innovative new chemical drug that the Company has co-developed with Shanghai Institute of Material Medica, Chinese Academy of Sciences, for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with MET exon 14 skipping mutation. Full approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial. Gumarontinib was granted by NMPA as Breakthrough Therapy program and reviewed under Priority Review procedure. The approval of Gumarontinib is an important milestone for Haihe Biopharma as it represents a significant breakthrough in our mission to address unmet medical needs.

The approval was supported by results from a Phase II clinical trial “GLORY” (NCT04270591) in adult patients with locally advanced or metastatic NSCLC harboring MET exon 14 skipping mutation. The GLORY trial demonstrated tolerable and manageable safety and exciting efficacy results in naïve and treated patients with locally advanced or metastatic NSCLC harboring MET exon 14 skipping mutation.

A total of 79 patients with MET exon 14 skipping mutation confirmed by the central laboratory were enrolled in the GLORY study. The confirmed overall objective response rate (ORR) per Blinded Independent Review Committee (BIRC) was 65.8%, including 70.5% ORR for treatment-naïve patients and 60.0% ORR for previously - treated patients at 12-months follow-up. The median progression-free survival (PFS) was 8.5 months, 11.7 months and 7.6 months for overall population, treatment-naïve and previously treated patients respectively. Additionally, the median overall survival (OS) was 17.3 months and 16.2 months for overall population and previously - treated patients respectively, and it has not reached in treatment-naïve patients to the date of this report.

In terms of safety, it could be well tolerated. The most common adverse reaction observed in the trial was edema. No potential phototoxicity or allergic reactions were observed in the trial, the safety risk for combination use is low due to few drug-drug interaction potential.

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

“Lung cancer is the leading cause of cancer-related death globally. We are excited that Gumarontinib is approved by NMPA, our first approved oncology product in China. We would like to thank all the patients, physicians and operation staff in this trial for their great efforts. NMPA’s approval reinforces the company's bold vision to deliver novel treatments for patients with cancer all over the world.”

Professor Shun Lu, from the Oncology Department of Shanghai Chest Hospital, commented,

"Congratulations to the approval for Gumarontinib! Gumarontinib has a rapid onset of anti-tumor activity and it has compelling clinical efficacy and good tolerance in both the treatment-naïve and previously treated NSCLC patients with MET exon 14 skipping mutation. On top of that, patients with brain metastases also have clear benefits. I believe that the approval of Gumarontinib may help more patients with advanced NSCLC patients with MET alterations."

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. as of today, 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 granted Orphan Drug Designation (ODD) by the Food and Drug Administration (FDA) in the Unites States for the treatment of non-small cell lung cancer (NSCLC) with MET genomic aberration.

About MET Exon 14 Skipping Mutation and NSCLC

Lung cancer is the malignant tumor with the highest morbidity and mortality in China. 85% of lung cancer is NSCLC¹. MET exon 14 skipping mutation occurs in 3% of NSCLC patients² and 1.3% of NSCLC in China³. MET exon 14 skipping mutation is a primary oncogenic driver gene and does not typically overlap with other genetic variants such as EGFR, KRAS, and ALK ⁴. In metastatic NSCLC patients with MET exon 14 skipping mutation, data suggests PFS was 2.9 months and OS was 7.9-8.3 months for chemotherapy⁵. The response rate was 16 to 17% and PFS was 1.9 to 3.4 months for immune checkpoint inihibitors^6,7.

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, focusing on the research, development, manufacturing and commercialization of innovative anti-tumor therapies. The Company aims to discover and deliver life-saving therapies to cancer patients world widely. As an R&D focused company led by an academician of the Chinese Academy of Engineering, Haihe Biopharma is committed to in-house innovation. The Company has a full R&D and management team with global perspectives and is proactively mapping out its global drug development strategy. The Company currently has thirteen drug candidates. As of today, Haihe Biopharma has received total 33 clinical trial approvals and has been conducting clinical trials in four major countries.

Reference
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[4]. Vuong, H.G., et al., Clinicopathological implications of MET exon 14 mutations in non-small cell lung cancer - A systematic review and meta-analysis. Lung Cancer, 2018. 123: p. 76-82.
[5]. Ciuleanu T, Brodowicz T, Zielinski C, et al (2009) Maintenance pemetrexed plus best supportive care versus placebo plus best supportive care for non-small-cell lung cancer: a randomised, double-blind, phase 3 study. Lancet, 374:1432-40.
[6]. Ettinger DS, Akerley W, Bepler G, et al (2010), Non-small cell lung cancer. J Natl Compr Canc Netw, 8:740–801.
[7]. Paz-Ares L, Luft A, Vicente D et al (2018), Pembrolizumab plus chemotherapy for squamous non-small cell lung cancer. N Engl J Med, 379:2040-51