Haihe Biopharma Announces New Drug Application in Japan for MET inhibitor - Gumarontinib (SCC244) in Non-Small Cell Lung Cancer with MET exon 14 skipping mutation

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2023

September 8, 2023, Minato-ku, Tokyo---Haihe Biopharma K. K. (referred as “Company”), fully owned affiliate of Shanghai Haihe Biopharma Co., Ltd (China) announced that the New Drug Application (“NDA”) of Gumarontinib (SCC244) for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with MET exon 14 (METex14) skipping mutation, has been filed to Ministry of Health, Labour and Welfare(厚生労働省).

The indication application is based on the data from the SCC244-108 a pivotal Phase II study (GLORY study), a global multi-center, open-label, single-arm clinical trial to evaluate the efficacy and safety of Gumarontinib in locally advanced or metastatic NSCLC patients with METex14 skipping mutations. This indication has been approved by NMPA in China on March 7, 2023. The global leading principal investigator is Prof. Shun Lu at Shanghai Chest Hospital，China.

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

“The file in Japan for Gumarontinib, demonstrates Haihe’s mission for the global development of the innovative drugs to bring more effective and much safer treatment options for cancer patients around the world, and marks a historic step of Haihe Biopharma’s innovative drug into the global market. We deeply appreciated the contribution from the patients and the efforts from the investigators, and the recognition of Gumarontinib. Haihe Biopharma will continue to file more global New Drug Applications to benefit cancer patients in the world.”

Prof. Shun Lu, the global leading principal investigator of the GLORY study, from the Oncology Department of Shanghai Chest Hospital, commented,

“Gumarontinib is an oral, potent and highly selective MET inhibitor. The GLORY study data demonstrated that Gumarontinib has solid efficacy and good safetyin the treatment naive or previously treated NSCLC patients harboring METex14 skipping mutations, even those with brain metastases. We expect Gumarontinib with better efficacy and acceptable safety could address the unmet needs of patients in China and globally.”

About NSCLC and METex14 Skipping Mutations

Primary lung cancer is the malignant tumor with the highest morbidity and mortality in China. NSCLC accounts for approximately 85% of all lung cancers¹. The total incidence of METex14 skipping mutations in NSCLC is about 3%², and the incidence in Chinese NSCLC population is about 1.3%³.
METex14 skipping mutations is a primary oncogenic driver gene, which usually does not coexist with other lung cancer mutations such as EGFR, KRAS and ALK⁴. Most patients were elderly, with a median age of 72.5 years⁵. METex14 skipping mutations predicted poor prognosis, with progression-free survival (PFS) of only 2.9 months, overall survival (OS) of 7.9 - 8.3 months, and objective response rate (ORR) of 8.8% -- 9.1%⁶ in second-line chemotherapy. NSCLC patients with METex14 skipping mutations were insensitive to PD-1 therapy with ORR ranged from 16 to 17%, median PFS ranged from 1.9 to 3.4 months, and there was no increase in response rate among tumor patients with high PD-L1 expression^7,8 In Japan, the number of new lung cancer patients is 120,000/year (2020) and the number of deaths is 70,000 /year ¹. The proportion of non-small cell lung cancer among lung cancer patients in Japan is 88%, and the frequency of METex14 skipping mutation-positive expression is about 3%³. Thus, in Japan, the number of patients that may be eligible for treatment with this drug is estimated to be around 3,000/year.

About Gumarontinib (SCC244)

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 withless co-medication restrictions, convenient QD regimen. Gumarontinib has been approved by the NMPA in China with breakthrough designation for the treatment of non-small cell lung cancer (NSCLC) with MET genomic aberration.

About Haihe Biopharma

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 comprehensive capability of drug discovery, development, manufacturing and commercialization, and delivers life-saving therapies to cancer patients in China and around the world. As an R&D focused company led by an academician of the Chinese Academy of Engineering, Haihe Biopharma is committed in-house innovation with global perspective management and R&D team. Currently Haihe Biopharma has one approved product (Gumarontinib, Haiyitan^®) in China and several drug candidates.

References
[1].   Sung, H., et al., Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA: A Cancer Journal for Clinicians, 2021. 71(3): p. 209-249.
[2].   国立がん研究センターがん情報サービス「がん統計」（全国がん登録）（2023年8月24日）http://ganjoho.jp/reg_stat/statistics/stat/cancer/12_lung.html
[3].   Cao, W., et al., Changing profiles of cancer burden worldwide and in China: a secondary analysis of the global cancer statistics 2020. Chin Med J (Engl), 2021. 134(7): p. 783-791.
[4].   Jemal, A., et al., Cancer Statistics, 2010. CA: A Cancer Journal for Clinicians, 2010. 60(5): p. 277-300.
[5].   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.
[6].   Zheng, D., et al., MET exon 14 skipping defines a unique molecular class of non-small cell lung cancer. Oncotarget, 2016. 7(27): p. 41691-41702.
[7].   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.
[8].   Ettinger DS, Akerley W, Bepler G, et al (2010), Non-small cell lung cancer. J Natl Compr Canc Netw, 8:740–801.
[9].   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.

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