Haihe Biopharma Co., Ltd. (hereinafter “Haihe”) and Taiho Pharmaceutical Co., Ltd. (hereinafter “Taiho”) announced today that the MET inhibitor, HAIYITAN® tablets 50mg (generic name: gumarontinib hydrate), is schedule for launch on October 11, 2024, in Japan.

海河生物制药股份有限公司（以下简称“海河”）和泰和制药股份有限公司（以下简称“泰和”）今天宣布，MET抑制剂海依坦®片剂50mg（通用名：水合古马龙替尼）计划于2024年10月11日在日本上市。

In June 2024, Haihe Biopharma K. K., a fully owned affiliate of Haihe, obtained approval to manufacture and market HAIYITAN in Japan for the treatment of unresectable, advanced or recurrent non-small cell lung cancer with MET exon 14 skipping mutations.

2024年6月，海河生物制药有限公司（Haihe Biopharma K.K.）获得批准，在日本生产和销售海依坦，用于治疗不可切除的，晚期或复发的MET外显子14跳跃突变的非小细胞肺癌。

HAIYITAN is an oral, small-molecule, receptor-type tyrosine kinase MET inhibitor developed by Haihe. HAIYITAN is expected to inhibit tumor growth by blocking MET phosphorylation and downstream signaling.1 In China, HAIYITAN has been approved by the National Medical Products Administration (NMPA) for manufacturing and marketing in March 2023. .

海依坦是海河开发的口服小分子受体型酪氨酸激酶MET抑制剂。海依坦有望通过阻断MET磷酸化和下游信号传导来抑制肿瘤生长。在中国，海依坦已于2023年3月获得国家医药产品管理局（NMPA）的生产和销售批准。。。

Taiho and Haihe, together with Haihe Biopharma K. K., will contribute to patients with non-small cell lung cancer and healthcare professionals by providing HAIYITAN as a new treatment option for non-small cell lung cancer.

泰和和海河以及海河生物制药有限公司将为非小细胞肺癌患者和医疗保健专业人员提供海依坦作为非小细胞肺癌的新治疗选择。

About Non-Small Cell Lung Cancer with MET exon 14 Skipping Mutations

关于MET外显子14跳跃突变的非小细胞肺癌

Primary lung cancer is the second most common malignancy in the world and has the highest mortality rate.2 In Japan, the number of new patients with lung cancer is reported to be more than 120,000/year (2019), and the number of deaths is over 70,000/year (2020).3 The percentage of non-small cell lung cancer among patients with lung cancer in Japan is 88%, and the frequency of MET exon 14 skipping mutations is about 3%.4 Thus, in Japan, the number of patients with MET exon 14 skipping gene mutations positive, unresectable, advanced or recurrent non-small cell lung cancer who are eligible for treatment with HAIYITAN is estimated to be around 1,200/year..

原发性肺癌是世界上第二大常见恶性肿瘤，死亡率最高。2在日本，据报道新发肺癌患者人数超过120000/年（2019年），死亡人数超过70000/年（2020年）。3日本肺癌患者中非小细胞肺癌的比例为88%，MET外显子14跳跃突变的频率约为3%。4因此，在日本，MET外显子14跳跃基因突变阳性，不可切除，晚期或复发的非小细胞肺癌患者人数估计为1200/年左右。。

About MET Tyrosine Kinase

关于MET酪氨酸激酶

MET gene encodes a receptor-type tyrosine kinase. Binding hepatocyte growth factor (HGF), a MET ligand, induces receptor dimerization and autophosphorylation of tyrosine residues in the kinase domain of MET, forming binding sites for various signaling factors. Subsequently, intracellular signaling cascades such as the RAS pathway are activated to stimulate tumor cell growth, migration, invasion, and angiogenesis in cancer.5.

。结合肝细胞生长因子（HGF）是一种MET配体，可诱导MET激酶结构域中酪氨酸残基的受体二聚化和自磷酸化，形成各种信号因子的结合位点。随后，细胞内信号级联如RAS通路被激活，以刺激肿瘤细胞的生长，迁移，侵袭和血管生成。

Summary of Product Information in Japan

Brand name

品牌名称

HAIYITAN® tablets 50mg

海逸潭® 50毫克片剂

Generic name

通用名称

Gumarontinib hydrate

水合Gumarontinib

Indications

适应症

Unresectable, advanced or recurrent non-small cell lung cancer with MET exon 14 skipping mutations

具有MET外显子14跳跃突变的不可切除，晚期或复发性非小细胞肺癌

Dosage and administration

剂量和给药

Normally, for adults, oral administration in fasting condition of 300mg of gumarontinib once daily. Dosage should be reduced based on the patient’s condition.

正常情况下，对于成年人，空腹口服300mg gumarontinib，每天一次。应根据患者的病情减少剂量。

Date of manufacturing and marketing approval

制造和上市批准日期

June 24, 2024

2024年6月24日

Date listed in NHI reimbursement price listing

NHI报销价格清单中列出的日期

August 15, 2024

2024年8月15日

Date of initial marketing in Japan

首次在日本上市日期

October 11, 2024

2024年10月11日

NHI reimbursement price

NHI报销价格

JPY 4,382.30 / tablet

4.382.30日元/片

Packaging

包装

PTP Packaging: 24 tablets (8 tablets x 3)

PTP包装：24片（8片x 3片）

Manufacturer and distributor

制造商和分销商

Haihe Biopharma K. K.

海河生物制药有限公司。

Distributor

Taiho Pharmaceutical Co., Ltd.

泰和药业股份有限公司。

About Taiho Pharmaceutical Co., Ltd. (Japan)

关于日本太和制药有限公司

Taiho Pharmaceutical, a subsidiary of Otsuka Holdings Co., Ltd. (https://www.otsuka.com/en/), is an R&D-driven specialty pharma focusing on the fields of oncology and immune-related diseases. Its corporate philosophy takes the form of a pledge: “We strive to improve human health and contribute to a society enriched by smiles.” In the field of oncology, in particular, Taiho Pharmaceutical is known as a leading company in Japan for developing innovative medicines for the treatment of cancer, a reputation that is rapidly expanding through their extensive global R&D efforts.

大冢控股有限公司的子公司太和制药(https://www.otsuka.com/en/)是一家研发驱动的专业制药公司，专注于肿瘤学和免疫相关疾病领域。它的企业理念以承诺的形式：“我们努力改善人类健康，为微笑丰富的社会做出贡献。”特别是在肿瘤学领域，太和制药被称为日本领先的开发创新药物治疗癌症的公司，通过其广泛的全球研发努力，这一声誉正在迅速扩大。

In areas other than oncology, as well, the company creates and markets quality products that effectively treat medical conditions and can help improve people’s quality of life. Always putting customers first, Taiho Pharmaceutical also aims to offer consumer healthcare products that support people’s efforts to lead fulfilling and rewarding lives.

在肿瘤学以外的领域，该公司还创造并销售优质产品，这些产品可以有效治疗医疗状况，并有助于提高人们的生活质量。泰和制药始终把客户放在第一位，还致力于提供消费者保健产品，支持人们努力过上充实而有意义的生活。

For more information about Taiho Pharmaceutical, please visit https://www.taiho.co.jp/en/.

有关泰和制药的更多信息，请访问https://www.taiho.co.jp/en/.

About Haihe Biopharma Co., Ltd.

关于海河生物制药有限公司。

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.

海河生物制药有限公司是一家全球性、基于价值观、研发驱动的生物制药领导者，总部位于中国，运营中心位于美国和日本，主要专注于创新的抗肿瘤疗法。该公司具有药物发现、开发、制造和商业化的综合能力，并为中国和世界各地的癌症患者提供挽救生命的疗法。

As an R&D focused company with many experts skilled in developing new drugs, Haihe Biopharma is committed to in-house innovation with global perspective management and R&D team. For more information about Haihe Biopharma, please visit https://www.haihepharma.com/en .

海河生物制药是一家专注于研发的公司，拥有众多熟练开发新药的专家，致力于通过全球视角的管理和研发团队进行内部创新。有关海河生物制药的更多信息，请访问https://www.haihepharma.com/en。。

Haihe Biopharma K. K. has been established as fully owned affiliate of Haihe Biopharma Co., Ltd. since 2021. The Company will introduce rich pipeline of novel anticancer drugs from Haihe Biopharma Co., Ltd. in Japan.

自2021年起，海河生物制药有限公司成立为海河生物制药有限公司的全资子公司。该公司将从日本海河生物制药有限公司引进丰富的新型抗癌药物管道。

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Ai J，Chen Y，Peng X，et al。SCC244（Glumetinib）的临床前评估，SCC244是一种新型，有效且高度选择性的c-Met抑制剂，用于Met依赖性癌症模型。摩尔癌症治疗。2018年；17（4）：751-762

Sung, H, Ferlay J, Siegel RL, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021;71(3): p. 209–249.

Sung，H，Ferlay J，Siegel RL，et al。《2020年全球癌症统计：GLOBOCAN对185个国家36种癌症的全球发病率和死亡率的估计》。CA癌症J临床。2021年；71（3）：第209-249页。

Cancer information service “Cancer Statistics” of National Cancer Institute as of 12th September 2024 https://ganjoho.jp/reg_stat/statistics/stat/cancer/12_lung.html

截至2024年9月12日，国家癌症研究所癌症信息服务“癌症统计”https://ganjoho.jp/reg_stat/statistics/stat/cancer/12_lung.html

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Vuong HG，Ho ATN，Altibi AMA等。MET外显子14突变在非小细胞肺癌中的临床病理学意义-系统评价和荟萃分析。肺癌。2018年；123:76-82。

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Tomoyuki Naito等人。针对MET改变的肺癌治疗。日本肺癌杂志。