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2024
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.
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.
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.
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.
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.
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
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Brand name |
HAIYITAN® tablets 50mg |
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Generic name |
Gumarontinib hydrate |
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Indications |
Unresectable, advanced or recurrent non-small cell lung cancer with MET exon 14 skipping mutations |
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Dosage and administration |
Normally, for adults, oral administration in fasting condition of 300mg of gumarontinib once daily. Dosage should be reduced based on the patient’s condition. |
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Date of manufacturing and marketing approval |
June 24, 2024 |
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Date listed in NHI reimbursement price listing |
August 15, 2024 |
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Date of initial marketing in Japan |
October 11, 2024 |
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NHI reimbursement price |
JPY 4,382.30 / tablet |
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Packaging |
PTP Packaging: 24 tablets (8 tablets x 3) |
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Manufacturer and distributor |
Haihe Biopharma K. K. |
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Distributor |
Taiho Pharmaceutical Co., Ltd. |
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. 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. For more information about Taiho Pharmaceutical, please visit https://www.taiho.co.jp/en/
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. Haihe Biopharma is committed in-house innovation with global perspective management and R&D team. Currently Haihe Biopharma has one approved product Gumarontinib (INN) in China and Japan and several drug candidates. Haihe Biopharma K. K. is a fully owned affiliate of Haihe Biopharma Co., Ltd. and has been introducing a rich pipeline of novel anticancer drugs to contribute the better treatment of patients in Japan.
