On February 29, 2024 4SC AG (4SC, FSE Prime Standard: VSC), a biotech company improving the lives of patients suffering with advanced-stage cutaneous T-cell lymphoma (CTCL), reported that it has filed its Marketing Authorisation Application (MAA) for resminostat (Kinselby) with the European Medicines Agency (EMA) and that its MAA has been accepted by the EMA as sufficient for examination (Press release, 4SC, MAR 1, 2024, https://www.pressetext.com/news/20240301006 [SID1234640681]).

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In September 2023, the Company announced data from its RESMAIN study on resminostat (Kinselby) that showed:

A statistically significant improvement in progression free survival (median PFS: 8.3 vs. 4.2 months; p=0.015; HR: 0.623)
A median time to next treatment versus placebo showed a significant improvement of 8.8 months compared to 4.2 months
A clinically meaningful improvement in median "total" PFS of 24.3 months, compared to 14.9 months for those in the placebo group

Side effects of resminostat were mainly mild to moderate, manageable and reversible.
Jason Loveridge, Ph.D., CEO of 4SC, commented: "The team has worked hard to successfully file the Marketing Authorisation Application for resminostat in CTCL ahead of schedule. This represents a significant step forward for 4SC and a great achievement for our team as it further de-risks our resminostat program and will assist our ongoing efforts to bring this important treatment to patients suffering with this disease, commercialise the asset and create value for shareholders."

On February 29, 2024 Taiho Pharmaceutical Co., Ltd. (hereinafter "Taiho") and Haihe Biopharma Co., Ltd. (hereinafter "Haihe") reported that two companies have entered into an exclusive license agreement regarding the development, manufacturing and commercialization of gumarontinib (development code : SCC244), agent for non-small cell lung cancer, which application for marketing authorization has been submitted and is currently being reviewed in Japan by Haihe Biopharma K. K., fully owned affiliate of Haihe (Press release, Taiho, MAR 1, 2024, View Source [SID1234640679]).

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Under the license agreement, Taiho will obtain exclusive rights in Japan, Asia (excluding China) and Oceania to develop, manufacture and commercialize, gumarontinib, Haihe will receive an upfront payment, development and sales milestones, and royalty based on sales revenue from Taiho.

Gumarontinib is an oral, small molecule MET inhibitor discovered by Haihe. In September 2023, Haihe Biopharma K. K., submitted new drug application of gumarontinib in Japan for the treatment of unresectable, advanced or recurrent non-small cell lung cancer (NSCLC) with MET exon 14 (METex14) skipping mutations as possible indications. Gumarontinib has been approved in China in March 2023 by NMPA (National Medical Products Administration) for the treatment of non-small cell lung cancer (NSCLC) with METex14.

"We are pleased to announce that we will be entering into a partnership withHaihe on gumarontinib, a new treatment option for the patients with non-small cell lung cancer. We will be preparing for the successful launch of gumarontinib with Haihe to contribute to the patients and healthcare professionals." stated Masayuki Kobayashi, President and Representative Director of Taiho.

"We are pleased to announce that we are entering into partnership with Taiho, one of the leading companies of oncology in Japan. We hope our collaboration shall be able to provide a promising treatment option for the patients with nonsmall cell lung cancer." stated Ruiping Dong, M.D., Ph.D., Chief Executive Officer of Haihe.

Taiho and Haihe through its alliance, will make every effort to deliver gumarontinib to patients and healthcare professionals as soon as possible.

About NSCLC with METex14 Skipping Mutations

Primary lung cancer is the malignant tumor with one of the highest morbidity and mortality. Globally, the number of new patients with lung cancer is estimated to be 2.2 million/year and the number of deaths to be 1.79 million/year (2020)1). In Japan, the number of new patients with lung cancer is more than 120,000/year (2019) and the number of deaths is over 70,000. /year (2020) 2). The proportion of non-small cell lung cancer among lung cancer patients in Japan is 88%, and the frequency of mesenchymal epithelial transforming factor (MET) gene exon 14 skipping mutation is about 3% 3). Thus, in Japan, the number of patients eligible for treatment with this drug is estimated to be around 3,000/year.