Hansoh Pharma Secures Nearly RMB 1.5 Billion Deal with GSK for B7-H4 ADC HS-20089

　　【Pharmaceutical Network Industry Dynamics】The international development and global layout of innovative drug companies have become hot topics of discussion among market participants. Nowadays, an increasing number of innovative drugs are beginning to enter international markets. According to statistics, in the first half of this year, there were 27 License-out (outward licensing) deals in China, equaling the total number of transactions for the entire previous year. In terms of value, the disclosed total amount exceeded 12.4 billion US dollars, more than three times that of the same period last year. Since entering October, several pharmaceutical companies have successfully reached overseas licensing agreements for their innovative drugs.
 

As announced by Hansoh Pharma on the Hong Kong Stock Exchange on October 20, the group's wholly-owned subsidiary, Shanghai Hansoh Biomedical Technology Co., Ltd., entered into a licensing agreement with GlaxoSmithKline Intellectual Property (No.4) Limited. Under this agreement, the licensee will be granted an exclusive global license (excluding mainland China, Hong Kong, Macao, and Taiwan regions) to develop, manufacture, and commercialize HS-20089. The licensee is a wholly-owned subsidiary of GlaxoSmithKline (GSK), a global biopharmaceutical company headquartered in London, UK.
 

Data shows that this product is a novel B7-H4-targeted antibody-drug conjugate (ADC) with a topoisomerase inhibitor (TOPOi) as its payload. According to the licensing agreement and its terms and conditions, the licensor will receive an upfront payment of $85 million and is eligible to receive milestone payments of up to $1.485 billion upon the achievement of related events for this product. After the commercialization of the product, the licensee will also pay tiered royalties on global net sales outside of mainland China, Hong Kong, Macau, and Taiwan.
 

According to the review, in October, Hengrui Medicine successfully brought multiple innovative drugs overseas. On October 8, Hengrui Medicine announced that it had granted an exclusive, royalty-bearing license to Indian listed company Dr. Reddy's Laboratories for the development and commercialization of its self-developed human epidermal growth factor 1/2/4 (HER1/HER2/HER4) targeted drug, maleate pyrotinib tablets (hereinafter referred to as "pyrotinib"), within India. Hengrui received a $3 million upfront payment and is entitled to receive up to $152.5 million in sales milestone payments. It is reported that this year, Hengrui Medicine has achieved License-out (overseas licensing) for three innovative drugs.
 

On October 17, Hengrui Medicine also announced that the company had granted Elevar Therapeutics ("Elevar"), a U.S.-based company, the exclusive rights to develop and commercialize its self-developed Class 1 new drug, PD-1 inhibitor Camrelizumab, in combination with Rivoceranib (marketed in China as Apatinib) for the treatment of hepatocellular carcinoma ("combination therapy") outside Greater China and South Korea.
 

The announcement disclosed that, according to the terms of the agreement, based on the first marketing approval of Camrelizumab in the United States, Japan, and certain agreed European countries as well as the actual annual net sales, Elevar will pay Hengrui cumulative sales milestone payments of 600 million US dollars after reaching a certain cumulative net sales threshold, with additional payments made after exceeding a certain cumulative net sales amount, plus a sales royalty of 20.5% of the actual annual net sales.
 

Moreover, on October 12, Yilian Biotech announced that it has granted BioNTech exclusive rights to develop, manufacture, and commercialize one of its ADC (antibody-drug conjugate) products in overseas markets. The two parties will collaborate to develop a next-generation ADC candidate targeting human epidermal growth factor receptor 3 (HER3). BioNTech will pay Yilian Biotech an upfront payment of $70 million, along with additional development, regulatory, and commercial milestone payments, with a potential total amount exceeding $1 billion.
 

On the same day, EpimAb Biotherapeutics announced a bispecific antibody licensing agreement with Almirall. According to the agreement, Almirall will obtain a license to generate, develop, and commercialize bispecific antibodies using EpimAb's proprietary Fabs-In-Tandem Immunoglobulin (FIT-Ig®) platform technology. Almirall will hold global exclusive rights to these bispecific antibodies. EpimAb Biotherapeutics is entitled to receive up to a total of $210 million in milestone payments based on the market launch and commercial success of multiple products, plus royalties based on net sales revenue for any commercialized products. However, further details regarding the financial terms have not been disclosed.
 

Experts in the industry indicate that the trend of Chinese innovative drugs going global is gradually becoming normalized. According to data statistics, as of June 30 this year, more than 20 innovative drugs in China have achieved License-out (external licensing) within the year, involving companies such as Hengrui Medicine, Harbour BioMed, and CSPC Pharmaceutical Group. However, the path for Chinese innovative drugs to go global has not been smooth sailing—some have succeeded, while others have faced "returns." Since the second half of this year, the overseas development and commercial rights of innovative drugs from several pharmaceutical companies, including BeiGene, JACOBIO, CStone Pharmaceuticals, and I-Mab, have been successively returned by foreign pharmaceutical enterprises.
 

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