On December 4th, Merck and Heyu Pharmaceuticals announced an exclusive licensing agreement for a CSF-1R small molecule inhibitor, Pimicotinib (ABSK021). According to the terms of the agreement, Merck will obtain a license to commercialize Pimicotinib for all indications in the Chinese market, and Heyu Pharmaceuticals will reserve the exclusive right to develop Pimicotinib within the authorized area.
Heyu Pharmaceutical will receive a one-time, non refundable down payment of $70 million, and if Merck exercises its global commercialization option, Heyu will also receive additional exercise fees; With the addition of R&D milestone payments and sales milestone payments, the potential total payment amount is expected to exceed 600 million US dollars. In addition, Merck will also pay sales commissions of up to double-digit percentages to Heyu Pharmaceutical.
CSF-1R small molecule inhibitors have been recognized as breakthrough therapeutic drugs and priority drugs for the treatment of inoperable giant cell tumors in China, the United States, Canada, and Europe. Global multicenter phase III clinical trials have been conducted simultaneously in China, the United States, Canada, and Europe.
Since the beginning of this year, China has issued a batch of self developed innovative drugs for external authorization and continuously updated transaction amounts. According to data compiled by the WuXi AppTec team, as of the end of November this year, there have been as many as 36 incidents of Chinese innovative drug external authorization, with a total disclosed transaction amount exceeding 24.4 billion US dollars. The number and amount of transactions have reached a peak since 2020, with a total of 12 transactions exceeding 1 billion US dollars.
From the perspective of transaction types, antibody conjugated drugs (ADC) are the most popular target, with a total of 12 external authorizations involving ADC drugs, of which 7 have a transaction value of over 1 billion US dollars. The highest potential transaction value is an ADC drug authorization targeting HER2, valued at 2 billion US dollars, reached between Baili Sikang and Weicai Company.
Active buyers include multinational pharmaceutical giants such as AstraZeneca, Merck, and BioNTech. Last month, AstraZeneca and Chengyi Biotechnology reached a licensing agreement worth up to $2 billion for the popular small molecule GLP-1 receptor agonist; BioNTech and Yingen Biotech have reached two ADC drug authorizations worth up to $1.67 billion.
From the seller's perspective, Hengrui Pharmaceuticals has achieved four external authorization agreements, including two agreements reached for the first time with multinational pharmaceutical manufacturer Merck regarding the PARP1 inhibitor HRS-1167 and Claudin-18.2 antibody drug conjugate SHR-A1904. Hengrui will receive a down payment of 160 million euros, a technology transfer fee and exercise fee of 90 million euros, as well as milestone payments for research and development and sales, totaling a potential 1.4 billion euros.
Multinational corporations have also seen initial returns on their bets. At the beginning of this year, Hutchison Pharmaceuticals subsidiary Hutchison Whampoa Pharmaceuticals (Shanghai) reached an authorization agreement with its Takeda subsidiary regarding the VEGFR inhibitor furoquinib, with a total transaction amount exceeding 1.1 billion US dollars.
And just last month, fipronil was approved by the US Food and Drug Administration (FDA) for the treatment of advanced colorectal cancer, becoming the first small molecule original anti-tumor drug approved for market in the US in Shanghai.
But not all Chinese innovative drug authorizations can ultimately lead to success. This year, many innovative drugs have also been refunded by multinational giants. In October this year, Kelun Pharmaceuticals announced that its subsidiary Kelun Botai received a notice from Merck that it would terminate the development of two ADC drugs that have not yet entered clinical practice; Due to strategic adjustments, Abbott has completely abandoned its authorized cooperation with Chinese biopharmaceutical company Tianjing Biotechnology and returned its global rights to CD47 immunotherapy antibody drugs.