At the end of the year, the overseas boom of the biopharmaceutical industry continues.
Recently, Sanofi and Jixing Pharmaceutical jointly announced the signing of a formal agreement, which stipulates that Sanofi will acquire Jixing's exclusive rights to develop and commercialize aficamten in Greater China. The transaction is expected to be completed within 2024, and the transaction amount is not publicly disclosed.
At present, the US Food and Drug Administration (FDA) has accepted a new drug application (NDA) for aficamten for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM). The China National Medical Products Administration has also officially accepted the new drug application for the treatment of OHCM with ficamten tablets and included it in the priority review category.
Successfully held hands with Sanofi
It is understood that aficamten is a new generation of selective small molecule cardiac myosin inhibitor under development, discovered and globally developed by Cytokinetics. In July 2020, Jixing Pharmaceutical obtained exclusive licensing rights to develop and commercialize aficamten in Greater China.
Mou Yanping, Executive Director and CEO of Jixing Board of Directors, introduced that in just four years, the company has closely cooperated with Cytokinetics to conduct phase I to III clinical trials of aficamten as a potential therapy for the treatment of oHCM in China, and ultimately obtained NMPA's acceptance of its application for listing in China.
Aficamten is still being evaluated in the following studies: MAPLE-HCM， A phase III clinical study aimed at evaluating the safety and efficacy of aficamten monotherapy and metoprolol monotherapy in patients with obstructive HCM; ACACIA-HCM， Phase III clinical study on the efficacy and safety of aficamten in patients with non obstructive hypertrophic cardiomyopathy (nHCM); CEDAR-HCM， Clinical study on children with obstructive HCM; And FOREST-HCM, an open label extended clinical study on aficamten for HCM patients.
Regarding the collaboration with Sanofi, Mou Yanping stated that it reflects Jixing's corporate mission to develop and provide innovative drugs for patients with cardiovascular metabolic diseases who have a huge and urgent unmet treatment demand. Sanofi is a leading multinational pharmaceutical company with outstanding innovative drug development practices, commercialization experience, and strong performance in the field of cardiovascular disease treatment in China. We believe that with the continued promotion of Sanofi, the vast number of HCM patients in China will soon benefit from aficamten treatment.
[align center] Enters GLP-1
Jixing Pharmaceutical was founded in 2019 by RTW Investments (LP), headquartered in the United States and China, focusing on developing innovative cardiovascular metabolic therapies. In January of this year, Bayer and RTW Investment jointly led the D-round financing of Jixing Pharmaceutical, with amounts of $35 million (approximately 255 million yuan) and $127 million (approximately 927 million yuan), respectively. After the investment, Bayer will obtain priority negotiation rights for the commercialization rights of Jixing's product lines in the cardiovascular and ophthalmic fields.
At present, Jixing Pharmaceutical's entire product pipeline includes 2 clinically under development products with global equity and 3 products with Chinese equity. The global equity research products are JX09 for hypertension and JX10 for acute ischemic stroke (AIS); Chinese equity research products include aficamten, etrapamil, and eye drops LNZ100 for treating presbyopia.
Since December, Jixing Pharmaceutical has been taking frequent actions. In addition to the above cooperation with Sanofi, the company has also reached a strategic cooperation agreement with Yuanda Pharmaceutical on the ophthalmic product Varnikolan Tartrate Nasal Spray (Starrun) and related supporting assets. It is the first and only nasal spray approved for the treatment of dry eye symptoms and signs in China.
After the relevant conditions are met, Yuanda Pharmaceutical will, on the condition of a certain amount of down payment and a certain amount of recent milestone and future sales milestone payments, obtain the exclusive development and commercialization rights and interests of Varnikolan Tartrate nasal spray and related supporting assets in Greater China (Mainland China, Hong Kong Special Administrative Region, Macao Special Administrative Region and Taiwan, China).
In addition, Jixing Pharmaceutical has recently set its sights on the GLP-1 track. On December 23rd, Jixing Pharmaceutical announced the introduction of CX11 (also known as VCT220), an oral small molecule glucagon like peptide-1 receptor agonist (GLP-1 RA), from Wentai Pharmaceutical for global (excluding Greater China) development and commercialization rights.
CX11 is an oral small molecule GLP-1 RA under research for the treatment of cardiovascular and metabolic diseases, including obesity and type 2 diabetes. CX11 can be taken orally once a day, which has better medication convenience and ease of operation compared to injections, and also has production cost advantages.
According to Jixing Pharmaceutical, a phase II clinical study conducted in China showed that CX11 exhibited more competitive weight loss effects than current similar drugs, and demonstrated good safety and tolerability. A registered Phase III clinical study targeting obese and overweight patients in China has been launched in November 2024, and Jixing plans to launch a global (excluding Greater China) Phase II clinical study targeting obese and overweight patients in 2025.
In the same track, the world's first and only GLP-1RA oral agent is Novo Nordisk's Novo Xin, which was approved in China in January this year for the treatment of adult type 2 diabetes.
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