Home Suzhou-based WuXi Pharma Sells Global Rights to Novel Oral GLP-1 RA CX11, Pivoting into Pivotal Phase III Trial for Obesity

Suzhou-based WuXi Pharma Sells Global Rights to Novel Oral GLP-1 RA CX11, Pivoting into Pivotal Phase III Trial for Obesity

Dec 24, 2024 16:55 CST Updated 16:55
CORXEL

Developer of Oral Small Molecule Cardiac Myosin Inhibitors

On December 23, CORXEL announced that it had licensed the global (excluding Greater China) development and commercialization rights for CX11 (also known as VCT220), an oral small-molecule glucagon-like peptide-1 receptor agonist (GLP-1 RA), from Suzhou Taiwen Pharmaceutical Technology Co., Ltd.

 

According to the announcement, CX11 is an investigational oral small-molecule GLP-1 receptor agonist (GLP-1 RA) being developed for the treatment of cardiovascular and metabolic diseases, including obesity and type 2 diabetes. GLP-1 RAs have been proven effective for weight loss, improving insulin sensitivity, and lowering blood glucose levels.


CX11 is a once-daily oral formulation that offers superior convenience and ease of administration compared to injectable formulations, along with cost advantages in production. Results from a Phase II clinical trial conducted in China demonstrated that CX11 exhibits more competitive weight-loss efficacy than current drugs in the same class, while also showing a favorable safety and tolerability profile. The registrational Phase III clinical trial for patients with obesity and overweight in China was initiated in November 2024. CORXEL plans to launch a global Phase II clinical trial (excluding Greater China) for patients with obesity and overweight in 2025.

 

Currently, CORXEL’s entire product pipeline comprises three late-stage clinical candidates with global rights and two with China-specific rights. The globally licensed assets include CX11 for obesity and diabetes, JX10 for acute ischemic stroke (AIS), and JX09 for hypertension. The China-licensed investigational products include etripamil and LNZ100, an ophthalmic solution for the treatment of presbyopia.


Taiwen Pharma: Develops the Second Domestically Produced GLP-1R Drug to Enter Phase III Trials


Suzhou Taiwen Pharmaceutical Technology Co., Ltd. was established in April 2021 as an innovative pharmaceutical enterprise co-founded by multiple Ph.D. holders from the Chinese Academy of Sciences. Bringing together a team of seasoned experts in small-molecule chemical drug and bioengineered novel drug R&D, the company has built a new drug development platform centered on gastrointestinal hormones. This platform leverages profound insights into the mechanisms of action of metabolic targets and GPCR protein structures, along with AI assistance, to support a pipeline of multiple small-molecule candidates targeting type 2 diabetes and weight management.

 

As previously disclosed, the team has out-licensed or transferred multiple novel drugs for liver diseases and NASH, and possesses extensive experience in leading new drugs from research and development through clinical trials to market launch.

 

Suzhou Taiwen Pharmaceutical Technology Co., Ltd. is located in the Suzhou Kunshan Biopharmaceutical Industrial Park and has established a research and development center in Shanghai Zhangjiang. Since its inception, the company has adhered to the philosophy of focusing exclusively on breakthrough and differentiated drugs, striving to become a high-tech biopharmaceutical company that delivers highly effective innovative medicines to patients.

 

Suzhou Taiwen Pharmaceutical Technology Co., Ltd. primarily targets the patient population with comorbid obesity and diabetes, focusing on developing differentiated, innovative consumer-grade novel drugs. VCT220, independently developed by Suzhou Taiwen Pharmaceutical, offers stable efficacy in glucose lowering and weight loss, along with advantages such as convenient administration and no dietary restrictions, compared to traditional injectable agents like liraglutide and semaglutide. The company plans to apply VCT220 in the treatment of type 2 diabetes, obesity, and non-alcoholic steatohepatitis (NASH). Clinical data for VCT220 have not yet been disclosed. This November, following Hengrui Medicine’s HRS-7535, Suzhou Taiwen Pharmaceutical has initiated the first Phase III clinical trial of its small-molecule GLP-1 receptor agonist VCT220, making it the second domestically produced small-molecule GLP-1R agonist in China to enter Phase III trials.

 

As of now, Taiwen Pharmaceutical has completed its Series B financing round; the specific amount raised has not been disclosed. The lead investor in this round was Shenzhen Capital Group (SCGC). According to information from Qichacha, Taiwen Pharmaceutical secured approximately RMB 100 million in Series A financing in February 2023, with joint investments from IDG Capital, Shenzhen Capital Group (SCGC), Longma Peak Venture Capital, and Galaxy Holding Group.

 

Regarding this transaction, Yanping Mu, Executive Director and Chief Executive Officer of CORXEL’s Board of Directors, stated, “Heart disease and stroke are the leading causes of death globally, and obesity is a major risk factor for cardiovascular and cerebrovascular diseases. Moreover, obesity has become a key risk factor for many chronic conditions, including diabetes, hypertension, and liver disease. This acquisition marks CORXEL’s expansion of its cardiometabolic pipeline into the fields of obesity and diabetes. We are encouraged by the significant weight-loss efficacy demonstrated by CX11, which holds the potential to become a best-in-class oral small-molecule GLP-1 receptor agonist (GLP-1 RA). Since its inception, CORXEL has demonstrated strong capabilities in innovative drug pipeline selection, clinical development, regulatory registration, and collaborative manufacturing. Our global team will fully accelerate the high-quality clinical development of CX11, positioning CORXEL to rapidly enter the vast global market for obesity treatments.”

 

“We are delighted that CORXEL will advance the global development of VCT220 (CX11). With its robust clinical development capabilities and global commercialization strength, we look forward to CORXEL accelerating clinical trials to bring this innovative oral GLP-1 medication to patients worldwide as soon as possible,” said Li Ben, CEO of Taiwen Pharmaceutical.

 

To date, 14 domestically developed small-molecule GLP-1R agonists in China have entered clinical development, with six undergoing Phase II trials and two (including VCT220) having advanced to Phase III.

 

Currently, more than 10 domestically developed small-molecule GLP-1 weight-loss drugs have entered clinical stages, including Hengrui Medicine’s HRS-7535, Taiwen Pharmaceutical’s VCT220, Chengyi Biopharma’s AZD5004, and Huadong Medicine’s HDM1002. Several of these pipelines have completed licensing deals. Notably, AstraZeneca invested over $2 billion to acquire the overseas rights to Chengyi Biopharma’s AZD5004. Additionally, Hengrui Medicine adopted the NewCo model for international expansion, granting U.S.-based Hercules Company a portfolio of three GLP-1 products, including the oral small-molecule GLP-1R agonist HRS-7535 and the dual GLP-1/GIP receptor agonist HRS9531, in a deal valued at up to $6 billion plus a 19.9% equity stake.