HRS-9531

FDA Tightens Requirements for China-Developed Drugs, Mandates Multi-Regional Trials

3 months ago

• The FDA has rejected multiple China-developed drugs, including Hutchmed's surufatinib and Eli Lilly's sintilimab, citing concerns over single-country clinical trial data. • At least 25 oncology drug applications from China face increased scrutiny, with the FDA emphasizing the need for multi-regional trials to ensure data generalizability across diverse populations. • The regulatory shift impacts China's growing biopharma sector, which has attracted significant Western partnerships, including Merck's recent $1.4 billion deal with Sichuan Kelun Pharmaceutical.

Kailera Therapeutics Strengthens Commercial Leadership with Ex-Lilly Executive Jamie Coleman Ahead of Phase 3 Obesity Drug Program

4 months ago

• Kailera Therapeutics has appointed Jamie Coleman, former Eli Lilly Vice President and Zepbound® Brand Leader, as Chief Commercial Officer to spearhead commercialization strategy for their obesity drug pipeline. • Coleman brings 25 years of healthcare experience, including successful launches of blockbuster drugs like Zepbound®, Trulicity®, and Jardiance®, strengthening Kailera's position in the competitive obesity therapeutics market. • The appointment comes as Kailera prepares to advance its lead candidate KAI-9531, a GLP-1/GIP receptor dual agonist, into global Phase 3 clinical trials for obesity treatment.

Kailera's HRS9531 Shows Strong Phase II Weight Loss, Pfizer Cautious on Danuglipron

4 months ago

• Kailera Therapeutics' HRS9531, a dual GLP-1/GIP receptor agonist, demonstrated a 21.1% placebo-adjusted weight reduction in Phase II trials over 36 weeks. • Pfizer CEO Albert Bourla expressed caution regarding their oral obesity candidate, danuglipron, despite plans for late-stage studies of the once-daily formulation. • Kailera reported that 59% of patients on HRS9531 achieved at least 20% body weight loss, with no plateau observed, suggesting potential for greater efficacy with longer use. • Pfizer abandoned a twice-daily danuglipron formulation due to toxicities, focusing on a once-daily version, but analysts remain divided on its prospects in the competitive obesity market.

Hengrui Pharma's HRS9531 Shows Promising Weight Loss in Phase 2 Obesity Trial

5 months ago

• Hengrui Pharmaceuticals and Kailera Therapeutics reported positive Phase 2 results for HRS9531, a GLP-1/GIP receptor dual agonist, in overweight or obese adults. • Participants receiving the 8 mg dose of HRS9531 achieved a statistically significant 21.1% placebo-adjusted mean weight loss at 36 weeks. • The trial demonstrated a favorable safety profile, with most adverse events being mild and gastrointestinal-related during dose titration. • Hengrui is advancing HRS9531 into Phase 3 clinical trials for obesity and type 2 diabetes in China, with Kailera developing it globally as KAI-9531.

Oral GLP-1R Obesity Drugs Race to Market as Novo Nordisk and Eli Lilly Lead Phase III Trials

6 months ago

• Four oral GLP-1 receptor (GLP-1R) agonists are in Phase III trials, signaling a shift in obesity treatment from injectables to more convenient oral options. • Novo Nordisk's Rybelsus, already approved for type 2 diabetes and cardiovascular risk, is being evaluated for obesity, with NN-9932 expected to launch by 2025. • Eli Lilly's orforglipron calcium aims to be the first oral GLP-1R approved for obesity, with a projected launch in 2026, potentially expanding the company's market dominance. • Jiangsu Hengrui’s HRS-9531 marks the entry of a China-based company into the competitive GLP-1R market, challenging the dominance of established pharmaceutical giants.

Kailera Therapeutics Launches with $400M to Advance GLP-1 Based Obesity Therapies

8 months ago

• Kailera Therapeutics emerges with $400 million in Series A funding to develop next-generation GLP-1 therapies for obesity and related metabolic conditions. • The company's lead asset, KAI-9531, a dual GLP-1/GIP receptor agonist, has demonstrated promising Phase 2 results in obesity and type 2 diabetes. • Kailera's portfolio, licensed from Jiangsu Hengrui Pharmaceuticals, includes injectable and oral GLP-1 agonists, with plans to expand treatment options. • Led by CEO Ron Renaud and backed by prominent investors, Kailera aims to innovate beyond current market leaders in the rapidly evolving metabolic space.