Latest news with #Jiangsu
Bloomberg
6 days ago
- Business
- Bloomberg
Hengrui's Obesity Drug Rivals Zepbound in Late-Stage China Trial
Jiangsu Hengrui Pharmaceuticals Co. and its US partner said their obesity drug candidate succeeded in a late-stage China study, a key step toward securing approval as domestic biotech firms increasingly challenge foreign rivals. Chinese patients taking the drug from Hengrui and Kailera Therapeutics lost up to 17.7% of their weight on average, the companies said in a statement this week. When adjusted for the placebo group, the drop in weight came in at 16.3% — a reduction comparable to what Eli Lilly & Co.'s Zepbound once showed in its China trial.
Yahoo
7 days ago
- Business
- Yahoo
Hengrui Pharma and Kailera Therapeutics Report Positive Topline Data from Phase 3 Obesity Trial in China of Dual GLP-1/GIP Receptor Agonist HRS9531
– Mean weight loss of 19.2% at 6 mg with no plateau in 48-week Phase 3 trial – – Favorable safety profile consistent with other GLP-1-based treatments – – Hengrui to submit NDA in China; Kailera plans to evaluate both higher doses and longer duration of treatment in global clinical trials – JIANGSU, China and WALTHAM, Mass., July 15, 2025 (GLOBE NEWSWIRE) -- Hengrui Pharma (Hengrui), a global pharmaceutical company focused on scientific and technological innovation, and Kailera Therapeutics, Inc. (Kailera), a clinical-stage biopharmaceutical company focused on advancing a broad pipeline of next-generation therapies for the treatment of obesity, today announced positive topline data from Hengrui's Phase 3 clinical trial (HRS9531-301) of once-weekly subcutaneous injection of HRS9531, a novel dual GLP-1/GIP receptor agonist, in individuals living with obesity or overweight in China (NCT06396429). The HRS9531-301 trial met both primary endpoints, including superior weight loss with HRS9531 (2 mg, 4 mg, and 6 mg) and greater percentage of participants achieving body weight reductions of at least 5% compared to placebo at 48 weeks. Hengrui plans to submit a New Drug Application (NDA) for chronic weight management in China, and Kailera is advancing HRS9531 as KAI-9531 to global clinical trials. The trial enrolled 567 participants with a mean baseline body weight of 93 kg (205 lb). Based on the primary analysis (treatment policy estimand)1, participants taking HRS9531 achieved a mean weight loss of up to 17.7% (16.3% placebo-adjusted). Additionally, up to 88.0% of HRS9531-treated participants achieved at least 5% weight loss, and 44.4% of participants achieved at least 20% weight loss. Based on the pre-specified supplementary analysis (hypothetical strategy estimand)2, participants taking HRS9531 achieved a mean weight loss of up to 19.2% (17.7% placebo-adjusted). The trial results demonstrated a favorable safety and tolerability profile consistent with GLP-1-based treatments and previously reported HRS9531 Phase 2 clinical data. Most treatment-emergent adverse events (TEAEs) were mild to moderate and gastrointestinal-related. In previously reported Phase 2 clinical trial results (NCT06054698), based on the primary analysis (treatment policy estimand)1, participants taking the 8 mg dose of HRS9531 achieved a mean weight loss of 22.8% (21.1% placebo-adjusted) at week 36, with no plateau in weight loss and a favorable safety profile consistent with other GLP-1-based treatments. Based on supplementary analysis (hypothetical strategy estimand)2, mean weight loss with the 8 mg dose of HRS9531 was 23.6% (21.7% placebo-adjusted). 'We are delighted to share the data from this landmark study. This is a huge step forward in providing innovative solutions to meet the needs of people living with obesity,' said Hong Chen, Head of Metabolism Department I of Hengrui Pharma. 'The positive data from the HRS9531-301 study demonstrated meaningful, sustained weight loss. With an affirmed safety and tolerability profile, we strongly believe in its potential to help more people living with obesity reach their individual weight loss goals. Based on these robust and encouraging clinical results, we are accelerating our efforts to advance this highly promising candidate. We look forward to filing for market approval in China as soon as possible to bring HRS9531 to patients struggling with obesity and overweight.' 'We commend our colleagues at Hengrui for these impressive Phase 3 clinical results, building on the strong momentum behind HRS9531 (KAI-9531). As Kailera prepares to advance KAI-9531 into a global clinical program, we look forward to evaluating both higher doses and longer duration of treatment to expand on KAI-9531's best-in-class potential,' said Ron Renaud, President and Chief Executive Officer, Kailera. 'Together with Hengrui, we believe KAI-9531 has tremendous potential to improve the lives of countless individuals worldwide, including those with higher BMIs who are seeking greater weight loss to achieve optimal health.' Hengrui intends to share the full HRS9531 Phase 3 clinical trial data at an upcoming scientific conference. About the HRS9531-301 Clinical TrialThe HRS9531-301 clinical trial was a multi-center, randomized, double-blind, placebo-controlled Phase 3 clinical study (NCT06396429) conducted by Hengrui in China to evaluate the efficacy and safety of HRS9531 injection in adults (≥18 years of age) with obesity (BMI ≥ 28 kg/m2) or overweight (BMI ≥ 24 kg/m2) and at least one weight-related comorbidity without diabetes. The study enrolled 567 participants with 531 completing the trial. The primary objective was to evaluate the efficacy of HRS9531 injection vs. placebo in reducing body weight after 48 weeks of treatment. Participants were randomized (1:1:1:1) to receive once-weekly subcutaneous injections of HRS9531 2 mg, 4 mg, 6 mg or placebo for 48 weeks. About HRS9531 (KAI-9531)HRS9531 is a novel injectable dual GLP-1/GIP receptor agonist formulated as an injectable peptide in clinical development for the treatment of type 2 diabetes, obesity and related conditions. Over 2,000 patients to date were dosed with HRS9531 across several Phase 1, Phase 2, and Phase 3 clinical trials in China. HRS9531 is being developed globally (ex-Greater China) by Kailera Therapeutics as KAI-9531. About Hengrui PharmaHengrui Pharma is an innovative, global pharmaceutical company dedicated to the research, development and commercialization of high-quality medicines to address unmet clinical needs. With a global R&D team that includes 14 R&D centers and more than 5,500 professionals, Hengrui Pharma's therapeutic areas of focus include oncology, metabolic and cardiovascular diseases, immunological and respiratory diseases, and neuroscience. To date, Hengrui has commercialized 23 new molecular entity drugs and 4 other innovative drugs in China. Founded in 1970 with the core principle of putting patients first, Hengrui Pharma remains committed to advancing human health by striving to conquer diseases, improve health, and extend lives through the power of science and technology. About Kailera TherapeuticsKailera Therapeutics (Kailera) is developing a broad, advanced, and differentiated portfolio of clinical-stage injectable and oral therapies for the treatment of obesity. Kailera's most advanced program, KAI-9531 (being developed in China as HRS9531), is an injectable dual GLP-1/GIP receptor agonist that has demonstrated positive results in clinical trials in obesity and type 2 diabetes in China. The Company is also advancing a diversified pipeline leveraging several mechanisms and routes of delivery, including oral administration. Kailera's mission is to develop next-generation weight management therapies that give people the power to transform their lives and elevate their overall health. The Company is based in Waltham, MA and San Diego, CA. For more information, visit and follow us on LinkedIn and X. 1 Based on the treatment policy estimand (primary statistical analysis): treatment effect regardless of treatment adherence2 Based on the hypothetical strategy estimand (supplementary statistical analysis): treatment effect excluding the occurrence of intercurrent events Contact Information Contact Information for Hengrui DGA Group hengrui@ Contact Information for KaileraMaura GavaghanVice President, Corporate Communications and Investor
South China Morning Post
15-07-2025
- Health
- South China Morning Post
‘China's Ozempic' pioneer inks deal with JD Health for online distribution
China's weight loss drugs market could grow to US$5.6 billion by 2035, according to Goldman Sachs Innovent Biologics, the first Chinese company to win regulatory approval to sell a GLP-1 drug for weight loss and diabetes, will leverage JD Health's online distribution network as it seeks to grab a slice of a market that could be worth 40 billion yuan (US$5.6 billion) in a decade. The companies will collaborate on supply chain and sales channel development ahead of Innovent's launch of mazdutide, as well as engage in a consumer education campaign. 'Innovent and JD Health will join hands to popularise knowledge about weight loss and blood sugar control via on and offline channels,' Innovent said in a statement posted on its WeChat account on Tuesday. Late last month, eastern Jiangsu province-based Innovent said it received Chinese regulatory approval for mazdutide, which it claimed was the world's first to mimic the natural hormones of GLP-1 and glucagon, with the latter playing a crucial role in regulating blood glucose levels. GLP-1 drugs mimic the actions of the naturally produced hormone glucagon-like peptide-1, which regulates blood sugar levels, suppresses appetite and slows digestion. A woman injects insulin with an insulin pen to treat her diabetes at home. Photo: Shutterstock Images 'Innovent will make its breakthrough dual-target, liver fat-reducing weight loss therapy available to obese patients as soon as possible, to contribute towards the weight management and healthy China initiatives,' said chairman Michael Yu Dechao, without giving a time frame. Some 34.3 per cent of mainland Chinese adults were estimated to be overweight and 11.2 per cent were obese, according to a 2022 study involving nearly 63,000 participants in 10 provinces. The results were published in 2024 by Public Health, a peer-reviewed journal. Newsletter Every Saturday SCMP Global Impact By submitting, you consent to receiving marketing emails from SCMP. If you don't want these, tick here {{message}} Thanks for signing up for our newsletter! Please check your email to confirm your subscription. Follow us on Facebook to get our latest news. Over 70 per cent of the population would be overweight or obese by 2030, and if the problem was not addressed effectively, it would consume 22 per cent of the nation's total healthcare budget, according to the National Health Commission. Last April, Beijing launched a nationwide weight management campaign as part of its 'healthy China' 2019-2030 action plan, saying obesity had become 'a major public health threat'. China's weight loss drugs market could grow to 40 billion yuan in 2035, according to Chen Ziyi, Goldman Sachs' head of Asia healthcare research. Currently, sales are primarily driven by Denmark-based Novo Nordisk, which reported US$285 million in GLP-1 drug sales for diabetes in China in the first quarter, and US$11 million in sales for weight loss applications. Dozens of Chinese firms are conducting clinical trials on both generic and novel alternatives. Globally, industry estimates for sales of anti-obesity drugs range from US$100 billion to US$150 billion by 2035. JD Health's cold storage facilities in some 300 cities across the mainland could meet Innovent's requirement for GLP-1 drugs to be stored at 2 to 8 degrees Celsius when in transit, Innovent said. Innovent, among the first batch of biotech firms that went public in Hong Kong in 2018, has since launched 16 novel drugs for various types of cancer, as well as for autoimmune, metabolic and eye diseases. Beijing-based JD Health operates one of China's largest online healthcare platforms, with 183.6 million annual active users and an average daily online medical consultation volume of 490,000 last year. Its distribution network spans over 100,000 third-party merchants. Last year, JD Health helped multiple global pharmaceutical firms distribute new drugs in China, including US-based Eli Lilly's GLP-1 diabetes and weight loss drug tirzepatide, a rival to Novo Nordisk's semaglutide. Semaglutide is formulated and marketed as Ozempic for diabetes and Wegovy for weight loss.
South China Morning Post
15-07-2025
- Business
- South China Morning Post
‘China's Ozempic' pioneer inks deal with JD Health for online distribution
Innovent Biologics, the first Chinese company to win regulatory approval to sell a GLP-1 drug for weight loss and diabetes, will leverage JD Health's online distribution network as it seeks to grab a slice of a market that could be worth 40 billion yuan (US$5.6 billion) in a decade. The companies will collaborate on supply chain and sales channel development ahead of Innovent's launch of mazdutide, as well as engage in a consumer education campaign. 'Innovent and JD Health will join hands to popularise knowledge about weight loss and blood sugar control via on and offline channels,' Innovent said in a statement posted on its WeChat account on Tuesday. Late last month, eastern Jiangsu province-based Innovent said it received Chinese regulatory approval for mazdutide, which it claimed was the world's first to mimic the natural hormones of GLP-1 and glucagon, with the latter playing a crucial role in regulating blood glucose levels. GLP-1 drugs mimic the actions of the naturally produced hormone glucagon-like peptide-1, which regulates blood sugar levels, suppresses appetite and slows digestion. A woman injects insulin with an insulin pen to treat her diabetes at home. Photo: Shutterstock Images 'Innovent will make its breakthrough dual-target, liver fat-reducing weight loss therapy available to obese patients as soon as possible, to contribute towards the weight management and healthy China initiatives,' said chairman Michael Yu Dechao, without giving a time frame.
South China Morning Post
13-07-2025
- Business
- South China Morning Post
China's luxury hotels sell street food to survive tough business climate
Catering at luxury hotels typically involves high-end banquets and formal entertainment, with exquisite decor and masterfully crafted dishes often seen as worth the high price tag. But for many consumers in China, that is changing. In July, the five-star Zhongwu Hotel in Changzhou, Jiangsu province – ranked second among 10 luxury hotels in the city on – surprised observers when it launched a street vendor service offering budget meal boxes prepared by its catering team. 'You must first solve the problem of survival. If you can't even solve your own problems, what else can you talk about?' said Chen Yonghua, Zhongwu Hotel's manager. The decision reflects a sluggish business environment for China's high-end hospitality sector, as cautious consumers tighten their belts amid concerns about a slowing economy. Priced between 20 yuan and 100 yuan (US$3 and US$14), the boxed meals are a far cry from the several thousand typically charged for a banquet table. Offerings include popular night market favourites like braised dishes, spicy crayfish, a selection of dim sum and other delicacies.
