Latest news with #KaileraTherapeutics
Yahoo
16-07-2025
- Health
- Yahoo
Hengrui and Kailera report positive data from Phase III obesity treatment trial
Hengrui Pharma and Kailera Therapeutics have reported positive topline data from the former's Phase III trial (HRS9531-301) of subcutaneous injections of HRS9531 once per week in those with obesity or who are overweight in China. The HRS9531-301 study targeted adults with obesity or who were overweight and had a minimum of one weight-related comorbidity, excluding those with diabetes. Subjects were randomly assigned and given HRS9531 at doses of 2mg, 4mg, 6mg, or a placebo for a 48-week period. Out of the 567 enrolees, 531 completed the study. The double-blind, randomised, placebo-controlled multi-centre trial has met its primary endpoints. Participants who received the dual glucagon-like peptide-1/glucose-dependent insulinotropic polypeptide (GLP-1/GIP) receptor agonist, HRS9531, at these doses experienced significantly more weight loss than those who took a placebo during the 48-week timeframe. The 567 individuals in the trial had a mean baseline body weight of 93kg. The primary analysis showed that those treated with HRS9531 achieved a mean weight loss of up to 17.7%, with the placebo-adjusted figure being 16.3%. In addition, the trial showed that up to 88% of those treated with HRS9531 lost at least 5% of their body weight, and 44.4% achieved a weight reduction of at least 20%. A pre-specified supplementary analysis showed a mean weight loss of up to 19.2%, with a placebo-adjusted figure of 17.7%. The safety profile of HRS9531 was favourable, aligning with GLP-1-based therapies and consistent with previous Phase II clinical data. Hengrui is now preparing to submit a new drug application in China for chronic weight management while Kailera is set to expand the therapy, as KAI-9531, into worldwide trials. Kailera Therapeutics CEO and president Ron Renaud said: 'We commend our colleagues at Hengrui for these impressive Phase III clinical results, building on the strong momentum behind HRS9531 (KAI-9531). 'As Kailera prepares to advance KAI-9531 into a global clinical programme, we look forward to evaluating both higher doses and longer duration of treatment to expand on KAI-9531's best-in-class potential.' HRS9531 is under development to treat type 2 diabetes and conditions related to obesity. Earlier this year, both companies reported encouraging topline data from a Phase II obesity trial involving an 8mg dose of HRS9531. "Hengrui and Kailera report positive data from Phase III obesity treatment trial" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Bloomberg
16-07-2025
- 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
15-07-2025
- 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
Reuters
15-07-2025
- Health
- Reuters
Kailera touts late-stage win for weight-loss drug in China
July 15 (Reuters) - U.S.-based Kailera Therapeutics and Chinese firm Jiangsu Hengrui Pharmaceuticals' ( opens new tab experimental weight-loss drug has helped overweight patients lose up to 17.7% of body weight in a late-stage study in China, the companies said on Tuesday. Up to 88% of participants who received the drug, known as KAI-9531 outside China, lost at least 5% of their weight after 48 weeks compared to placebo, meeting the study's main goals. The data comes at a time when U.S. drugmakers are increasingly looking to China to secure the rights to promising drug candidates at a lower cost and access important early data that could pave the way for global trials. "As we think about commercial opportunity, this is a really good first look as to what we think we're going to be able to leverage in terms of (obesity treatment) marketplace going forward," Kailera CEO Ron Renaud said. The startup was launched last year with a rare $400 million early-stage funding and four obesity drug candidates licensed from Hengrui, in a move to grab a slice of the obesity treatment market primed to be worth $150 billion by the end of the decade. KAI-9531, administered as a weekly injection, belongs to a the GLP-1 class of treatments that include Eli Lilly's (LLY.N), opens new tab Zepbound and Novo Nordisk's ( opens new tab Wegovy. The drugs work by helping control blood sugar levels and triggering a feeling of fullness. "Where we're really focused is where weight loss matters most, which is in people living with higher BMIs (body mass index)," Chief Commercial Officer Jamie Coleman said. "Today's a lot of clinical need on the table for people who need to lose more than 20% (of weight)." In the study that included 567 participants, a six-milligram dose of the drug led to an average weight loss of 17.7% compared to placebo. The companies said the side effects were mild to moderate and gastrointestinal-related, consistent with similar treatments. Hengrui plans to seek regulatory approval in China, while Kailera will pursue global trials with higher doses and extended treatment durations. Earlier this year, an eight-milligram dose of the drug led to an average weight loss of 22.8% in a mid-stage trial.
Forbes
14-04-2025
- Business
- Forbes
Forbes Daily: U.S. Dollar Slips Ahead Of Weekend Trade Whiplash
The weight loss drug market has exploded, and Kailera Therapeutics is coming for its leaders, Novo Nordisk and Eli Lilly. The firm has licensed four promising obesity therapies from China, which is emerging as a pharmaceutical research and development powerhouse. And having ready-made drugs should enable Kailera to move fast in an increasingly competitive market. Global sales of weight loss drugs swelled 50% last year and could more than triple again by 2028, research shows. 'We have probably the most advanced, diverse, late-stage pipeline that is focused exclusively on weight management, outside of Big Pharma,' says Ron Renaud, the all-star former biotech stock analyst hired to run the company. Treasury Secretary Scott Bessent (2nd R) and Commerce Secretary Howard Lutnick look on as President Donald Trump speaks after signing an executive order in the Oval Office of the White House on April 9, 2025 in Washington, D.C. After the Trump Administration's trade policy for electronics shifted multiple times over the weekend, China's President Xi Jinping criticized Trump's tariffs and called for the protection of 'the multilateral trading system' in an op-ed as the Chinese leader seeks allies. Xi met with Spanish Prime Minister Pedro Sanchez Friday and urged the EU to 'oppose unilateral bullying practices,' and is wrapping up a diplomatic visit in Vietnam where he made a similar case. Investors are turning to safe havens as President Donald Trump's tariffs shake up the global markets, but their preferences are shifting. Gold prices hit a new record Friday, but the U.S. dollar fell to its lowest level since April 2022. 'What is potentially being compromised is the post-World War II order of international finance where the dollar has been the central pillar' of the global economy, said Bhanu Baweja, UBS Investment Bank's chief strategist. Consumer sentiment has taken a hit from the uncertainty over Trump's tariffs, falling to its lowest level in nearly three years this month, according to a recent University of Michigan survey. The survey shows consumer sentiment down 30% in April compared to where it stood at the end of the Biden Administration in January. Trump's trade war could have an impact on the president's constellation of foreign properties, as the tourism industry, which is already showing cracks, could slow down worldwide. But as he paused his latest levies, all 13 countries where Trump does business have signaled at least some willingness to negotiate with the U.S. ANDREJS ZAVADSKIS FOR FORBES Dutch billionaire Remon Vos, a newcomer to Forbes' 2025 World's Billionaires List, has grown his firm CTP into the second-largest industrial and logistics real estate developer in Europe, earning him a fortune worth an estimated $5.9 billion. And the company is likely to benefit from tariffs in the long term, as companies who want to sell to Europe will have to build their factories there to avoid higher import duties. The fintech industry's adoption of AI has been slow as a result of regulatory and compliance hurdles, but a new trend is emerging: using AI for deep investment research. It's still hard to tell which early-stage startup will live up to the hype, but they're all addressing labor-intensive tasks where improvements are long overdue. Tesla appeared to remove a feature on its website in China allowing customers to purchase two car models the company imports from the U.S. as the trade war between the two countries escalates. The company's Model S sedan and Model X SUV are produced at a factory in Fremont, California, though the 'Order Now' button is still accessible for Tesla's Model 3 and Model Y vehicles, as they are assembled in Shanghai. Commerce Secretary Howard Lutnick is a key public face of Donald Trump's trade policies, and those who know him say he's 'like a pig in s***.' But among the wealthy members of Trump's cabinet, no one seems to have more on the line than the former Wall Street executive: The value of his holdings, which he appears to be handing off to his heirs, plunged $420 million in the last week, according to Forbes estimates, dropping his family fortune from $3.2 billion to $2.7 billion. ANDREW HARNIK/GETTY IMAGES When Sevonna Brown learned that Elon Musk's quasi-governmental agency DOGE had ordered payment stopped on her more than $2 million NIH grant for maternal community healthcare, she started hitting the phones. The network of services for mothers and children that Brown had spent more than a decade building was coming to a screeching halt. Given Musk's endless warnings that falling birthrates pose an existential threat to civilization, DOGE's abrupt gutting of maternal health services is simultaneously ironic, and exactly what you'd expect from an effort whose blunders far exceed its claimed, but typically unverifiable, achievements. Musk has donated millions of dollars to fund research on fertility. But at this point, he has taken much more from pregnant women and new mothers than he has given. In February, DOGE threatened a seven-year, $168 million NIH initiative to improve maternal health across the state of Michigan. It suspended more than $27 million in grants to women's health centers, laid off federal workers running programs for expecting mothers on Medicaid, and cancelled $1.6 million in funding for maternal and postpartum care at the Morehouse School of Medicine in Atlanta. 'We can't claim to care about birthrates while defunding the very systems that make pregnancy, birth and parenting safe,' says Emilie Rodriguez. A medical anthropologist, doula, and co-founder of The Bridge Directory, a group of perinatal maternal healthcare providers, Rodriguez worked with Sevonna Brown on the CHAMP Center of Excellence grant. WHY IT MATTERS 'The Department of Government Efficiency is supposed to be about cutting fat from the federal budget,' says Forbes senior writer Emily Baker-White. 'Here, it's cutting out vital organs: medical interventions that save lives and help pregnant women have children safely.' MORE Elon Musk Is A Billionaire Federal Welfare Vampire It's been a volatile time for investors since President Donald Trump's tariff 'Liberation Day,' as the S&P 500 netted a more than 5% loss from April 2 through Friday. But some stocks have performed better than others: 90%: The share of stocks on the S&P 500 that declined during that period 50: The number of above-water stocks in that time, dominated by healthcare stocks as well as bargain retailers and defense contractors 34%: The drop in pharmaceutical developer Charles River Laboratories' stock, making it the worst performing on the S&P since April 2 Investors are reeling from the fallout over President Donald Trump's tariffs, and while it's typical to take a 'wait-and-see' approach, proactively navigating the uncertainty is possible for those who are patient and forward-thinking. Leaders should absorb that anxiety without passing it on. A manager's ability to guide their team through turbulence and provide support for employees can help improve overall well-being. President Donald Trump instituted tariffs in the hopes of bringing manufacturing back to the U.S., but some products, including certain spices, can't be produced here. Around 80% of America's vanilla supply comes from which country? A. Mexico B. Indonesia C. Madagascar D. India Check your answer. Thanks for reading! This edition of Forbes Daily was edited by Sarah Whitmire and Chris Dobstaff.
