Latest news with #Kailera
CNBC
16-07-2025
- Business
- CNBC
Healthy Returns: Chinese obesity drug emerges as a potential rival to Eli Lilly's Zepbound
Another potential competitor to blockbuster obesity treatments from Eli Lilly and Novo Nordisk just showed positive data – but this time, it's from China. An experimental weekly injection developed by Chinese drugmaker Hengrui Pharma and its U.S.-based partner, Kailera Therapeutics, succeeded in a late-stage trial in China, putting the drugmakers on track to seek approval there. Kailera is among several companies, such as Merck, Novo Nordisk and Regeneron, that have tapped the Chinese market in search of a drug that could win a slice of the booming weight loss drug market. In May 2024, Kailera licensed rights outside of the Greater China region to multiple experimental drugs from Hengrui in return for more than $100 million in upfront and near-term payments, a 20% equity stake and nearly $6 billion in future milestones. Here's how the drug, dubbed HRS9531, performed in the trial: It helped patients lose nearly 18% of their body weight on average after 48 weeks, which is more than 16% greater weight loss than those on a placebo saw. Almost 9 in 10 people who received the injection lost at least 5% of their body weight, and 44.4% of patients achieved at least 20% weight loss, according to a release from the companies. There was no plateau in weight loss at 48 weeks. The companies didn't disclose specific safety data or how well patients tolerated the drug, only saying those results were consistent with previous data on the treatment and other GLP-1s. Most adverse events from the injection were gastrointestinal-related and mild to moderate in severity, the companies said. Hengrui will file an approval application for the drug in China. Meanwhile, Kailera will start global studies that use higher doses and keep patients on the treatment for longer, the startup's CEO Ron Renaud said in the release. It will likely still take several years before HRS9531 enters the market, particularly in the U.S. and other nations outside of China. But the drug's results appear to be promising, and position it as a potential competitor to Eli Lilly's weekly weight loss injection Zepbound. Both drugs work by activating two naturally produced hormones in the body: glucagon-like peptide-1, known as GLP-1, and glucose-dependent insulinotropic polypeptide, or GIP. The combination is said to slow the emptying of the stomach, making people feel full for longer and suppressing appetite by slowing hunger signals in the brain. Across two phase three trials enrolling roughly 3,000 adults with obesity or Type 2 diabetes, Zepbound helped patients lose an average of up to 21% of their body weight over 72 weeks. It's difficult to directly compare results from different clinical trials, especially since the latest results on HRS9531 were only from more than 500 patients. But the drug still achieved significant weight loss over 48 weeks, raising hopes about its potential over a longer period of time. Meanwhile, Novo Nordisk's weekly injection Wegovy only targets GLP-1. Feel free to send any tips, suggestions, story ideas and data to Annika at Well folks, after a long saga, Anne Wojcicki has officially regained control of the embattled genetic testing company 23andMe. Wojcicki co-founded 23andMe and served as CEO until the company filed for Chapter 11 bankruptcy protection in March. Her new nonprofit, TTAM Research Institute, has completed its acquisition of the Personal Genome Service and Research Services business lines of 23andMe, the company announced on Monday. "As part of TTAM, 23andMe is continuing to operate and provide customers with personalized DNA testing and research services," the company said in a release. "TTAM is committed to providing customers with choice and transparency with their data, including the option to change their decision on whether to participate in research." TTAM is an acronym for the first letters of 23andMe, according to The Wall Street Journal. 23andMe rocketed into the mainstream with at-home DNA testing kits that gave customers insight into their family histories and genetic profiles. But the five-time CNBC Disruptor 50 company struggled to generate recurring revenue and stand up viable research and therapeutics businesses after going public. When it became clear that 23andMe's financials were shaky, Wojcicki submitted several proposals to take the company private while she was still its chief executive. Those plans were unsuccessful, and she ultimately had to compete against other prospective buyers in a bankruptcy auction. And, of course, there were some unexpected twists. In May, Regeneron Pharmaceuticals announced it would purchase most of 23andMe's assets for $256 million after it came out on top during the bankruptcy auction. But Wojcicki submitted a separate $305 million bid through TTAM and pushed to reopen the auction. A month later, she did just that, and TTAM announced that it had successfully outbid Regeneron. "I am thrilled that TTAM Research Institute will be able to continue the mission of 23andMe to help people access, understand and benefit from the human genome," Wojcicki said in a June statement. Feel free to send any tips, suggestions, story ideas and data to Ashley at
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
Mint
16-07-2025
- Business
- Mint
Lilly's Zepbound faces a potential weight-loss rival. It's made by a Chinese biotech
A new late stage trial of a promising weight loss drug is one more sign of the impending disruption the booming Chinese biotech industry could bring to US biopharma. A Chinese-developed weight loss shot looked almost as good as Eli Lilly's megablockbuster Zepbound in late-stage trial results rolled out Tuesday morning, in one more sign of the impending disruption that the booming Chinese biotech industry could bring to U.S. biopharma. The Jiangsu, China-based company Hengrui Pharma and its privately held U.S. partner Kailera Therapeutics said early Tuesday that patients lost an average of 18% of their weight over 48 weeks on Hengrui's drug, HRS9531. Using a statistical measure that only takes into account patients who completed the trial, their average weight loss was 19%. That's still not quite as good as Zepbound, which led to 21% weight loss in a late-stage trial. But the Zepbound trial was longer, and Hengrui and Kailera say that patients were still losing weight when the Hengrui trial ended. What's more, the latest Hengrui trial didn't study HRS9531 at its highest dose level. Hengrui plans to seek regulatory approval for the shot in China only 'as soon as possible" based on the new results. The drug won't pose a threat to Lilly anytime soon, if ever. But Kailera, the U.S. company that licensed the rights to HRS9531 outside of China, thinks they may be able to show it works better than Zepbound in their own trials, which have yet to start, and which are aimed at getting global approvals for the drug. 'Today's treatments are pretty much capped at about 20%" weight loss, said Kailera's chief commercial officer, Jamie Coleman, in an interview Tuesday with Barron's. 'Our goal is to maximize that efficacy, go beyond that." Even if Kailera eventually does show that HRS9531 can help patients lose more weight than Zepbound, the drug is years from U.S. approval, and would likely launch later than retatrutide, a follow-up medicine from Lilly that already works better than Zepbound. Lilly's hold on the weight loss market seems secure at least until the end of the decade, if not longer. Still, the promising data on HRS9531 is a hint at the challenges that Chinese biotech is increasingly posing for U.S. biopharma. As Barron's reported in June, U.S. drugmakers have spent tens of billions of dollars in recent months acquiring rights to experimental medicines invented by Chinese companies, in a sign of the growing quality and efficiency of the Chinese biotech sector. HRS9531 is one of a big group of Chinese-developed weight loss assets licensed by U.S. companies. Merck licensed an oral GLP-1 for $112 million up front in December of last year from Hansoh Pharma, and Regeneron licensed a GLP-1/GIP from the same company in June for $80 million up front. AstraZeneca, Lilly, and Novo Nordisk also have similar deals with other companies. It all adds complexity for investors trying to forecast the shape of the obesity market over the long term. And it's a potential threat to the U.S. biotech ecosystem, which relies on big pharma cash going to U.S. biotechs to fund development of new drugs. HRS9531, which Kailera calls KAI-9531, is very similar to Lilly's Zepbound: Both are dual GLP-1/GIP receptor agonists, and both are injectable peptides. In an earlier trial, also conducted by Hengrui, patients on a higher dose of HRS9531 lost 22.8% of their weight after 36 weeks. 'Generally speaking, what we've seen out of China so far, this data looks very similar to tirzepatide," said Coleman, using Zepbound's chemical name. 'We can go to higher doses without trading off tolerability, and we'll study it longer." Though the latest study was a Phase 3 trial, it only enrolled 567 patients, far fewer than would be needed in a U.S. Phase 3. Kailera launched in October with $400 million in private funding. It owns the rights outside of China to four Hengrui drugs including HRS9531. The question for Kailera is what the market would be for a drug that may be similar or a bit better than Zepbound, and how the biotech could ramp up manufacturing. Making significant quantities of the drug has been a challenge for Lilly, which has invested many billions of dollars in expanding its manufacturing capacity. Coleman, who was vice president, U.S. brand leader for Zepbound at Lilly before coming to Kailera, said that Kailera is already talking to contract manufacturers, and that more contract manufacturing capacity is available because Lilly and its competitor Novo Nordisk have brought much of their manufacturing in-house. 'We intend to focus and compete where weight loss matters the most, and where there are unmet needs in the market," Coleman said. 'There's a high level of unmet need in people that need to lose more than what tirzepatide today is providing. And there are very few molecules that are really set up to deliver higher efficacy, especially with a mechanism that is well-known, well-understood, and a tolerability profile that's pretty well accepted." Write to Josh Nathan-Kazis at
Yahoo
05-06-2025
- Business
- Yahoo
Kailera Therapeutics Appoints Adam Koppel and Christopher Hite to Board of Directors
BOSTON and SAN DIEGO, June 05, 2025 (GLOBE NEWSWIRE) -- Kailera Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on advancing a broad pipeline of next-generation therapies for the treatment of obesity and related conditions, today announced the appointments of Adam Koppel and Christopher Hite to its Board of Directors. 'We are thrilled to welcome Adam and Chris to our Board of Directors. Their extensive track records as respected advisors to biopharma companies on corporate and financial strategy will be incredibly valuable as we continue to execute on our mission to advance next-generation therapies for the treatment of obesity,' said Ron Renaud, President and Chief Executive Officer, Kailera. 'It's an exciting time to join Kailera's Board as they progress their pipeline toward late-stage global trials, and I look forward to contributing to the company's continued success and long-term value creation,' said Dr. Koppel. Mr. Hite added, 'I am pleased to join the Board of Kailera at this important time of innovation in the obesity space that has positively impacted millions of patients worldwide. Kailera has a clear strategy to advance their diversified pipeline, and I look forward to supporting the leadership team as they work towards achieving their mission.' Dr. Koppel is a distinguished investor and strategic leader with more than 25 years of biopharmaceutical industry experience. He is a Partner on Bain Capital's Life Sciences team and initially joined Bain Capital in 2003. Previously, Dr. Koppel was EVP of Corporate Development and Chief Strategy Officer at Biogen. He currently sits on the Board of Directors of Areteia Therapeutics and Cardurion Pharmaceuticals and serves on the Board of Trustees at Newton Wellesley Hospital. Dr. Koppel also co-chairs the Harvard Medical School Discovery Council and serves on the Mass General Brigham Innovation Growth Board. He received an M.D. and Ph.D. in Neuroscience from the University of Pennsylvania School of Medicine. Dr. Koppel also received an M.B.A. from The Wharton School at the University of Pennsylvania, where he was a Palmer Scholar, and graduated magna cum laude from Harvard University with an A.B. and A.M. in History and Science. Mr. Hite, a seasoned financial executive with over 25 years of financial and strategic experience in the biopharmaceutical industry, will serve as an independent board member and audit committee chair. Mr. Hite currently serves as Executive Vice President and Vice Chairman at Royalty Pharma. Prior to joining Royalty Pharma in 2020, he was at Citibank for over a decade, serving most recently as Vice Chairman of Banking, Capital Markets and Advisory (BCMA) and a member of the BCMA Executive Committee, and previously as the Global Head of Healthcare Investment Banking. Prior to joining Citibank, Mr. Hite was the Global Head of Healthcare Investment Banking at Lehman Brothers. He serves on the Board of Trustees at Lehigh University, the Board of Advisors of Faster Cures, a center of the Milken Institute, and served on the Board of Directors of Acceleron Pharma Inc. until its acquisition by Merck in November 2021. Mr. Hite has a B.S. from Lehigh University, and a J.D. and M.B.A. from the University of Pittsburgh. About Kailera Therapeutics Kailera Therapeutics (Kailera) is developing a broad, advanced, and differentiated portfolio of clinical-stage injectable and oral therapies for the treatment of obesity and related conditions. Kailera's most advanced program, KAI-9531 (being developed in China as HRS9531), is an injectable GLP-1/GIP receptor dual agonist that has demonstrated positive results in Phase 2 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. Contact Information Maura Gavaghan Vice President, Corporate Communications and Investor Relations while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
Forbes
12-04-2025
- Business
- Forbes
Why These Investment Firms Bet $400 Million On A Chinese Ozempic Rival
Serial Salesman: Kailera CEO Ron Renaud has built and sold three biotechs, the last for $8.7 billion. 'Companies get bought, they don't get sold,' he says. But the obesity market's frenzy could make Kailera a prime acquisition target. In the summer of 2023, Dr. Amir Zamani, a 42-year-old Johns Hopkins–trained physician who is a partner on Bain Capital's life sciences team in Boston, was obsessed with obesity drugs. Ozempic, the blockbuster injectable for type 2 diabetes from Novo Nordisk, was taking America by storm, on pace to generate some $14 billion in revenue that year for the Danish pharmaceutical giant. Eli Lilly was nearing FDA approval for its similar weight loss drug, Zepbound. Zamani eagerly wanted to find a competitor. He'd been reading the early research for two years and spent months digging through reams of data from dozens of companies. Then he struck gold in an unexpected place: the portfolio of Jiangsu Hengrui Pharmaceuticals, one of China's biggest pharmaceutical companies. Showcased in the early clinical data before him was a potential next-generation injectable weight loss therapy that, like Ozempic and Zepbound, targeted the blood sugar and appetite regulating hormone GLP-1. 'It was like, 'Wait a second, they're ahead of everybody else who's not Novo or Lilly,' ' he says. Results from Phase II clinical trials in China ultimately showed 59% of participants lost 20% or more of their body weight on an eight-milligram dose of the drug in 36 weeks, and side effects were mild. If those results hold, the drug could be especially useful for severely obese patients who need to lose more weight than they can on currently available medications. Better yet, it was available to license. 'We said, 'Gosh, this looks like it's really a best-in-class therapy,' ' Zamani recalls, noting that the portfolio also included three other drugs, two of them more easily administered pills. 'Then we got very serious.' It used to be that Chinese drug development was largely about creating 'me too' drugs for the local market. But over the past 10 years, with Beijing focused on building a native biotech industry, U.S.-trained Chinese scientists returned home and started innovating instead of mimicking. A January report by Stifel analyst Tim Opler noted that nearly one-third of molecules sourced by major pharmaceutical companies through licensing deals are coming from China. American outfits have spent $8.1 billion on upfront payments for Chinese drugs between 2020 and 2024, compared to $536 million in the preceding five years, according to biopharma deals database DealForma. While U.S. regulations have cracked down on investment in Chinese companies, there are minimal restrictions on U.S. companies buying or licensing pharmaceutical assets created there. 'When new biology hits or new sets of targets become proven, then suddenly everyone who wants one of those just goes shopping in China,' says Jory Bell, a general partner at VC firm Playground Global. From HIV to GLP-1: John Milligan, Gilead's former CEO and Kailera's chairman, has been amazed by studies showing obesity drugs' benefits beyond weight loss. 'It shows how important metabolic health is to longevity,' he says. Zamani wasted no time with the obesity drug, quickly partnering with Cambridge, Massachusetts–based VC shop Atlas Venture and New York's RTW Investments. The three firms invested $400 million to spin up Kailera Therapeutics in October, launching with a license for the four Hengrui therapies and a plan to shepherd them to market. Having a ready-made portfolio of four drugs should allow Kailera to move fast in a space that has become extremely competitive since Ozempic became a household name. Global sales of the category ballooned 50% last year, to $36 billion, and could more than triple again, to $131 billion, by 2028, according to Durham, North Carolina–based research firm Iqvia Institute for Human Data Science. To run Kailera, the investors hired an all-star: Ron Renaud, a 56-year-old former biotech stock analyst with a nearly unequaled track record of building biotech startups and then selling them for big profits. Over the past decade, Renaud has run and sold three companies—Idenix (focused on hepatitis C), Translate Bio (an mRNA therapeutics company) and Cerevel (centered on neurological diseases)—for a total of $16 billion. 'We have probably the most advanced, diverse, late-stage pipeline that is focused exclusively on weight management, outside of Big Pharma,' he says. By going to China, Kailera skipped years of research and lab work. Renaud now plans to move aggressively with Phase III clinical trials in the U.S. for that first drug in hopes of bringing it to market by 2030 if not sooner. That might sound a long way off, but in the scheme of drug development and approval, it's lightning-fast, thanks to Hengrui's early work. If all goes well, Kailera's first drug should launch ahead of competitors that are now doing early- and mid-stage clinical trials. And the fact that Kailera's licensing deal with Hengrui includes two drugs that can be taken orally is a potentially huge advantage in a market currently dominated by injectable drugs. Pills are such a big deal that Lilly had stockpiled some $550 million worth of its oral GLP-1 weight loss drug orforglipron at year end despite not having FDA approval. Pills, after all, are not only less intimidating for patients but also cost far less to produce and distribute. Some 40% of American adults are obese. That means there is currently a pool of more than 100 million people who could qualify medically for one of Kailera's therapeutics. And that, Renaud says, is before you account for a rising obesity rate, the global market beyond the States or the potential for these drugs to treat related conditions, including cardiovascular disease and even some cancers. 'That is an incredible market opportunity,' he says. 'That's not going to be addressed by a single drug, or two, or three.' Patrick welsh for forbes By John Buckingham Zimmer Biomet, which specializes in orthopedic implants for hips, knees, feet, ankles, shoulders and other surgical implants, has been facing investor concerns about the potential impact of GLP-1 drugs (such as Ozempic), which have the potential to make a dent in global obesity rates. The thought is that lower body mass indexes could result in fewer joint-related surgeries. ZBH CEO Ivan Tornos claims the opposite is true. Lower rates of obesity will actually be a boost for Zimmer considering that damaged cartilage, osteoarthritis and other joint issues are typically irreversible, and thinner people will want to be more mobile. ZBH should be trading for more than its current forward P/E ratio of 14, given healthy bottom-line growth expected for the foreseeable future and a historic average P/E in the mid-20s. John Buckingham is a portfolio manager and editor of The PrudentSpeculator 'I don't know how you make decisions about medicines unless you understand things at the low level, and Ron was that person—he always understood his business down to the low level,' says John Milligan, the former CEO of Gilead Sciences, who is now Kailera's chairman. (The two first met in the early 2000s when Milligan was Gilead's CFO and Renaud was a biotech analyst who refused to put a 'buy' on the then-high-flying stock.) For Kailera, the next step is getting its first drug ready to go through FDA approval while building out research and manufacturing in the U.S. Large-scale clinical trials like those required for weight loss drugs cost a fortune, and Kailera will need to raise funds, almost certainly hundreds of millions, to cover the expense. While Renaud won't talk about what the company might be worth, PitchBook says it was valued at $595 million at its initial funding. Early-stage publicly traded obesity biotechs Metsera and Viking Therapeutics sport market caps in the $3 billion range. In October, Renaud hired Scott Wasserman, who served as Amgen's first cardiologist and built its cardiovascular and metabolic portfolios, as its chief medical officer. Then, in January, he brought on one of the country's top obesity drug marketers as his chief commercial officer: Jamie Coleman. Her prior gig? Repping Zepbound for Lilly. Chairman Milligan figures the obesity field is far larger than those of HIV and hepatitis C when he was leading Gilead, which had a recent market cap of $133 billion. 'We can build a substantial company if we can raise enough capital and fend off acquisitions, which is hard to do in this industry,' he says. If it can't, Kailera may go the way of Renaud's previous efforts and wind up being sold to one of the major pharmaceutical firms, adding a fourth notch to his belt and potentially billions of dollars more in upside.
