Two leading glucagon-like peptide-1 (GLP-1) receptor agonists for obesity and type 2 diabetes – Novo Nordisk A/S’s semaglutide (Wegovy/Ozempic) and Eli Lilly and Co.’s tirzepatide (Mounjaro/Zepbound) – are advancing in China after taking the U.S. market by storm. China represents the world’s largest population of diabetes and obesity patients. Its GLP-1 market, valued at about $1.7 billion in 2023 according to Clarivate, is expected to grow as the number of obesity patients is projected to exceed 500 million by 2033.  

Intercept‘s Ocaliva faces challenging adcom

Friday the 13^th could be a make-or-break day in the U.S. for Intercept Pharmaceuticals Inc.’s Ocaliva (obeticholic acid). That’s the day the company will make its case before the FDA’s Gastrointestinal Drugs Advisory Committee for turning an 8-year-old accelerated approval into traditional approval. To do that, Intercept will have to convince the committee, and the FDA, that the drug’s benefit as a second-line treatment for primary biliary cholangitis outweighs its risks, which have led to a post-approval boxed warning. “There were already known issues regarding the failure of [Intercept’s] Ocaliva post-marketing study,” RBC Capital Markets LLC analyst Brian Abrahams said. But in its briefing document, the FDA “appeared much more concerned about the quality of the confirmatory data and underlying trends,” including a worse-than-placebo trend in the key endpoint of deaths and transplant in the labeled population, Abrahams noted.

Bio Hong Kong 2024: Chapter 18A entices more biotech IPOs

The Stock Exchange of Hong Kong (HKEX) is “all ears” to foster local biotech IPOs, speakers said at the Bio Hong Kong 2024 conference Sept. 11, and more than 60 companies have jumped on board since the introduction of the Chapter 18A listing regime in 2018. Presenting a report on Hong Kong-listed biotech companies, Paloma Wang, a partner at law firm Skadden, Arps, Slate, Meagher & Flom LLP, noted that the new listing track introduced in 2018 was “deliberately crafted” so that pre-revenue companies could list in Hong Kong, helping position HKEX as a gateway to mainland China and the greater global market.

Briacell’s Bria-IMT phase II breast cancer data strengthens

The newest data show increased life for patients in Briacell Therapeutics Corp.’s breast cancer treatment. The company’s phase II results produced positive overall survival (OS) data using the cell-based immunotherapy Bria-IMT to treat late-stage metastatic breast cancer. Bria-IMT, combined with an immune checkpoint inhibitor, produced a median OS of 15.6 months compared to an OS range of 6.7 to 9.3 months for patients in other studies with the same disease. That’s a big jump since Briacell’s December data showed a median OS of 13.4 months. The company’s stock (NASDAQ:BCTX) also took a big jump, sometimes as high as 100% higher, but settling at midday with a 17% increase at 73 cents each.

Chinabio 2024: Global economic uncertainty takes toll on biotechs

From local drug discovery to global innovation, economic uncertainty is taking a toll on China’s innovative biotech system, forcing local companies to weather unpredictable storms, investors said during the Chinabio Partnering Forum in Shanghai Sept. 10-11. The last two years have been particularly challenging in China, with health care investment down 70% and foreign investment down 90%, said CEC Capital Group founding partner Irene Hong. IPOs on the Hong Kong market have been weak and geopolitical issues are getting more challenging, she said. “In finance everyone wants predictability, but we are in the most unpredictable times,” said Victor Tong, managing director of Decheng Capital.

Newco news: Radiant Bio’s $35M series A advances Multabody platform

A drive to overcome the limitations of traditional antibodies led Toronto-based scientists Jean-Philippe Julien and Bebhinn Treanor to work toward discovering a multivalent, multispecific platform to develop therapies that can reach difficult targets. As a result, through the support of VC firm Amplitude Ventures, Radiant Biotherapeutics emerged in 2020 armed with what has become its Multabody platform. The company, which is based in both Toronto and Philadelphia, came out of stealth in April 2023, raising $8 million in seed money and inking two pharmaceutical partnerships. By December, Radiant secured $2 million through an HIV-focused grant from the Bill & Melinda Gates Foundation. Another $35 million in funding, through a series A round disclosed Sept. 11, validates the company’s technology even further, as both Amplitude and the Gates Foundation co-led the financing.

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