Sitala Bio Ltd.

Shanghai-based Fosun is upping efforts to build out an immunology and inflammation pipeline.\n Fosun Pharma has penned its third inflammatory disease pact in three weeks, plucking up China rights to a clinical-stage treatment from Accro Bioscience.Shanghai-based Fosun is putting down 60 million Chinese Yuan ($8.3 million) upfront and offering 20 million Chinese Yuan ($2.8 million) in near-term milestones contingent on a manufacturing tech transfer, according to an Aug. 29 release.Fosun is further offering Chinese biotech Accro up to 76 million Chinese Yuan ($10.6 million) in development milestone payments, plus potential commercial milestones and royalties.In exchange, Fosun will gain exclusive rights to Accro’s TYK2/JAK1 inhibitor in Greater China, while the biotech will hang on to the asset\'s remaining global rights.The candidate, called AC-201, is an oral small molecule in development for immune-mediated inflammatory diseases.Accro has wrapped up phase 2 testing for AC-201 in moderate-to-severe plaque psoriasis. The trial met its primary endpoint after 12 weeks of treatment, according to the release. The candidate was found to be generally safe and well tolerated, with no serious adverse events reported and no adverse events leading to discontinuation.For Accro, AC-201 is one of three clinical candidates, alongside a RIPK2 inhibitor and a RIPK1 inhibitor that have both gone through phase 1 testing. The biotech is based in Suzhou and focuses on the molecular mechanisms of regulated cell death. As for Fosun, the deal bolsters the pharma’s efforts to build out its immunology and inflammation pipeline. The pharma has made I&I half of its core strategy, with oncology making up the other key focus.Just a few days ago, the company outlicensed an inflammatory disease candidate to a Western biotech, Sitala Bio, for up to $670 million.A couple of weeks earlier, Fosun offered up ex-China rights for an investigational DPP-1 inhibitor to Expedition Therapeutics, a U.S.-based biotech aiming to bring China-developed candidates stateside for global development.

The first overall survival win for a PD-1xVEGF drug, Fosun Pharma's immune disease deal with Sitala Bio and Hutchmed's acting CEO appointment made our news this week. Akeso and Summit Therapeutics' PD-1xVEGF drug has delivered its first overall survival win in a phase 3 trial. Fosun Pharma out-licensed another immune disease candidate. Hutchmed's CEO took medical leave. And more.1. Akeso, Summit's PD-1xVEGF drug meets overall survival goal for the first time in a lung cancer trialFor the first time, Akeso and Summit Therapeutics’ ivonescimab has hit the overall survival goal in a phase 3 trial. The study, HARMONi-A, tested the PD-1xVEGF drug alongside chemo in patients with previously treated EGFR-mutated nonsquamous non-small cell lung cancer in China. The success of the trial increases the chances that its global version, HARMONi, could meet its overall survival goal, too, Evercore ISI analysts said.2. Sitala, backed by Forbion and OrbiMed, seals $670M deal for Fosun immune disease drugFosun Pharma has signed its second immune-related disease deal in about two weeks. For up to $670 million, the Chinese biopharma is granting Britain’s Sitala Bio ex-China rights to its drug coded FXS6837. Existing therapies for the candidate’s targeted indications generated $3.8 billion in global revenue last year, Fosun said, citing IQVIA data.3. Hutchmed names interim chief as CEO Weiguo Su takes medical leaveHutchmed CEO Weiguo Su, Ph.D., is taking a leave of absence due to health reasons, the company said Monday. The firm’s chief financial officer Johnny Cheng has been named acting CEO to oversee day-to-day operations and management of the company. “This has been a very difficult decision to make, but at this time my focus must be on my health,” Su said in a statement.4. Akeso scores twice in pair of phase 3 trials, teeing up regulatory submission in ChinaAkeso is more than just an oncology company. The company just recorded two positive phase 3 readouts for two of its inflammatory disease candidates. The two drugs, the anti-IL-17A agent gumokimab and the anti-IL-4Rα med manfidokimab, were successful in their respective Chinese trials in active ankylosing spondylitis and atopic dermatitis. Akeso is now planning regulatory submissions in China.5. RemeGen and Vor score again with telitacicept, this time in IgA nephropathyRemeGen’s telitacicept has pulled off another China phase 3 win. The IgA nephropathy study met its primary endpoint, linking the BLyS/APRIL dual-target agent to a 55% reduction in 24-hour urine protein-to-creatinine ratio at 39 weeks compared with placebo. RemeGen recently partnered with Vor Bio on the drug outside of China.Other News of Note:6. Nippon Kayaku, Formiica, CBC form Singapore JV to license drugs in Asia (release)7. Nasdaq-listed LakeShore receives buyout offer from investment consortium (release)8. Chinese CRO ChemPartner gets ready to debut new Boston research facility

Plus, news about Nykode, Therna Biosciences, Fosun, Sitala Bio, Catalyst Pharmaceuticals and Lupin: 🔎 Lilly’s Verzenio improves survival in early breast cancer: In the seven-year analysis of the monarchE trial, two years of treatment with Verzenio on top of endocrine therapy as an adjuvant therapy improved survival compared to endocrine therapy alone. The massive study enrolled over 5,000 patients with HR+, HER2-, node-positive early breast cancer at high risk of recurrence. Lilly kept details under wraps, saying the data will be shared at a future medical meeting. Verzenio was first approved in this indication in 2021 with an expanded label in 2023. — Lei Lei Wu 📝 RemeGen gets another Phase 3 win: This time, the Chinese biotech’s drug telitacicept succeeded in an IgA nephropathy trial, and it plans to ask Chinese drug authorities for approval. In the Phase 3 study, telitacicept cut a kidney function measure known as 24-hour UPCR by 55% at 9 months compared to placebo. The news was announced by its Cambridge-based partner Vor Bio, which holds rights to the drug outside China, Hong Kong, Macau and Taiwan. Vor Bio’s shares $VOR fell 3% Wednesday morning. Earlier in August, RemeGen’s drug also passed a Sjögren’s study . If approved, the Sjögren’s indication would mark telitacicept’s fourth indication, while IgA nephropathy would be its fifth in China. — Lei Lei Wu 🔭 Nykode seeks to re-partner cancer vaccine: The Oslo-based biotech said that it’s seeking to attract potential partners for its individualized neoantigen cancer vaccine VB10.NEO, and will make a limited investment in the program moving forward. Genentech dropped its deal with Nykode over the experimental cancer vaccine at the start of this year. — Lei Lei Wu 💰 Therna Biosciences lands $10M: The RNA medicines startup emerged with a seed round from AIX Ventures, Pear VC and Fusion Fund to work on an AI-driven platform. It was founded by UCSF and Arc Institute investigator Hani Goodarzi. San Francisco-based Therna is led by co-founder and CEO Nazli Azimi, who previously founded Bioniz Therapeutics. — Kyle LaHucik 🤝 Fosun does another Western deal: The Shanghai biotech is licensing an inflammatory disease drug candidate to Sitala Bio. The UK biotech is backed by Forbion and OrbiMed, according to the websites of the investors. Fierce Biotech reported on the deal on Tuesday, noting it’s worth up to $670 million. Fosun did a lung disease licensing deal with Expedition Therapeutics earlier this month. — Kyle LaHucik 🖊️ Catalyst Pharmaceuticals settles patent dispute with Lupin: The US biotech has inked an agreement with India’s Lupin over a generic version of Catalyst’s treatment, called Firdapse, for Lambert-Eaton myasthenic syndrome. Under the terms of the settlement, Lupin can’t market its generic drug until Feb. 25, 2035. Catalyst reached a similar agreement with Teva in January. — Ayisha Sharma