Clover Corp. Ltd.

Novo Nordisk's China obesity deal, Merck's cardiovascular licensing deal, and an FDA rejection for Hengrui and Elevar's PD-1 combo made our news this week. Novo Nordisk snapped up an obesity asset from China's United Laboratories in a deal worth up to $2 billion. Merck & Co. got a lipoprotein(a) inhibitor from Jiangsu Hengrui Pharma for cardiovascular disease. Hengrui and Elevar Therapeutics' PD-1 liver cancer combination was again tripped up by manufacturing at the FDA.1. Novo Nordisk pens $2B deal for triple G agonist tied to 15% weight loss at 12 weeksNovo Nordisk has bought into the “triple G” idea, gaining a GLP-1/GIP/glucagon triple agonist from China’s United Laboratories for up to $2 billion. The candidate, coded UBT251, would be a direct competitor to Eli Lilly’s retatrutide. In a phase 1b trial, weekly UBT251 at the highest subcutaneous dose of 6 mg led to an average 15.1% weight loss from baseline after 12 weeks.2. Merck & Co. pens $200M upfront deal for Hengrui's midstage heart disease medIn another China deal potentially worth up to $2 billion, Merck & Co. is paying $200 million upfront for a phase 2 lipoprotein(a) inhibitor from Hengrui Pharma. Elevated Lp(a) in the blood, as a risk factor for cardiovascular disease, has become an increasingly popular target. Lilly has a clinical candidate called muvalaplin, and AstraZeneca last year licensed a preclinical one from China’s CSPC Pharma.3. FDA rejects Hengrui, Elevar's PD-1 cancer drug combination—againIn a piece of bad news for Hengrui, the FDA has once again rejected its Elevar Therapeutics-partnered combination of the PD-1 inhibitor camrelizumab and VEGFR inhibitor rivoceranib. Like the first rejection last year, the FDA this time also raised problems with Hengrui’s camrelizumab manufacturing facility in China.4. AbbVie takes Genmab to court, accusing partner of being 'willfully blind' to ADC trade secret theftAbbVie has sued Genmab over the Danish company’s $1.8 billion acquisition of Sino-American biotech ProfoundBio last year. The Illinois pharma alleged that Genmab was “intentionally and willfully blind” to Profound’s alleged theft of its antibody-drug conjugate trade secrets. Genmab said it “categorically refutes allegations and will vigorously defend the company.”5. J&J combo signals new era in EGFR lung cancer with survival win against AstraZeneca's TagrissoJohnson & Johnson’s Rybrevant and its Yuhan-partnered Lazcluze significantly reduced the risk of death by 25% versus AstraZeneca’s Tagrisso in first-line EGFR-mutated non-small cell lung cancer, according to a high-stakes readout from the phase 3 Mariposa trial. J&J believes the overall survival win sets the combo up to be the new standard of care. But the high-maintenance nature of the regimen poses a challenge.6. Drugmakers fear Trump tariffs will drive up manufacturing costs, hurt medicine access: BIO surveyTrump again threatens tariffs on pharmaceuticals in 'not too distant' futurePresident Donald Trump said his administration will announce tariffs on pharmaceuticals “in the not too distant” future. But in a recent survey conducted by the Biotechnology Innovation Organization, a large proportion of biopharma companies polled said tariffs on EU, Canada or China will drive up manufacturing costs. Many respondents also fear that tariffs could disrupt R&D and regulatory plans.7. FDA calls out 'particularly concerning' claims on HCP site for Taiho's LytgobiThe FDA has taken issue with Taiho Oncology’s doctor-facing web page for the cholangiocarcinoma drug Lytgobi. The agency raised concerns that some descriptions of the drug’s overall survival and progression-free survival data from a single-arm phase 2 study were misleading. The agency is giving the firm 15 working days to submit a written response.8. Eisai lays out road map to blockbuster sales projections for Leqembi's 'milestone' 2027 year9. Contractors WuXi Bio, WuXi XDC eye continued growth after logging solid performances in 202410. Gavi terminates COVID vaccine deal with Clover, demands $224M repayment11. Ascletis slashes funding for former core programs in pivot to obesity12. ImmuneOnco axes CD47 bispecific as pipeline prioritization pressures hit Chinese biotech13. India's Aspen Biopharma Labs hit with FDA warning letter citing infrastructure, contamination and records problems14. Biotech designed to commercialize Ascendis' endocrinology drugs in China files $86M IPO15. Bharat Biotech enters cell and gene therapy market with $75M production investment: reports16. Bayer gains Puhe’s cancer drug candidate in another China deal (release)17. Kaken agrees to $180M deal to develop Alumis' lead TYK2 inhibitor in Japan

International vaccine organization Gavi has discontinued a COVID vaccine partnership with China's Clover Biopharmaceuticals and is asking for repayment of $224 million. Last year, Novavax reached a settlement with Gavi, the Vaccine Alliance, after the international partnership demanded repayment following the termination of an advance purchase agreement for COVID-19 vaccines.Thirteen months later, Gavi may be on its way to a similar skirmish with China’s Clover Biopharmaceuticals after discontinuing another purchase agreement surrounding COVID shots.In a regulatory filing, the Shanghai-based company said that Gavi has sent notice of the termination of their vaccine deal and is demanding that the company return an advance payment of $224 million. “The Company rejects such claim for a repayment, believing it is without merit based on the terms of the Advance Purchase Agreement, and will defend itself vigorously,” Clover wrote, adding that it was not aware of any associated legal claims.Gavi did not respond immediately to a request for comment. In June of 2021, Clover and Gavi signed on to their partnership, with the company agreeing to provide up to 414 million doses of SCB-2019, its protein-based COVID shot, through 2022. But like Novavax, Clover struggled to meet regulatory targets in developing its vaccine.If Gavi succeeds in its latest demand, Clover may not have enough cash to pay the organization back. The biotech is struggling financially. In its most recent earnings release, after the first half of 2024, the company reported negative revenue. Its cash and cash equivalents had shrunk from 1.8 billion Chinese yuan ($248 million) at the end of 2022 to 830 million Chinese yuan ($114 million).  With the COVID shot now a dud, Clover is banking its future on a respiratory syncytial virus (RSV) vaccine candidate coded SCB-1019. The company also revealed on Monday that the FDA has cleared its application to start an in-human clinical trial of the non-adjuvanted bivalent RSV vaccine.The company added that it has enrolled the first participants in a phase 1 revaccination trial of the prefusion-stabilized F (PreF)-Trimer subunit shot. Results from another phase 1 trial last year indicated that SCB-1019 is a potential best-in-class vaccine compared to GSK’s Arexvy, Clover said.

— U.S. IND clearance and revaccination trial initiation supports the differentiated global opportunity for Clover’s RSV PreF vaccine (SCB-1019) utilizing validated Trimer-Tag platform — — Evaluation of SCB-1019 as part of a respiratory combination Trimer-Tagged PreF vaccine (RSV + hMPV ± PIV3) is also on track for clinical trial initiation in 2025 — SHANGHAI, China I March 23, 2025 I Clover Biopharmaceuticals, Ltd. (Clover; HKEX: 02197), a global commercial-stage biotechnology company committed to unleashing the power of innovative vaccines to save lives and improve health around the world, today announced IND clearance by U.S. FDA and that enrollment of the first participants has been completed in a Phase I revaccination clinical trial evaluating SCB-1019 – the company’s non-adjuvanted bivalent RSV prefusion-stabilized F (PreF)-Trimer subunit vaccine candidate based on Clover’s Trimer-Tag vaccine technology platform. “We are pleased to announce the U.S. IND clearance and revaccination clinical trial initiation, which supports the differentiated global opportunity of Clover’s RSV PreF vaccine (SCB-1019) utilizing our validated Trimer-Tag platform,” said Joshua Liang, Chief Executive Officer & Board Director of Clover. “While currently approved protein-based RSV vaccines are safe & effective when given as an initial dose, critical gaps persist globally: (1) suboptimal boostability for revaccination when protection against RSV disease wanes, and (2) inability to prevent respiratory disease caused by other viruses related to RSV such as hMPV and PIV3. Thus, we look forward to the clinical trial results for SCB-1019 in an RSV re-vaccination setting and as part of a respiratory combination vaccine (RSV + hMPV ± PIV3).” In October 2024, Clover announced Phase I results in 70 older adults (60-85 years) who were RSV vaccine-naïve, and results indicated a potential best-in-class combined immunogenicity & tolerability profile of non-adjuvanted SCB-1019 compared head-to-head to GSK’s AS01 E -adjuvanted RSV vaccine (AREXVY). The ongoing Phase I revaccination trial in the U.S. is enrolling up to 160 older adults (60-85 years) who previously received an initial dose of GSK’s RSV vaccine (AREXVY) at least 2 seasons prior, and participants will be randomized to receive either a heterologous revaccination dose of SCB-1019, a homologous AREXVY revaccination dose or saline placebo. The study will assess safety, reactogenicity and immunogenicity. Furthermore, evaluation of SCB-1019 as part of a respiratory combination Trimer-Tagged PreF vaccine (RSV + hMPV ± PIV3) is also on track for Phase I clinical trial initiation in 2025. About Clover Clover Biopharmaceuticals is a global commercial-stage biotechnology company committed to unleashing the power of innovative vaccines to save lives and improve health around the world. With integrated research and development, manufacturing and commercial capabilities as well as strong partnerships with organizations globally, Clover has a diverse pipeline of candidates that have the potential to meaningfully reduce the burden of vaccine-preventable diseases—and to make more diseases preventable. SOURCE: Clover Biopharma