Bharat Biotech International 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

Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Chiesi is investing €430 million ($358 million) over the next five years to refurbish an old building in Milan, Italy, to become a factory for making sterile inhalers and other biologics, according to a Wednesday press release. Vaccine manufacturer Bharat Biotech is building a 50,000-square-foot cell and gene therapy site in Genome Valley in Hyderabad, India. The facility will be the country’s first “integrated” CGT site, the company said on Mar. 20. Aspen Biopharma Labs was placed on import alert on Jan. 15 after an inspection of its site in Telangana, India, resulted in an FDA warning letter published Tuesday. The inspection uncovered four issues, including that the factory was in a state of disrepair. Currax Pharmaceuticals has obtained FDA approval for a second manufacturing site for its obesity drug Contrave to meet demand for weight loss drugs, the company said March 20. Redwire Corporation has secured a contract with NASA to use its tech to aid drug development on the International Space Station, according to a Tuesday press release. The tech, dubbed the “Pharmaceutical In-space Laboratory,” will be used in four studies investigating the manufacture of crystals for pharmaceutical production. Emzor Pharmaceutical is planning to finish the construction of its $230 million active pharmaceutical ingredient plant by the fourth quarter of this year, according to reports. Operations are to begin by the end of the year. The factory was originally slated to be completed in the first quarter of 2024.

Bharat currently has five products in its personalized medicine pipeline—two in cell culture and three in the gene therapy segment, the Hindu Business Line reported late last week. With a storied history in vaccine development, India's Bharat Biotech is shaking things up and answering the call of advanced therapeutics. Bharat has unveiled plans to set up its first cell and gene therapy manufacturing facility at the Hyderabad, India, life sciences cluster known as Genome Valley. The drugmaker will lay out around $75 million for the project, multiple local news outlets have reported. The move by Bharat represents (PDF) its foray from vaccines into cutting-edge regenerative and personalized therapies, the company said in a Mar. 20 press release. Although a specific date wasn’t disclosed, the 50,000-square-foot plant is expected to begin full operations with the finalization of regulatory approvals and the completion of a build-out phase.Bharat currently has five products in its personalized medicine pipeline—two in cell culture and three in the gene therapy segment, the Hindu Business Line reported late last week, citing comments from Bharat's executive chairman Krishan Ella. The company is working on a range of CAR-T cell, CAR-NK cell and off-the-shelf gene therapies, Bharat's chief development officer Raches Ella added, as quoted by the Times of India. “Bharat Biotech, with its extensive experience and proven excellence in viral vaccine manufacturing, is uniquely positioned to master these complexities and produce human-grade vectors at the scale and consistency needed for clinical trials,” Krishan Ella said in the company's release. Additionally, Bharat has revealed a new collaboration pact with the University of Wisconsin-Madison that has the potential to expand into commercial deals that include in-licensing. The company is also looking ahead to exporting and the potential of medical tourism in the cell and gene therapy segment.Bharat popped up on the global radar in 2019 when it became the largest supplier of rabies vaccines in the world after acquiring Chiron Behring Vaccines from GSK in an all-cash deal. The price of the purchase wasn’t disclosed.At the time, India-based Chiron Behring had just a single product in the rabies vaccine Rabipur, while Bharat Biotech was selling a Vero cell-based rabies vaccine, Indirab. The acquisition boosted Bharat's annual rabies capacity to 25 million doses.During the pandemic, Bharat also rolled out a COVID-19 vaccine, dubbed Covaxin, which won approvals in multiple countries including India, Malaysia and Mexico. Attempts to introduce the shot in the U.S. with partner Ocugen proved less fruitful, however. Bharat currently boasts a portfolio of more than 19 vaccines and 4 biotherapeutics, with shots in influenza H1N1, rotavirus, Japanese encephalitis, rabies and cholera, among multiple others.