Bharat Biotech International Ltd.

New Delhi: India's cell and gene therapy pioneer ImmunoAct has turned profitable in its first full year of operations, a rare feat in the country's emerging startup landscape where research-based pharma enterprises encounter serious scale and cash flow challenges. ImmunoACT, in which Hyderabad-based drugmaker Laurus Labs has roughly 34% equity stake, saw revenues of ₹62 crore with a profit before tax of ₹12 crore in FY25, according to sources. The year before, ImmunoAct had revenues of ₹11 crore. Founded by immunologist Rahul Purwar in 2013, ImmunoACT was spun off from the department of bioengineering department of IIT Bombay in 2018. ImmunoACT's NexCAR19 is the first indigenously developed breakthrough cancer CAR-T (chimeric antigen receptor T-cell) therapy approved by India's central drug regulatory agency in October 2023. NexCAR19 was formally launched in India in April 2024 at a price ~90% cheaper than its US and European counterparts like Novartis and Gilead, making it far more affordable for India and low-and-middle income countries, on its potential approval. So far, the therapy has been infused in over 350 patients across 70 hospitals in India. In CAR-T treatment, the patient's immune cells are extracted and through a maze of re-engineering processes infused back to recognize and kill cancer cells, giving a longer remission to patients as compared to the conventional options like immunotherapy or bone marrow transplants. The therapy is used when all other options are exhausted. Each CAR-T dose (one-and-done infusion) costs around ₹30 lakh, which was initially priced at ₹42 lakh, and is expected to see a further decline as demand picks up. Meanwhile, ImmunoACT has recently appointed former managing director of Roche India V Simpson Immanuel as its strategic advisor. Rahul Purwar added, "We needed someone who understands not just the commercial landscape, but also the nuances of innovation, patient access, and global expansion." Earlier this year, Immuneel Therapeutics, backed by leading names like Kiran Mazumdar-Shaw and globally renowned oncologist Siddhartha Mukherjee secured approval for Qartemi, its cell therapy for adult B-cell non-Hodgkin Lymphoma, in India. Companies like Cipla , Dr Reddy's Labs and Bharat Biotech are investing heavily in new CAR-Ts. Globally, CAR-Ts are at the frontiers of a range of cancer treatments, attracting billions of dollars in investments from large drugmakers. The market for such therapies is expected to touch $134 billion by 2034 from around $10 billion at present. By Vikas Dandekar ,

Vor Bio and RemeGen's market-dividing licensing deal, Otsuka and Harbour BioMed's BCMA T-cell engager pact, and Datroway's second FDA nod made our news this week. A potential $4 billion licensing deal with Vor Bio triggered a slide in RemeGen's stock price. Otsuka obtained a BCMAXCD3 bispecific from Harbour BioMed to develop against autoimmune diseases. AstraZeneca and Daiichi Sankyo's Datroway secured a lung cancer approval from the FDA. And more.1. Vor Bio's surprise $4B revival deal for RemeGen's autoimmune drug triggers divergent stock reactionsOn the brink of shutting down, Vor Bio has been revived by a licensing deal with China’s RemeGen. For $45 million upfront and up to $4.1 billion in milestones, the Massachusetts biotech is gaining ex-China rights to RemeGen’s BLyS/APRIL dual-target fusion protein telitacicept, which is approved in China to treat several autoimmune diseases. However, RemeGen’s stock price dropped sharply after the news.2. Otsuka pens $670M pact to point Harbour's preclinical T-cell engager toward autoimmune diseaseIn another autoimmune-focused deal involving a Chinese biotech, Otsuka agreed to pay Harbour BioMed $47 million upfront for ex-China rights to a preclinical BCMAxCD3 bispecific candidate. While Harbour got the Chinese green light to test the asset in cancer patients, Otsuka plans to test the drug, HBM7020, against autoimmune conditions.3. AZ, Daiichi's Datroway scores its 2nd FDA approval—this time in lung cancer subsetAstraZeneca and Daiichi Sankyo’s TROP2-targeted antibody-drug conjugate Datroway has picked up its second FDA nod after a refile. Datroway secured the EGFR-mutated non-small cell lung cancer indication after the companies had withdrawn an earlier application in nonsquamous NSCLC following a phase 3 overall survival miss.4. Corxel, Sciwind post GLP-1 data as China's obesity push gathers paceGLP-1 assets from China are showing their power at the American Diabetes Association Scientific Sessions. Sciwind’s phase 3 data linked its injectable GLP-1 receptor agonist ecnoglutide to a mean weight loss of 15.4% after 48 weeks. Phase 2 data on Corxel and Vincentage’s small-molecule GLP-1 candidate showed a 9.7% weight reduction in 16 weeks when given at a fast titration to the highest dose.5. BrightGene tops Novo drug in diabetes ahead of Zepbound showdownAlso at ADA, China’s BrightGene reported that its GLP-1/GIP receptor agonist BGM0504 topped Novo Nordisk’s Ozempic in Chinese patients with Type 2 diabetes in a midstage trial. The drug saw dose-dependent reductions in HbA1c of up to 2.48% after 12 weeks, versus 1.43% for Ozempic and 0.28% for placebo. The biotech also shared phase 2 obesity data comparing BGM0504 against placebo, and the company is pitting the drug against Eli Lilly’s Zepbound in another phase 2 study.6. FDA moves to block Olympus endoscope imports over manufacturing issuesThe FDA warned healthcare providers that it’s shutting down imports of 58 models of aparoscopes, bronchoscopes, nasopharyngoscopes and ureteroscopes, as well as automated cleaners and reprocessing accessories, made by Olympus. The agency cited concerns around quality requirements at a production site in Japan.Other News of Note:7. GSK, Bharat Biotech to slash the price of first malaria vaccine to less than $5 per dose by 20288. Hummingbird uses VISTA buzz to secure $290M pact for phase 2-ready tumor drug9. Arbutus regains China rights to potential functional hep B cure as part of strategic rethink10. Korea’s Abion Bio inks $1.3B deal over CLDN3, other cancer targets (Korea Biomedical Review)

Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Bharat Biotech and GSK said they will reduce the price of their malaria vaccine for children where the disease is endemic. They will do so “progressively” to less than $5 by 2028, which is a price drop of more than half, the companies said Wednesday. The price cut is due to “process improvements, expanded production capacity, cost-effective manufacturing, and minimal profit margins.” The vaccine, codenamed RTS.S, was developed by GSK, PATH and their partners. Emergent BioSolutions’ partnership with the Administration for Strategic Preparedness and Response had a “ contract modification ” worth $62.4 million for its botulism antitoxin. The deal update was made on an existing 10-year contract stating Emergent would supply the antitoxin for stockpiling purposes. Drug supplier Sterling Distributors was handed an FDA Warning Letter after the company was found to be purchasing and distributing prescription drugs across different states, including Florida, Arkansas and Mississippi, without a license. The letter, published Tuesday, states Sterling shipped illegitimate products to customers and failed to investigate any deficiencies even after patient complaints. Six major issues were found in total and the FDA has given Sterling 15 working days to respond. AGC Biologics will start offering its cell therapy services from a site in Yokohama Technical Center in Japan starting next month, the company said Wednesday. This means the company would have cell therapy manufacturing presence in three places, including Milan and Colorado. Catalent now has the upstream phase for the production of GenSight Biologics gene therapy lenadogene nolparvovec, which it calls Lumevoq. The batches will be used for an early access program and a dose-ranging study in France, the pharma company said Thursday. The asset is under investigation for Leber hereditary optic neuropathy. Adial Pharmaceuticals said it tapped Thermo Fisher Scientific and Cambrex to make its alcohol use disorder drug, codenamed AD04, according to a Wednesday release. Ionetix and AlfaRim will be working together to market actinium-225, the companies said last Friday. Additional reporting by Anna Brown.