Pembrolizumab

Enhertu's first-line breast cancer approval, unexpected death cases in a Daiichi Sankyo antibody-drug conjugate trial and positive readouts from Takeda's Sotyktu challenger made our news this week. In the last Fierce Pharma Asia weekly news roundup of 2025, Daiichi Sankyo scored a key FDA approval for AstraZeneca-partnered Enhertu in first-line HER2-positive breast cancer but paused a phase 3 trial of its Merck & Co.-partnered antibody-drug conjugate due to unexpected patient deaths. Takeda plans to file its TYK2 inhibitor for an FDA approval following a pair of positive phase 3 trials in psoriasis. And more.1. AZ, Daiichi score with FDA nod for Enhertu combo in 1st-line breast cancerThe FDA has approved AstraZeneca and Daiichi Sankyo’s Enhertu in combination with Roche’s Perjeta as the first new first-line treatment of HER2-positive metastatic breast cancer in more than a decade. In the Destiny-Breast09 trial, the combo significantly lowered the risk of progression or death by 44% compared with the traditional THP regimen.2. Patient deaths prompt partial hold for Daiichi-Merck’s global phase 3 ADC programDaiichi has paused enrollment in a phase 3 trial of its Merck & Co.-partnered B7-H3 antibody-drug conjugate, ifinatamab deruxtecan, after an unexpected number of deaths from interstitial lung disease. The partial clinical hold comes as the pharma partners said they were aiming for an accelerated approval for the candidate for pretreated small cell lung cancer based on a phase 2 readout.3. Takeda looks to 2026 FDA filing for its Sotyktu rival zasocitinib after phase 3 successTakeda said its oral TYK2 inhibitor zasocitinib, a potential competitor to Bristol Myers Squibb’s Sotyktu, succeeded in two phase 3 trials in moderate to severe plaque psoriasis. The drug beat placebo on the trials’ co-primary endpoints of static Physician Global Assessment 0/1 and the Psoriasis Area and Severity Index 75 at Week 16. The company plans to file for an FDA approval. 4. Biosecure Act heads to Trump's desk with defense spending bill after Senate voteBoth the House of Representatives and the Senate have passed the annual defense bill that includes the revamped Biosecure Act. President Donald Trump is expected to sign the massive defense package into law. Once enacted, the updated Biosecure Act will raise hurdles for life sciences companies from China.5. Fosun signs up to take on China's Green Valley, revive controversial Alzheimer's medFosun Pharma is spending about $200 million to take a 53% stake in Green Valley Pharmaceuticals, aiming to revive the latter’s controversial Alzheimer’s disease med, sodium oligomannate (GV-971), after Chinese regulators opted not to renew the drug’s conditional approval. The Shanghai Stock Exchange sent Fosun a regulatory letter related to the proposed transaction. Such a letter typically reminds a public company of potential regulatory breaches.6. Harbour BioMed docks with BMS in antibody discovery, development deal worth up to $1.1BBristol Myers Squibb signed on China’s Harbour BioMed to discover multispecific antibodies. Harbour could receive payments totaling $90 million plus development and commercial milestones of up to $1.035 billion. Before BMS, Harbour had forged collaborations with Otsuka and AstraZeneca earlier this year.7. Sanofi signs $1B biobucks pact for Alzheimer's asset in 2nd biotech deal of the daySanofi has signed a licensing deal worth up to $1.04 billion with South Korean biotech Adel. The pact focuses on ADEL-Y01, a tau-targeting antibody for Alzheimer’s disease. Sanofi will pay $80 million upfront for the clinical-stage asset and related backup compounds. Rather than broadly targeting tau, the drug focuses on tau acetylated at lysine-280.Other News of Note: 8. AI drug designer Insilico Medicine aims to generate nearly $300M in Hong Kong IPO9. Keytruda, Padcev keep winning streak with another patient survival benefit in bladder cancer10. Yarrow blooms with $1.37B deal, landing autoimmune thyroid disease drug from China's GenSci11. Yarrow to go public in reverse merger with Vyne (release)12. Boehringer inks AI protein design pact with Korea’s Galux (release)13. Hansoh sells regional rights to EGFR inhibitor to Glenmark in potential $1B deal (release)14. Lilly to help Korea’s Medi&Gene advance an obesity asset (release) 

New Delhi: Zydus Lifesciences on Tuesday said its UAE-based unit has inked a licensing pact with Formycon AG for the supply of a cancer treatment biosimilar in the US and Canada. Zydus Lifesciences Global FZE has entered into a strategic partnership for the exclusive licensing and supply of checkpoint inhibitor FYB206, a biosimilar of Keytruda (Pembrolizumab). Under the terms of this agreement, Formycon AG will develop, register, manufacture and supply the product, while Zydus Lifesciences Global FZE will be responsible for the commercialisation of FYB206 in the defined territories, the Ahmedabad-based drug maker said in a statement. "This venture marks Zydus' entry into the North American biosimilar market , debuting with an immunotherapy product. This collaboration also complements Zydus' recent proposed acquisition of Agenus Inc.'s California, USA-based manufacturing facilities, which we plan to integrate and leverage for manufacturing in the future," Zydus Lifesciences Managing Director Sharvil P Patel said. By combining expertise and resources, the companies aim to drive significant organisational growth and deliver maximum value to patients through expanded access to affordable oncology care, he added. Shares of Zydus ended 0.48 per cent down at Rs 919.90 apiece on the BSE.