| |NOVEMBER 20258MERCK, BLACKSTONE PARTNER ON $700M CANCER DRUG DEVELOPMENTZYDUS LIFESCIENCES ACHIEVES USFDA COMPLIANCE MILESTONEZydus Lifesciences has been able to accomplish a pre-Approval Inspection PAI successfully without any observation by the US Food and Drug Administration (USFDA) at its SEZ II manufacturing facility in Ahmedabad.The inspection was carried out as part of the regulatory process to ensure that the requirements of quality and good manufacturing practices (GMP) were met.The facility was inspected with no deficiencies found and the Establishment Inspection Report (EIR) has been classified as No Action Indicated (NAI) for the entity. The result is a testimony to the company's excellent compliance model, stringent quality control measures, and overall service to international manufacturing norms.The SEZ II plant is producing essential pharmaceutical formulations for regulated markets, and the USFDA's clean report is a confirmation of Zydus Lifesciences' pledge to conform to global regulatory standards. Besides validating the Ahmedabad facility's operational integrity and quality assurance systems, the PAI clearance also acts as a catalyst for the company's capability to fulfill strict international regulatory requirements.With the clean EIR in hand, Zydus Lifesciences is in a stronger position to be a dependable pharmaceutical manufacturer worldwide and therefore may continue its expansion in regulated markets.This achievement is one among many, wherein the company shows its unwavering commitment to patient welfare by producing high-quality meds that are safe and effective, and at the same time, complying with standard regulations and manufacturing practices.The successful USFDA inspection at SEZ II is the next achievement in Zydus Lifesciences' journey to grow its presence worldwide and maintain its position as a leader in the pharmaceutical industry. POTOP STORIESMerck has entered into a financial agreement with Blackstone Life Sciences (BX.N), which will provide $700 million for the development of an experimental cancer treatment.According to the agreement's stipulations, Blackstone's drug development division will cover part of the expenses associated with testing sac-TMT, an innovative antibody-drug conjugate. Antibody-drug conjugates are engineered to deliver anti-cancer medications more accurately to cancerous cells, resulting in reduced harm to healthy cells compared to traditional chemotherapy.Currently, Merck is assessing sac-TMT in 15 advanced global trials across six different tumor types, including breast, endometrial, and lung cancers. The company is also focused on expanding its drug pipeline as its leading cancer medication, Keytruda, is expected to face competition from more affordable biosimilars in the coming years."We are making important investments .to sustain our business for the future, while remaining disciplined towards maintaining an appropriate financial profile," said Caroline Litchfield, chief financial officer, Merck.The companies announced that the payment is anticipated to be completed throughout 2026. Blackstone is qualified to obtain low-to-mid single-digit royalties based on net sales of sac-TMT, which is dependent on the approval from regulatory authorities in the U.S., sac-TMT is designed to target a protein known as trophoblast cell-surface antigen 2, which is present on the surface of various cancer cells. According to Merck, antibody-drug conjugates that focus on this protein have demonstrated promising anti-tumor efficacy in clinical trials.Furthermore, the company stated that it will maintain oversight of the development, manufacturing, and commercialization processes for sac-TMT, and Blackstone will not be granted any rights to this cancer therapy. Sac-TMT is being developed under an exclusive licensing and collaboration agreement with Sichuan Kelun-Biotech Biopharmaceutical. PO
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