DAIICHI SANKYO, INC.

Sarepta Therapeutics, known for its focus on Duchenne muscular dystrophy, made a $500 million upfront deal with Arrowhead Pharmaceuticals, investing $325 million and up to $10 billion in milestones. The deal aims to diversify Sarepta's pipeline with RNA drugs and expand its portfolio into new disease areas. Despite Elevidys failing a confirmatory trial, Sarepta secured full FDA approval and a label expansion, generating $181 million in Q3. The deal reflects Sarepta's ability to secure regulatory success and diversify its portfolio, potentially offering new options for patients with rare diseases.

Esperion Therapeutics filed NDSs in Canada for Nexletol and Nexlizet to reduce LDL-C and cardiovascular risk. Nexlizet combines bempedoic acid and ezetimibe. Shares rose 10.7% post-announcement. The drugs are approved in the U.S. and Europe, marketed as Nilemdo and Nustendi ex-U.S. (excluding Japan). Label expansions in 2024 support broader use, with net product sales up 46.2% YOY in 2024. Otsuka Pharmaceutical filed for bempedoic acid in Japan, potentially boosting future sales.

T.C. has consulted/advised/spoken for ASCO Post, AstraZeneca, Bio Ascend, Bristol Myers Squibb, Clinical Care Options, Daiichi Sankyo, Genentech, IDEOlogy Health, Medical Educator Consortium, Medscape, Merck, OncLive, oNKo-innate, PEAK Medicals, PeerView, Pfizer, Physicians’ Education Resource, RAPT Therapeutics, Regeneron, Targeted Oncology. W.N.W.Jr. has consulted/advised/spoken for Amgen, AstraZeneca, Bayer, BMS, Boehringer Ingelheim, Daiichi-Sankyo, Eli Lilly, Genentech/Roche, Ipsen, Janssen, Merck, MSD, Novartis, Pfizer, Sanofi-Aventis, Takeda, United Medical.

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Daiichi Sankyo plans to build a $152 million facility in Shanghai to produce antibody-drug conjugates for cancer treatments in response to growing Chinese demand.

Kelun-Biotech's sacituzumab tirumotecan (sac-TMT) receives NMPA approval in China for triple-negative breast cancer, competing with Gilead's Trodelvy. The drug, also under review for EGFR-mutant NSCLC, is partnered with MSD, potentially worth up to $1.4 billion. Phase 3 study results showed a 47% reduction in death risk.

Eli Lilly's share price rose 37% due to Zepbound approval, while Pfizer fell 10.77% under activist investor pressure. Merck dropped 7.46% as Keytruda nears patent expiration. Amgen's share price declined 5.92% after MariTide's Phase II results. Vertex's share price increased 13.35% with CF drug success. Novo Nordisk's share price rose 2.76% with Wegovy's market impact.

The global antibody drug conjugate market is projected to grow from USD 7.72 billion to USD 23.3 billion by 2035, driven by advancements in antibody engineering and clinical trial successes. Over 280 ADCs are approved or in clinical studies, with 250+ in early development. Key segments include breast cancer, solid tumors, and HER-2 antigen. North America leads in market share, while Asia-Pacific shows higher growth potential.

Asia-Pacific leads in vaccine development with 46% of global prophylactic trials and 31% of therapeutic trials, driven by technological innovations, strategic investments, and regional collaborations. The industry shifts from prophylactic to therapeutic applications, with mRNA and viral vector platforms, genomics, AI, and therapeutic innovations in oncology shaping the future. Challenges include vaccine equity, regulatory complexities, and public hesitancy, but strategic investments and collaborations are reshaping the sector.

FDA approved zolbetuximab-clzb (Vylov) plus chemotherapy for HER2-negative, CLDN18.2-positive gastric/GEJ adenocarcinoma, addressing unmet need in PD-L1–low/HER2-negative patients. Routine CLDN18.2 testing is crucial for targeted therapy in previously non-targetable populations.