Novo Nordisk's Frehemgo wins EMA panel backing for hemophilia A

Boya Bio-pharmaceutical announced on the evening of October 8 that its board of directors received a written resignation report from Chairman Qiu Kai that day. Due to work adjustments, Qiu Kai applied to resign as chairman of the eighth board of directors and as a non-independent director, and also resigned as chairman of the board's Strategy and ESG Committee and as a member of the Nomination, Compensation and Assessment Committee. After his resignation, he will no longer hold any position in the company, and the resignation report took effect on the same day after the conclusion of the board meeting. On the same day, Boya Bio-pharmaceutical held the twenty-third meeting of the eighth board of directors and agreed to nominate Li Ning as a candidate for non-independent director of the eighth board of directors. The announcement shows that Li Ning previously served as deputy general manager of the marketing management center of China Resources Double-Crane Pharmaceutical, head of the market access department of the operating company, general manager of the Beijing business division, and director of the operating company's business division. He currently serves as vice president of China Resources Pharmaceutical Group and chairman of China Resources Biopharmaceutical.

Novo Nordisk announced two European regulatory advances for its Rare Disease portfolio, with the European Medicines Agency's Committee for Medicinal Products for Human Use recommending approval of denecimig, to be marketed as Frehemgo, for hemophilia A in adults and children with or without inhibitors, and issuing a positive opinion for once-weekly Sogroya, or somapacitan, in children with idiopathic short stature or unexplained shortness. Both decisions still require final European Commission action. Novo expects to launch Frehemgo in the first European countries in the fourth quarter of 2026, followed by broader EU availability in early 2027, and denecimig is also under FDA review for the same hemophilia A indication. The Sogroya opinion follows a May 2026 CHMP recommendation for children with short stature born small for gestational age and those with Noonan syndrome, and the pending EC decision will cover all three indications; if approved, Sogroya would become the first and only growth hormone treatment authorized for idiopathic short stature in the EU. Novo generated DKK 9.1 billion in adjusted Rare Disease sales in the first half of 2026, and the segment also includes Alhemo, approved in the United States, Europe, Japan and Australia for routine prophylaxis in patients aged 12 years and older with hemophilia A or B, plus etavopivat, which has completed phase III development in sickle cell disease and phase II development in thalassemia. The Rare Disease push comes as Novo's core GLP-1 franchise faces intensifying competition, with Eli Lilly's Mounjaro generating $18.6 billion in first-half 2026 sales, up 106% year over year, and Zepbound sales rising 60% to $9.1 billion, while Novo's first-half Ozempic sales declined 2% at constant exchange rates and Wegovy product sales increased 7%.