Investors pressured Takeda CEO on potential competition to Shire's blood disease products. The FDA has approved Biocon's Bangalore plant, where it makes biosimilars under partnerships with Mylan and Novartis. China's C-Bridge Capital has invested $35 million in Nuance Biotech to support future in-licensing deals. And more.
During a recent investor meeting, Takeda CEO Christophe Weber was pressed on how sustainable sales from Shire’s hemophilia unit will be in the face of competition like Roche’s Hemlibra, the Financial Times reported. The drugs are key to Takeda's $62 billion buyout of Shire. Roche is currently seeking to expand Hemlibra’s application in patients without factor VIII inhibitors and has priced the drug at a significant discount to Shire’s Adynovate.
Biocon’s Bangalore plant, where it makes biosimilars, has received an EIR, clearing the plant in a recent FDA inspection. The agency previously issued the plant a 10-observation Form 483 which led to a postponed consideration of a Mylan-partnered biosimilar of Roche’s Herceptin. Its problems also led to the rejection of a Neulasta biosimilar.
Chinese private equity C-Bridge Capital has led a $20 million series B round into Shanghai-based Nuance Biotech, with an additional $15 million earmarked for acquisition of new products. Nuance recently licensed Chinese rights to Pacira Pharmaceuticals’ nonopioid agent Exparel, and has several products already on the market or in registration with the Chinese authority.
Chinese immune-oncology company Adlai Nortye Biopharma raised $50 million in a series B led by Yuanming Capital. Founded in 2004, the company has in-licensed Oncolytics’ Reolysin and Eisai’s EP4 antagonist E7046. Reolysin, the farthest in Adlai’s pipeline, is entering phase 3 in breast cancer, while E7046 has the potential to become first-in-class.
Henan Lihua Pharmaceutical, which specializes in production of corticosteroids APIs, was hit with an FDA warning letter. Previous inspections of the company’s two plants found its quality control unit wasn’t approving the release of the company’s products.