Biocytogen Pharmaceuticals (Beijing) Co. Ltd. and Nanjing Chia Tai Tianqing Pharmaceutical Co. Ltd. have announced IND clearance by China’s National Medical Products Administration (NMPA) for NTB-003 (formerly BCG-009) for thyroid eye disease.
Mabwell (Shanghai) Bioscience Co. Ltd. on May 30 gained Chinese approval of Mailisheng (albipagrastim alfa; 8MW-0511) as a subcutaneous injection to treat febrile neutropenia induced by myelosuppressive anticancer treatment, such as radiotherapy and chemotherapy.
Mabwell (Shanghai) Bioscience Co. Ltd. on May 30 gained Chinese approval of Mailisheng (albipagrastim alfa; 8MW-0511) as a subcutaneous injection to treat febrile neutropenia induced by myelosuppressive anticancer treatment, such as radiotherapy and chemotherapy.
Kexing Biopharm Co. Ltd. has announced IND clearances this month by China’s National Medical Products Administration (NMPA) and the U.S. FDA for GB-18, a biologic product for the treatment of cancer cachexia.
Hengrui Pharmaceuticals Co. Ltd. announced a global offering on the Hong Kong Stock Exchange to raise up to $1.27 billion to advance its growing pipeline focused on oncology, metabolic and cardiovascular diseases, immunological and respiratory diseases, and neuroscience.
Pfizer Inc. is paying $1.25 billion up front and up to $4.8 billion in milestone payments to gain global, ex-China rights to SSGJ-707, a PD-1/VEGF bispecific antibody from 3Sbio Inc. that recently won China clearance for a phase III study in lung cancer as a potential first-line monotherapy. Announced after U.S. market hours May 19, the exclusive agreement for SSGJ-707 spells up to $6.15 billion combined for Shenyang, China-based 3Sbio, along with separate tiered double-digit royalty payments on sales of SSGJ-707, if approved.
Suzhou Sanegene Bio Inc. has gained clinical trial approval in China for SGB-3383 for the treatment of complement-mediated kidney diseases, including IgA nephropathy, C3 glomerulopathy, immune complex-mediated membranoproliferative glomerulonephritis and atypical hemolytic uremic syndrome.
Hengrui Pharmaceuticals Co. Ltd. announced a global offering on the Hong Kong Stock Exchange to raise up to $1.27 billion to advance its growing pipeline focused on oncology, metabolic and cardiovascular diseases, immunological and respiratory diseases, and neuroscience.
Sirius Therapeutics Inc. raised nearly $50 million in a series B2 financing round May 9 to support its pipeline of small interfering RNA (siRNA) molecules for cardiovascular disease indications. SRSD-107, a long-acting Factor XI anticoagulant for thromboembolic disorders, is its lead candidate waiting on EMA clearance to begin a phase II study in Europe.
China’s National Medical Products Administration has approved Remegen Co. Ltd.’s antibody-drug conjugate (ADC), disitamab vedotin (RC-48), for treatment of HER2-positive advanced breast cancer in patients with liver metastasis.
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