Greater China News
FDA Grants Traditional Approval for LEQEMBI® (lecanemab-irmb) for the Treatment of Alzheimer’s Disease
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) supporting the traditional approval of LEQEMBI® (lecanemab-irmb) 100 mg/mL injection for intravenous use, making LEQEMBI the first and only approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline in adults with Alzheimer's disease (AD).
Innovent and IASO Bio Announce the NMPA Approval of FUCASO®, the First Fully-human BCMA CAR-T Therapy, for the Treatment of Relapsed or Refractory Multiple Myeloma
Innovent Biologics and IASO Biotechnology announce that China's National Medical Products Administration (NMPA) has approved the New Drug Application (NDA) for FUCASO® (Equecabtagene Autoleucel, co-developed and co-commercialized by Innovent and IASO Bio.
Pharming CEO Sijmen de Vries wins Chief Executive of the Year Award
Pharming CEO Sijmen de Vries wins Chief Executive of the Year Award
I-Mab Announces Publication of Claudin18.2 x 4-1BB Bispecific Antibody Givastomig in JITC
I-Mab (Nasdaq: IMAB) announced the publication of a manuscript entitled "CLDN18.2 and 4-1BB bispecific antibody givastomig exerts antitumor activity through CLDN18.2-expressing tumor-directed T-cell activation" in the latest issue of The Journal for Immuno-Therapy of Cancer (JITC).
Moderna signs deal in Shanghai with view to developing mRNA medicines
Vaccine maker Moderna Inc (MRNA.O) said on Wednesday it had signed a memorandum of understanding and a land collaboration agreement to work towards opportunities for it to research, develop and manufacture mRNA medicines in China.
Pfizer to end development of experimental obesity pill due to elevated liver enzymes
Pfizer on Monday said it would stop developing its experimental obesity and diabetes pill, lotiglipron, due to elevated liver enzymes in patients who took the drug once a day in midstage clinical studies.
Regulatory logjam in China offshore listings hits firms’ funding plans
Chinese companies are finding it challenging to get timely regulatory approvals for overseas share offerings as scrutiny of their proposals has intensified under new listing rules, frustrating potential issuers and investment bankers.
China’s Shein denies U.S. IPO rumors
Chinese fast fashion giant Shein on Friday denied a Reuters report that said it has confidentially filed for an initial public offering in the U.S.
FDA Approves First Cellular Therapy to Treat Patients with Type 1 Diabetes
Today, the U.S. Food and Drug Administration approved Lantidra, the first allogeneic (donor) pancreatic islet cellular therapy made from deceased donor pancreatic cells for the treatment of type 1 diabetes.
HUTCHMED to Announce 2023 Half-Year Financial Results
HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM; SEHK:13) will be announcing its interim results for the six months ended June 30, 2023 on Monday, July 31, 2023 at 7:00 am Eastern Daylight Time (EDT) / 12:00 noon British Summer Time (BST) / 7:00 pm Hong Kong Time (HKT).
