HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Dec. 13, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (œHUTCHMED) (Nasdaq/AIM:‹HCM, HKEX:‹13) today announces that under the 2023 simple...
Hong Kong-based Hutchmed announced Monday the FDA asked it to complete a “multi-region” trial in pancreatic and extra-pancreatic neuroendocrine tumors before the agency will approve surufatinib. The company had completed two Phase 3 trials in China, as well as a “bridging” trial in the U.S. in an effort to prove the drug would be similarly effective in U.S. patients.
Hutchmed (China) Limited (Hutchmed) has nannounced that following the 2021 negotiations with the China National nHealthcare Security Administration (NHSA) on January 1, 2022, the nupdated National Reimbursement Drug List (NRDL) will continue to includenElunate (fruquintinib) and will now include Sulanda (surufatinib) also.
HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM; HKEX: 13) today announces that it has initiated SURTORI-01, a Phase III study to evaluate the efficacy and safety of surufatinib (SULANDA® in China) in combination with toripalimab compared with FOLFIRI to treat patients with advanced neuroendocrine carcinoma (“NEC”) who have progression of disease or intolerable toxicity after previous first-line chemotherapy. The first patient was dosed on September 18, 2021 in China. Toripalimab is marketed as TUOYI® in China by Shanghai Junshi Biosciences Co., Ltd. (“Junshi Biosciences”).
HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., July 01, 2021 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM; HKEX: 13) today announces that the U.S. Food and Drug Administration (“FDA”) has accepted its filing of the New Drug Application (“NDA”) for surufatinib for the treatment of pancreatic and extra-pancreatic (non-pancreatic) neuroendocrine tumors (“NETs”). The Prescription Drug User Fee Act (PDUFA) goal date assigned by the FDA for this NDA is April 30, 2022.
HUTCHMED Announces NMPA Approval of Surufatinib (Sulanda in China)
Hutchison China MediTech (Chi-Med) announced that surufatinib has been granted approval for drug registration by the National Medical Products Administration of China (NMPA) for the treatment of non-pancreatic neuroendocrine tumors (NETs). Surufatinib will be marketed in China under the brand name Sulanda. Surufatinib is Chi-Med’s first self-discovered oncology drug to be approved in China without the support of a development partner, and follows the approval of Chi-Med’s first oncology drug, Elunate (fruquintinib capsules), in 2018.
Hong Kong, Shanghai, & Florham Park, NJ: Wednesday, December 30, 2020: Hutchison China MediTech Limited (“Chi-Med”) (Nasdaq/AIM: HCM) today announces that surufatinib has been granted approval for drug registration by the National Medical Products Administration of China (“NMPA”) for the treatment of non-pancreatic neuroendocrine tumors (“NETs”). Surufatinib will be marketed in China under the brand name Sulanda®. Surufatinib is Chi-Med’s first self-discovered oncology drug to be approved in China without the support of a development partner, and follows the approval of Chi-Med’s first oncology drug, Elunate® (fruquintinib capsules), in 2018.
The filing of a new drug application (NDA) has been initiated with the FDA for surufatinib for the treatment of patients with pancreatic and non-pancreatic neuroendocrine tumors.1
The filing of a new drug application (NDA) has been initiated with the FDA for surufatinib for the treatment of patients with pancreatic and non-pancreatic neuroendocrine tumors.1