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君實生物：海外監管公告 - 上海君實生物醫藥科技股份有限公司自願披露關於特瑞普利單抗二線及以上治療黑色素瘤獲得國家藥品監督管理局常規批准的公告

JUNSHI BIO: Overseas regulatory announcement - JUNSHI BIO Technology Co., Ltd. voluntarily discloses the announcement regarding the regular approval from the National Medical Products Administration for Treprilir Monoclonal Antibody for second-line and above treatment of melanoma.

HKEX ·  Jan 6 18:15

Summary by Moomoo AI

君實生物宣布，其特瑞普利單抗（商品名：拓益®）用於治療既往接受全身系統治療失敗的不可切除或轉移性黑色素瘤的適應症，已由附條件批准轉為常規批准。此次批准主要基於MELATORCH研究結果，該研究顯示特瑞普利單抗相較達卡巴嗪可顯著延長無進展生存期，降低疾病進展或死亡風險29.2%。特瑞普利單抗是中國首個獲批上市的國產PD-1單抗藥物，目前已在中國內地獲批10項適應症，全部納入國家醫保目錄。在國際化佈局方面，該藥已在美國、歐盟等多個國家和地區獲批上市。此外，公司正在全球開展覆蓋超過15個適應症的40多項臨床研究，並已提交特瑞普利單抗用於一線治療不可切除或轉移性黑色素瘤的新適應症上市申請。值得注意的是，黑色素瘤雖在中國相對少見，但病死率高，2022年新發病例約0.9萬，死亡病例達約0.5萬。特瑞普利單抗的常規批准為此類患者提供了新的治療選擇。然而，藥品的商業化仍可能受到當地政策、市場環境變化等因素影響，存在一定不確定性。
君實生物宣布，其特瑞普利單抗（商品名：拓益®）用於治療既往接受全身系統治療失敗的不可切除或轉移性黑色素瘤的適應症，已由附條件批准轉為常規批准。此次批准主要基於MELATORCH研究結果，該研究顯示特瑞普利單抗相較達卡巴嗪可顯著延長無進展生存期，降低疾病進展或死亡風險29.2%。特瑞普利單抗是中國首個獲批上市的國產PD-1單抗藥物，目前已在中國內地獲批10項適應症，全部納入國家醫保目錄。在國際化佈局方面，該藥已在美國、歐盟等多個國家和地區獲批上市。此外，公司正在全球開展覆蓋超過15個適應症的40多項臨床研究，並已提交特瑞普利單抗用於一線治療不可切除或轉移性黑色素瘤的新適應症上市申請。值得注意的是，黑色素瘤雖在中國相對少見，但病死率高，2022年新發病例約0.9萬，死亡病例達約0.5萬。特瑞普利單抗的常規批准為此類患者提供了新的治療選擇。然而，藥品的商業化仍可能受到當地政策、市場環境變化等因素影響，存在一定不確定性。
JUNSHI BIO announced that its Trerixumab (brand name: Tuoyi®) for the treatment of unresectable or metastatic melanoma that has failed prior systemic therapy has been converted from conditional approval to regular approval. This approval is primarily based on the results of the MELATORCH study, which showed that Trerixumab significantly extends progression-free survival compared to Dacarbazine, reducing the risk of disease progression or death by 29.2%.Trerixumab is China's first domestically approved PD-1 monoclonal antibody drug and is currently approved for 10 indications in mainland China, all of which are included in the national medical insurance catalog. In terms of international expansion, the drug has been approved for sale in the USA, EU, and several other countries and regions. Additionally, the...Show More
JUNSHI BIO announced that its Trerixumab (brand name: Tuoyi®) for the treatment of unresectable or metastatic melanoma that has failed prior systemic therapy has been converted from conditional approval to regular approval. This approval is primarily based on the results of the MELATORCH study, which showed that Trerixumab significantly extends progression-free survival compared to Dacarbazine, reducing the risk of disease progression or death by 29.2%.Trerixumab is China's first domestically approved PD-1 monoclonal antibody drug and is currently approved for 10 indications in mainland China, all of which are included in the national medical insurance catalog. In terms of international expansion, the drug has been approved for sale in the USA, EU, and several other countries and regions. Additionally, the company is conducting over 40 clinical studies globally covering more than 15 indications and has submitted a new indication application for Trerixumab for first-line treatment of unresectable or metastatic melanoma.It's worth noting that although melanoma is relatively rare in China, its mortality rate is high, with approximately 0.009 million new cases and about 0.005 million deaths in 2022. The regular approval of Trerixumab provides new treatment options for such patients. However, the commercialization of the Pharmaceutical may still be affected by local policies, market environment changes, and other factors, resulting in certain uncertainties.

This announcement is a separate document:

Doc 1

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