share_log

中國生物製藥：自願公告 - 鹽酸安羅替尼膠囊、抗PD-L1「貝莫蘇拜單抗(TQB2450注射液）」新適應症上市申請獲得受理

SINO BIOPHARM: VOLUNTARY ANNOUNCEMENT - ACCEPTANCE OF THE NEW INDICATION APPLICATION FOR MARKETING OF ANLOTINIB HYDROCHLORIDE CAPSULES AND ANTI PD-L1 "BENMELSTOBART (TQB2450 INJECTION)"

香港交易所 ·  Feb 28 03:38
Summary by Moomoo AI
中國生物製藥有限公司宣佈，其附屬公司正大天晴藥業集團股份有限公司開發的兩款藥物：鹽酸安羅替尼膠囊和抗PD-L1「貝莫蘇拜單抗(TQB2450注射液）」，新適應症上市申請已獲中國國家藥品監督管理局藥品審評中心受理。該適應症為治療既往接受過一、二線化療方案治療失敗或不能耐受的非微衛星高度不穩定或非DNA錯配修復缺陷的復發性或轉移性子宮內膜癌。貝莫蘇拜單抗是一款全新序列的創新全人源化抗PD-L1單克隆抗體，而鹽酸安羅替尼膠囊則是一款口服新型小分子多靶點酪氨酸激酶抑制劑。這兩款藥物的聯合應用有望成為中國首個獲批用於該類子宮內膜癌的治療方案，並正在開展多項臨床III期試驗。中國生物製藥將持續推進這些藥物的開發，以滿足臨床需求並造福患者。公告日期為2024年2月28日。
中國生物製藥有限公司宣佈，其附屬公司正大天晴藥業集團股份有限公司開發的兩款藥物：鹽酸安羅替尼膠囊和抗PD-L1「貝莫蘇拜單抗(TQB2450注射液）」，新適應症上市申請已獲中國國家藥品監督管理局藥品審評中心受理。該適應症為治療既往接受過一、二線化療方案治療失敗或不能耐受的非微衛星高度不穩定或非DNA錯配修復缺陷的復發性或轉移性子宮內膜癌。貝莫蘇拜單抗是一款全新序列的創新全人源化抗PD-L1單克隆抗體，而鹽酸安羅替尼膠囊則是一款口服新型小分子多靶點酪氨酸激酶抑制劑。這兩款藥物的聯合應用有望成為中國首個獲批用於該類子宮內膜癌的治療方案，並正在開展多項臨床III期試驗。中國生物製藥將持續推進這些藥物的開發，以滿足臨床需求並造福患者。公告日期為2024年2月28日。
CHINA BIOPHARMACEUTICAL CO., LTD. ANNOUNCES THE DEVELOPMENT OF TWO DRUGS BY ITS SUBSIDIARY CHENGDAI TIANCHING PHARMACEUTICAL GROUP CO., LTD.: ALOTINIC HYDROCHLORIDE CAPSULE AND ANTI-PD-L1 “BEMOSUBAYANANTIN (TQB2450 INJECTION)”. THE NEW INDICATIVE LISTING APPLICATION HAS BEEN RECEIVED BY THE CHINA NATIONAL DRUG ADMINISTRATION Accepted by the Quality Review Center. It is indicated for the treatment of recurrent or metastatic endometrial cancers with non-microsatellite highly unstable or non-DNA mismatch repair defects that have either failed or cannot be tolerated by 1- and 2-line chemotherapy regimens. Bemosubainide is an innovative fully humanized anti-PD-L1 monoclonal antibody of a new series, while alotinic hydrochloride capsule is an oral novel small molecule multi-target tyrosine kinase inhibitor. The combined application of the two drugs is expected to be China's first approved treatment for endometrial cancer and several Phase III clinical trials are underway. China Biopharmaceuticals will continue to advance the development of these drugs to meet clinical needs and benefit patients. The announcement date is 28 February 2024.
CHINA BIOPHARMACEUTICAL CO., LTD. ANNOUNCES THE DEVELOPMENT OF TWO DRUGS BY ITS SUBSIDIARY CHENGDAI TIANCHING PHARMACEUTICAL GROUP CO., LTD.: ALOTINIC HYDROCHLORIDE CAPSULE AND ANTI-PD-L1 “BEMOSUBAYANANTIN (TQB2450 INJECTION)”. THE NEW INDICATIVE LISTING APPLICATION HAS BEEN RECEIVED BY THE CHINA NATIONAL DRUG ADMINISTRATION Accepted by the Quality Review Center. It is indicated for the treatment of recurrent or metastatic endometrial cancers with non-microsatellite highly unstable or non-DNA mismatch repair defects that have either failed or cannot be tolerated by 1- and 2-line chemotherapy regimens. Bemosubainide is an innovative fully humanized anti-PD-L1 monoclonal antibody of a new series, while alotinic hydrochloride capsule is an oral novel small molecule multi-target tyrosine kinase inhibitor. The combined application of the two drugs is expected to be China's first approved treatment for endometrial cancer and several Phase III clinical trials are underway. China Biopharmaceuticals will continue to advance the development of these drugs to meet clinical needs and benefit patients. The announcement date is 28 February 2024.
Helpful
Not Helpful

This announcement is a separate document:

Doc 1     View Translation

Disclaimer: This content is for informational and educational purposes only and does not constitute a recommendation or endorsement of any specific investment or investment strategy. Read more