DualityBio (9606.HK) announced that its biologics license application (BLA) for DB-1303, a trastuzumab pamirtecan (T-Pam) developed in partnership with BioNTech SE (development code: BNT323, international nonproprietary name INN / USAN: Trastuzumab Pamirtecan), has been accepted by the National Medical Products Administration (NMPA) based on positive results from a pivotal Phase III clinical trial and feedback from pre-application communications with the NMPA's Center for Drug Evaluation.
The study is a randomized, controlled, open-label, multicenter Phase III clinical trial conducted in China, aimed at evaluating the efficacy and safety of the new drug DB-1303 compared to T-DM1 in HER2-positive, unresectable or metastatic breast cancer patients who have previously received trastuzumab and taxane therapy.
The new drug has shown statistically and clinically significant improvements, with good safety and tolerability.
Dr. Huai Mou, Global Chief Medical Officer of DualityBio, stated that there are over 350,000 new breast cancer patients annually in China, with a high incidence rate, ranking second among malignant tumors in Chinese women. The progress of DB-1303/T-Pam's market entry demonstrates the potential to provide effective new treatment options for breast cancer patients. In the Chinese market, DualityBio has partnered with 3SBIO to jointly promote the commercialization of DB-1303/T-Pam for multiple indications in mainland China, Hong Kong, and Macau. Globally, DualityBio will continue to deepen its strategic collaboration with BioNTech to advance the global development of this drug. As a drug developed simultaneously worldwide, DB-1303/T-Pam has strong strategic partners in both overseas and Chinese markets, and DualityBio will work together to accelerate the product's market approval process, maximizing the global clinical value of DB-1303/T-Pam and bringing more treatment options to patients worldwide as soon as possible

01530

09606

159615

DualityBio announced that its new drug DB-1303 has been accepted for listing by the National Medical Products Administration. This drug targets HER2-positive unresectable or metastatic breast cancer patients, showing significant efficacy and good safety based on the results of Phase III clinical trials. DualityBio is collaborating with 3SBIO to promote the commercialization of DB-1303 in mainland China, Hong Kong, and Macau, and will continue to deepen its global strategic cooperation with BioNTech

Tasty Money

3SBIO

DUALITYBIO-B

China Southern Hang Seng Biotech ETF(QDII)

Fullgoal Hang Seng SCHK Innovative Drug & Healthcare ETF

Hwabao WP Hang Seng SCHK Innovative Drug Select ETF

Penghua SSE STAR Biology and Medicine ETF

E Fund CSI 300 Health Care ETF

ChinaAMC CSI Biotechnology Theme ETF

E Fund Hang Seng SCHK Innovative Drug ETF

Bosera Hang Seng SCHK Innovative Drug Select ETF

ChinaAMC SSE STAR Biology and Medicine ETF

Founder Fubon CSI Medicine and Medical Device Innovation ETF

Ping An CSI Medicine and Medical Device Innovation ETF

ICBCCS SSE STAR Biology and Medicine ETF

China Merchants CSI Biotechnology Theme ETF

Guotai CSI Bio-medicine ETF

E Fund CSI Biotechnology Theme ETF

Huaan Hang Seng Biotech ETF

Yinhua CSI Innovative Drugs Industry ETF

Minsheng Royal CSI Biotechnology Theme ETF

ChinaAMC SSE Health Care ETF Initiating Fund

GF CSI HK Innovative Drugs Industry ETF(QDII)

Tianhong CNI BIOMEDICINE ETF

Penghua CSI HK Connect Health Care Composite ETF

ChinaAMC Hang Seng Biotechnology Technology ETF(QDII)

Bosera Hang Seng Health Care ETF(QDII)

DUALITYBIO's new drug application for adult breast cancer has been accepted by the National Medical Products Administration, promoting commercialization in mainland China, Hong Kong, and Macau