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RSS FeedPosted by Michael Wonder on 29 Mar 2026
Enhertu followed by THP approved in China as the first and only HER2 directed ADC for the neo-adjuvant treatment of HER2 positive breast cancer
27 March 2026 - First approval of Daiichi Sankyo and AstraZeneca’s Enhertu globally in curative intent early breast cancer setting. ...
Posted by Michael Wonder on 27 Jan 2026
Libevitug approved in China as first in class treatment for hepatitis D
27 January 2026 - Huahui Health announced that China NMPA has granted conditional approval to its Libevitug injection for the treatment ...
Posted by Michael Wonder on 23 Jan 2026
Enhertu approved in China as the first and only HER2 directed ADC for the second-line treatment of patients with HER2 positive metastatic gastric cancer
22 January 2026 - Based on DESTINY-Gastric04 Phase 3 trial results that showed Enhertu demonstrated a statistically significant and clinically ...
Posted by Michael Wonder on 06 Jan 2026
Bayer receives breakthrough therapy designation in the US and China for sevabertinib as a first-line treatment for patients with HER2-mutant non-small cell lung cancer
6 January 2026 - Bayer receives breakthrough therapy designation in the US and China for sevabertinib as a first-line treatment for ...
Posted by Michael Wonder on 26 Nov 2025
Chinese pharma is on the cusp of going global
23 November 2025 - Its fast moving, cut price drugmakers stand to make more money abroad than at home. ...
Posted by Michael Wonder on 26 Aug 2025
Datroway approved in China for patients with previously treated metastatic HR positive, HER2 negative breast cancer
25 August 2025 - First approval in China for Daiichi Sankyo and AstraZeneca’s Datroway based on TROPIONBreast01 results showing 37% reduction ...
Posted by Michael Wonder on 30 Jan 2025
Depemokimab applications accepted for review in China and Japan for asthma with type 2 inflammation and CRSwNP
28 January 2025 - Submissions based on data from positive SWIFT and ANCHOR trials. ...
Posted by Michael Wonder on 21 Jan 2025
Anti-PD-L1 tagitanlimab approved for marketing by the National Medical Products Administration
20 January 2025 - The board of directors of Sichuan Kelun-Biotech Biopharmaceutical is pleased to announce that the Company received ...
Posted by Michael Wonder on 17 Jan 2025
Senaparib approved by NMPA for first-line maintenance therapy in ovarian cancer
16 January 2025 - Impact Therapeutics is pleased to announce that senaparib capsules has received marketing authorisation in China from ...
Posted by Michael Wonder on 15 Jan 2025
Sarclisa obtains first approval in China for the treatment of adult patients with relapsed or refractory multiple myeloma
13 January 2025 - Approval based on positive pivotal ICARIA-MM Phase 3 study using the China-based IsaFiRsT real world study as ...
Posted by Michael Wonder on 13 Jan 2025
Bayer submits application to US FDA and to China’s CDE for new indication of finerenone for patients with common form of heart failure with high unmet medical need
10 January 2025 - Regulatory submissions are based on positive data from the Phase 3 FINEARTS-HF study recently presented at ESC ...
Posted by Michael Wonder on 08 Jan 2025
China's National Medical Products Administration approves Padcev in combination with Keytruda (pembrolizumab) for the treatment of advanced bladder cancer
8 January 2025 - NMPA approval based on the global Phase 3 EV-302 trial (also known as KEYNOTE-A39) where the ...
Posted by Michael Wonder on 07 Jan 2025
Nuvation Bio receives approval from China’s National Medical Products Administration for taletrectinib for patients with advanced ROS1 positive non-small cell lung cancer
6 January 2025 - Taletrectinib will be marketed in China by Innovent Biologics. ...
Posted by Michael Wonder on 06 Jan 2025
China's National Medical Products Administration approves Vyloy (zolbetuximab) for first-line treatment of advanced gastric or gastro-oesophageal junction adenocarcinoma
5 January 2024 - Treatment with the claudin 18.2 targeted monoclonal antibody shown to significantly extend both progression-free survival and ...
Posted by Michael Wonder on 03 Jan 2025
GSK’s Nucala (mepolizumab) approved in China for treatment of adults with chronic rhinosinusitis with nasal polyps
3 January 2025 - This is the third indication for mepolizumab in China for an IL-5 mediated condition. ...