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BioWorld - Wednesday, May 31, 2023
Home » Topics » Asia-Pacific » China

China
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NMPA accepts enfortumab vedotin application from Astellas

March 15, 2023
By Doris Yu
No Comments
The NMPA accepted a BLA from Astellas Pharma Inc. for enfortumab vedotin, which is designed for the treatment of patients with locally advanced or metastatic urothelial cancer who previously received treatment with a PD-1/L1 inhibitor and platinum-based chemotherapy. “In China, there were nearly 86,000 new cases of bladder cancer in 2020, and we are working with the NMPA to seek approval for enfortumab vedotin for patients with advanced stage disease,” said Ahsan Arozullah, senior vice president and head of development therapeutic areas at Astellas.
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Breast cancer cells.

Zhejiang Medicine’s anti-HER2 ADC positive in phase III; possible new drug submission up next

March 14, 2023
By Zhang Mengying
No Comments
Zhejiang Medicine Co. Ltd.’s subsidiary, Novocodex Biopharmaceuticals Inc., reported positive phase III study results for its humanized anti-HER2 monoclonal antibody-drug conjugate, ARX-788, in the treatment of patients with HER2-positive locally advanced or metastatic breast cancer in China.
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Venus Medtech moves Liwen RF China trial forward

March 14, 2023
By Doris Yu
No Comments
Venus Medtech (Hangzhou) Inc. completed the enrollment of patients for a confirmatory clinical trial using its Liwen RF ablation system for the treatment of hypertrophic cardiomyopathy (HCM), reaching 128 patients in 20 hospitals in mainland China since January 2021.
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Livzon licenses GERD drug from Onconic in $127.5M deal

March 14, 2023
By Zhang Mengying
No Comments
Livzon Pharmaceutical Group Inc. licensed rights to zastaprazan, a gastroesophageal reflux disease (GERD) treatment candidate, from Onconic Therapeutics Inc. in a $127.5 million deal. Under the agreement, Livzon, which is based in Guangdong, China, obtains the exclusive rights to develop, license, manufacture and commercialize the candidate in greater China. In turn, Seoul, Korea-based Onconic will obtain a $15 million up-front payment, and up to $112.5 million in development, licensing and commercialization milestone payments.
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Lung cancer illustration

China’s NMPA clears Shengdi’s adebrelimab for extensive SCLC

March 14, 2023
By Alfred Romann
No Comments
China’s NMPA approved Shanghai Shengdi Pharmaceutical Co. Ltd.’s adebrelimab (SHR-1316) for first-line treatment of extensive-stage small-cell lung cancer (ES-SCLC) in combination with chemotherapy. The approval in mainland China makes adebrelimab the third domestic PD-L1 monoclonal antibody to make it to the domestic market. Shanghai Shengdi is a subsidiary of Jiangsu Hengrui Medicine Co. Ltd.
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Computer chip over digital background with China flag

Agilis Robotics moves closer to developing robots for endoscopic surgery

March 10, 2023
By Doris Yu
No Comments
Agilis Robotics Ltd. completed its first test in mainland China for use of its robotic instruments, which validated their feasibility and versatility for endoscopic surgery. After simulating training for endoscopic submucosal dissection and an en bloc resection of a bladder tumor, surgeons successfully used the surgical robot to remove the artificial tumor tissue. The test results met the expected goals.
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Qdot Micro - Johnson and Johnson

Johnson & Johnson’s ablation catheter garners approval in China for atrial fibrillation

March 8, 2023
By Doris Yu
No Comments
Johnson & Johnson’s Biosense Webster division reported that its Qdot Micro diagnostic and ablation deflectable tip catheter secured approval for marketing in China from the National Medical Products Administration where options for treating arrhythmias are seeing growing demand. A radiofrequency (RF) ablation catheter, Qdot Micro reduced total ablation procedure time by nearly 90 minutes.
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Zhejiang Medicine’s anti-HER2 ADC positive in phase III; possible new drug submission up next

March 8, 2023
By Zhang Mengying
No Comments
Zhejiang Medicine Co. Ltd.’s subsidiary, Novocodex Biopharmaceuticals Inc., reported positive phase III study results for its humanized anti-HER2 monoclonal antibody-drug conjugate, ARX-788, in the treatment of patients with HER2-positive locally advanced or metastatic breast cancer in China.
Read More

Hanall’s bataclimab meets endpoints in phase III myasthenia gravis trial

March 7, 2023
By Tamra Sami
No Comments
Hanall Biopharma Co Ltd.’s batoclimab met the primary and key secondary endpoints in a pivotal phase III trial in generalized myasthenia gravis (gMG) in China, marking the first positive phase III data for the candidate globally.
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Global currency

Oricell nets $45M in series B round, eyes the global market

March 7, 2023
By Doris Yu
No Comments
Oricell Therapeutics Co. Ltd. raised $45 million in a series B1 round to expand in the U.S. market. RTW Investments LP and the Qatar Investment Authority led the financing, which followed the completion of a $125 million series B round in July 2022. Shanghai-based Oricell plans to use the new funds to support the clinical development of its lead candidates, including Oricar-017, in the U.S.
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