Polaris Pharmaceuticals Inc.’s pegargiminase (pegylated arginine deiminase/ADI-PEG 20) met the primary endpoint of a statistically significant improvement in overall survival and the secondary endpoint of significant improvement in progression-free survival in patients enrolled in the pivotal phase II/III Atomic study in malignant pleural mesothelioma.
Inspectors from the U.S. Public Company Accounting Oversight Board (PCAOB) have reportedly arrived in Hong Kong to inspect audit records for the Chinese companies listed by the U.S. SEC as being noncompliant with U.S. accounting standards.
Lepu Medical Technology (Beijing) Co. Ltd. received marketing approval from China’s NMPA for its peripheral cutting balloon to treat peripheral arterial disease.
E-nitiate Biopharmaceuticals Co. Ltd. has raised ¥100 million (US$14.4 million) in a series A round to speed up the clinical trials of its lead assets, QY-201 and QY-101, and expand the pipeline. “Our strategy is to focus on the ‘blue ocean’ of the dermatosis market,” said Shi Jun, chief medical officer at E-nitiate Biopharma. “The first step is to enter China’s autoimmune skin diseases market.”
China has issued a slew of measures to encourage domestic developers by constraining overseas-made medical devices from entering the market. “Policies to guide medical institutions to give priority to the purchase of domestic medical devices and consumables can help Chinese manufacturers to acquire market share. This also encourages domestic manufacturers to continue improving technology to narrow the technology gap with foreign firms,” said Cai Mingzi, analyst at Kaiyuan Securities Co. Ltd., in a note.
E-nitiate Biopharmaceuticals Co. Ltd. has raised ¥100 million (US$14.4 million) in a series A round to speed up the clinical trials of its lead assets, QY-201 and QY-101, and expand the pipeline. “Our strategy is to focus on the ‘blue ocean’ of the dermatosis market,” said Shi Jun, chief medical officer at E-nitiate Biopharma. “The first step is to enter China’s autoimmune skin diseases market.”
MGI Tech Co. Ltd. raised ¥3.602 billion (US$518 million) on the Shanghai STAR Market. Shares (SHA: 688114) debuted at ¥87.18 apiece on the first trading day on Sept. 9. They closed at ¥124 per share on Sept. 14.
Neukio Biotherapeutics Co. Ltd. has raised $50 million to support preclinical validation and clinical development of new cell therapies for cancer. The series A-1 round was led by CD Capital, Beijing Alwin Asset Management Co. Ltd. and Surplus Capital, with contributions from previous investors Lilly Asia Ventures, Sherpa Healthcare Partners Co. Ltd., and IDG Capital.
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