Connect Biopharma Holding Ltd.’s IL-4Rα binding candidate, CBP-201, yielded positive data in a pivotal trial in patients with moderate to severe atopic dermatitis in China, positioning the company to engage with Chinese regulators in the next several months to discuss a potential NDA filing.
Simcere Pharmaceutical Group has out-licensed its autoimmune drug candidate SIM-0278 for all indications to Almirall SA in a deal worth up to $507 million. Simcere granted exclusive global rights to the candidate to Almirall for development and commercialization excluding mainland China, Hong Kong, Macau, and Taiwan. In return, Almirall will pay Simcere $15 million up front.
Jilin Huisheng Biopharmaceutical Co. Ltd., a non-wholly owned subsidiary of Sihuan Pharmaceutical Holdings Group Ltd., has raised ¥500 million (US$70 million) in a series A round. Huisheng, which has developed a pipeline of programs addressing both diabetes and its complications, plans to use the new funds to speed up its clinical trials and purchase manufacturing equipment, according to Che Fengsheng, executive director and chairman of Sihuan Pharma.
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.
Innocare Pharma Ltd. raised ¥2.92 billion (US$412 million) in a second listing on the Shanghai STAR Market. Its shares opened at ¥10.86 apiece, sliding 15.4% to close at ¥9.33 on the first trading day, Sept. 21. The company will use the proceeds to support cancer and autoimmune drug R&D, improve its drug development platform, build its sales network, and upgrade its information technology, said Chief Commercial Officer Jin Xiaodong.
Sino Biopharmaceutical Ltd. subsidiary Chia Tai-Tianqing Pharmaceutical Group Co. Ltd. has acquired greater China rights to lanifibranor from Inventiva SA in a deal worth up to $307 million.
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.
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.”
Shanghai Junshi Biosciences Co. Ltd. plans to raise up to ¥3.969 billion (US$570 million) by issuing no more than 70 million A shares to target subscribers on the Shanghai STAR Market.
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