SHANGHAI – Innovent Biologics Inc., of Suzhou, has raised $260 million from government-backed and independent investors in what is the largest financing round ever for a private biopharma in China. The deal is also the second largest for the sector globally this year.

SHANGHAI – During the ChinaTrials meeting in Shanghai last week it was clear that many China biopharmas view entering the U.S. market as necessary for long-term success. When looking ahead, they lack confidence the China market will sufficiently reward investments in new drugs. Even after sweeping regulatory reforms have been made in biopharma’s favor, reimbursement remains an issue.

SHANGHAI – At the Clinical Trials 9 event last week, it was clear the biopharma industry’s optimism has not been dented by the recent CFDA rejection of 1,200 applications – about 70 percent of its workload – for poor quality or fraudulent data. While one would think so many questionable drug applications would cast a pall on the industry, especially among clinical trial experts, that is not exactly the case.

SHANGHAI – During the ChinaTrials meeting in Shanghai last week it was clear that many China biopharmas view entering the U.S. market as necessary for long-term success. When looking ahead, they lack confidence the China market will sufficiently reward investments in new drugs. Even after sweeping regulatory reforms have been made in biopharma's favor, reimbursement remains an issue.

SHANGHAI – At the Clinical Trials 9 event last week, it was clear the biopharma industry's optimism has not been dented by the recent CFDA rejection of 1,200 applications – about 70 percent of its workload – for poor quality or fraudulent data. While one would think so many questionable drug applications would cast a pall on the industry, especially among clinical trial experts, that is not exactly the case.

SUZHOU, China – Ruyi He, chief scientist of the CFDA and the Centre for Drug Evaluation (CDE), outlined the government's commitment to streamline and speed up the review process for innovative drugs, sharing support for more dynamic communication between reviewers and sponsors. He joined the CFDA/CDE in July after more than a decade with the U.S. FDA.

SHANGHAI – China's most productive biosimilar developer, Suzhou Alphamab Co. Ltd., is deepening its biologics manufacturing footprint by setting up Alphamab (Jiangsu) Biopharmaceuticals Co. Ltd. – an export-focused plant in Suzhou. In spite of China's new market authorization holder (MAH) rules – permitting the use of contract manufacturing – Suzhou Alphamab is taking the plunge to invest heavily in the complex task of biologics manufacturing.

SUZHOU, China – Ruyi He, chief scientist of the CFDA and the Centre for Drug Evaluation (CDE), outlined the government's commitment to streamline and speed up the review process for innovative drugs, sharing support for more dynamic communication between reviewers and sponsors.

SHANGHAI – Starting out with a bang, newly formed biopharma Cstone Pharmaceuticals Co. Ltd. has filed an investigative new drug application with the Jiangsu FDA for its recombinant anti-PD-L1 monoclonal antibody (WBP3155). The firm now awaits approval from the regulators before it can study the PD-L1 antibody in Chinese patients.