106 documents

Read All
19:24 , May 17, 2019 |  BioCentury  |  Product Development

Pushing China to the forefront: When a first-in-China regulatory strategy makes sense

As reforms in China shorten clinical and regulatory timelines for biotechs across the board, the country has a growing chance to become the first stop for regulatory approvals of first-in-class drugs. The decision to do...
Read More
23:41 , Apr 19, 2019 |  BioCentury  |  Product Development

Companies poised to take Chinese checkpoints global

At least three companies are well positioned to answer FDA Oncology chief Richard Pazdur’s call to bring Chinese PD-1/PD-L1 inhibitors to the U.S. to compete on price. Two Chinese drugmakers and one U.S. company globally...
Read More
18:24 , Apr 5, 2019 |  BioCentury  |  Product Development

Pazdur on pandemonium: calls for collaboration, competition on PD-1 drugs

In separate sessions at AACR, FDA’s Oncology chief Richard Pazdur’s pointed comments and questions to PD-1/PD-L1 companies made it clear that he thinks patients are getting hurt from pharmas’ failure to collaborate and the high...
Read More
21:50 , Apr 3, 2019 |  BC Extra  |  Politics & Policy

FDA's Pazdur encourages Chinese companies to bring low-cost PD-1 drugs to U.S. market

Richard Pazdur, director of FDA’s Oncology Center of Excellence, is urging Chinese companies to bring PD-1/PD-L1 inhibitors to the U.S. market and undercut the prices charged by multinational pharmas. Chinese companies competing in the U.S....
Read More
22:18 , Mar 13, 2019 |  BC Extra  |  Politics & Policy

China releases timeline, priority diseases for revised reimbursement list

China's National Medical Insurance Administration released its plan for issuing a revised National Drug Reimbursement List Wednesday, describing which types of drugs will have priority for inclusion and sketching out a timeline for a revision...
Read More
22:55 , Mar 6, 2019 |  BC Extra  |  Company News

Report: China’s Innovent prices domestic PD-1 inhibitor at smaller discount than Junshi

Innovent priced its anti-PD-1 mAb Tyvyt in China at a discount compared with the China price of Keytruda, but a premium to the price of fellow domestic PD-1 inhibitor Tuoyi from Junshi Biosciences, according to...
Read More
02:40 , Feb 28, 2019 |  BC Week In Review  |  Financial News

CStone raises $285M in Hong Kong IPO

CStone Pharmaceuticals Co. Ltd. (HKSE:2616) priced its IPO on the Hong Kong stock exchange Feb. 25, raising HK$2.2 billion (US$285 million). The oncology company rose HK$0.86 to HK$12.86 in its first day of trading Feb....
Read More
15:01 , Feb 26, 2019 |  BC Extra  |  Financial News

First-day gain for CStone on Hong Kong exchange

CStone Pharmaceuticals Co. Ltd. (HKSE:2616) rose HK$0.86 to HK$12.86 in its first day of trading Tuesday after raising HK$2.2 billion ($285 million) in its IPO. The oncology company priced the offering early Monday near the...
Read More
05:32 , Feb 25, 2019 |  BC Extra  |  Financial News

CStone raises $285M in Hong Kong IPO

CStone Pharmaceuticals Co. Ltd. (HKSE:2616) priced its IPO on the Hong Kong stock exchange early Monday, raising HK$2.2 billion (US$285 million). The offering values CStone at HK$11.8 billion (US$1.5 billion). CStone sold 18.6 million shares...
Read More
01:03 , Jan 12, 2019 |  BioCentury  |  Finance

Warning: cash needed

  A near decade-long run of cheap money appears to be coming to a close, and most of the biotech sector isn’t well positioned for the new reality. BioCentury’s analysis shows that two-thirds of biotech...
Read More