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FibroGen, a US-China novel drug company, and AstraZeneca announced China approval of their partnered drug for anemia, the first time an international novel drug was approved initially in China. Roxadustat is a first-in-class product approved for patients with chronic kidney disease who are on dialysis. Roxadustat was approved under China priority rules that allow rolling submissions and promise a ruling six months after the submissions are complete. The approval marks a significant step toward meeting China's goal of streamlining drug approvals for novel drugs. More details....

Stock Symbols: (NSDQ: FGEN) (NYSE: AZN)

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Shanghai Junshi Bioscience plans to raise up to $414 million in a Hong Kong IPO that will be priced later this week and begin trading on December 24. The IPO values Junshi at $1.9 billion. Seven cornerstone investors have agreed to buy $242 million of the offering. Founded in 2012, Junshi is developing immunoncology candidates and other biologics. It claims to be the first China company to file an NDA for an anti-PD-1 candidate and the first company to be approved for China tests of anti-PCSK9 and anti-BLyS mAbs. More details....

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Suzhou's CStone Pharma has filed for a Hong Kong IPO. Founded in 2015, CStone has quickly built a portfolio of 14 oncology candidates. The company says its three core products are IO drugs -- PD-1, PD-L1 and CTLA-4 antibodies -- which will be paired with other of its assets to offer combination therapies. As part of its development, CStone has in-licensed molecularly targeted compounds from Agios (a $424 million deal) and Blueprint (a $386 million, three-drug agreement), which CStone will develop in greater China. More details....

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The Shanghai Stock Exchange will set up a New Board for innovative science and technology companies, according to a statement made by China's President Xi Jinping over the weekend. With its home in Shanghai, the New Board will support the city’s development as a center of international finance. The initiative seems at least partially aimed at the market served by Hong Kong's new IPO track for pre-revenue biotechs, though the announcements did not address the critical China rule that requires IPO companies to have two years of profitability. Hong Kong does not require revenues, only late-stage development. More details....

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