China, Pharma

Star drugs like BMS’ Opdivo, AstraZeneca’s Lynparza will get speedy OKs in China this year, new report predicts

Now that China has revamped its drug review process to speed things up for developers, a new report predicts that Bristol-Myers Squibb $BMY, AstraZeneca $AZN and Amgen $AMGN are among the leading multinational pharma giants that will win approval for some blockbuster hopefuls. Others stand to benefit from marketing drugs developed by Chinese partners.

The report, produced by Beijing-based data provider PharmCube, highlights 16 products Chinese regulators are expected to green light in 2018. Over half of them involve an overseas player in biopharma.

The report came out just ahead of the CFDA’s updated set of guidelines for a priority review pathway, continuing an emphasis on speeding reviews and new drug approvals spotlighted throughout last year. Companies can now seek priority review of drug candidates that meet one of a list of criteria, or prove effective in treating several major diseases. And a host of key outfits are rushing in to see how they can begin to capitalize on the booming Chinese health care market.

On track to be China’s first PD-1/PD-L1 checkpoint treatment, BMS’ Opdivo (nivolumab) is high up on the list. The application was accepted in November and granted priority review in December. The hopes for a speedy approval is high given its clinical benefits and the attention it has garnered (not to mention that the biologic queue is relatively short). Considering AstraZeneca’s lung cancer drug Tagrisso was OK’d within three weeks of getting accelerated review, a Q1 approval does not seem far-fetched.

AstraZeneca is cheering on its own Lynparza for ovarian cancer, which was the first imported drug to include international multicenter data in its application. PharmCube is looking at a Q3 approval for this one, given that it does get fast-tracked.

In the fourth quarter there’s Amgen’s Repatha (evolocumab) and Novartis’ Zykadia (ceritinib) — which lowers cholesterol and treats lung cancer, respectively. And if things go smoothly, Eli Lilly will pocket a good chunk of revenue from marketing fruquintinib, a product developed by China’s Hutchison MediPharma, which lays claim to being the first true home grown drug to aim at a marketing launch. It treats colorectal cancer, the second-most prevalent cancer in China.

Here’s the full list:

  1. Frontier Biotech: albuvertide
  2. Bristol Myers-Squibb: nivolumab
  3. Jiangsu Hengrui Medicine: 19K
  4. CTTQ: anlotinib hydrochloride
  5. Jiangsu Hengrui Medicine: pyrotinib
  6. Hutchinson MediPharm/Eli Lilly: fruquintinib
  7. AstraZeneca: Lynparza  (olaparib)
  8. Eisai: Lenvima (lenvatinib)
  9. FibroGen/AZ: roxadustat
  10. Hansoh: PEX168
  11. Novartis: Zykadia (ceritinib)
  12. Amgen: Repatha (evolocumab)
  13. Ascletis: danoprevir
  14. Gilead: Harvoni (ledipasvir/sofosbuvir)
  15. Eli Lilly: Trulicity (dulaglutide)
  16. Gilead: Vemlidy (tenofovir alafenamide)


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VP Oncology Biology
Skyhawk Therapeutics Waltham, MA
Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT

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