$Summit Therapeutics(SMMT.US$
Summit just in-licnesed the drug from Akeso for US, EU, Japan, etc rights. So far only Akeso annouces a postive H2H trial in China only, exact data to be seen at ASCO. the question is whether to trust a pure China developed novel molecules given China’s credibility issue in medical area
Summit just in-licnesed the drug from Akeso for US, EU, Japan, etc rights. So far only Akeso annouces a postive H2H trial in China only, exact data to be seen at ASCO. the question is whether to trust a pure China developed novel molecules given China’s credibility issue in medical area
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m850331OP Jaguar8: It doesn’t seem like that from SMMT PR and original BD agreement. SMMT may write up the clinical plan, but as a tiny biotech in the US they are very unlikely to have the capability of running a China trial.
m850331OP KingNY-Life: US FDA is already a very aggressive regulatory agency vs EMA, and China FDA follows very single setup and procedures that US FDA does
m850331OP MayFlower: 1. Tiotropium was developed by BI/Pfizer with Brand name Spiriva. And this one belongs to LAMAs which has several market drugs. Big Pharma markets some drugs in the US/EU market first and then may choose to go to China market, where they need a local China Ph III. This has been the standard to develop China market ever since China opens its market. The China trial is only useful in China drug market application, no other market (not even HK or TW). And the China trial basically copies the succesful protocols of the US/EU registrational trial. However, this is not the case for SMMT/Akeso.
2. Here we tallking about FIRST
m850331OP MayFlower: 2. Here we tallking about FIRST-IN-CLASS drug. If you want to give a counter case, tiotropium is not the one, but a CD38 CART from Nanjing Legend, which later out-license to Janssen for ex-China rights. This is so far the only novel drug solely developed by China companies that can eventually launch in the US/EU market.
3. About the fake data issue about China trials, you may want to see the numerous cases were found during 2015-2016 period that CFDA campian asked Pharma, biotechs, NROs, etc in China to self-inspectd for data issues
m850331OP MayFlower: And finally, you may want to check the so-called China NO.1 noval drug company, Jiangsu Hengrui. Their record for US/EU out-licensing deals. All of them ended up cancelled by the US/EU pattnarship companies b/c issues did not match the original data shared by Hengrui. And if you have full confidence in China developed drugs, just use them when you or your family sick, it will be win-win for you b/c it is really cheap and really “effective"
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