It is a drug with Chinese only data so far
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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MayFlower : biased comments.
MayFlower : To my knowledge, There was a medication named Tiotropium in patients with COPD, and the clinical trial was done in China. Now this medication has been widely accepted globally including western rich countries.
KingNY-Life MayFlower : Ignore him; this biased statement is not based on science but on politics.
Jaguar8 : It was SMMT who carried out the Harmoni-a clinical trial in China. It was not China who carried out the trial but rather sample population were Chinese. Akeso will just be the marketing channel of the product in China.
74458991 ingrid : Jaguar I’m Ingrid 74458991. I’ve just sent you a friend request as I’m looking for some advice re EJH. Hope you can help me . Thanks
KingNY-Life Jaguar8 : These dying patients were lucky to have experienced this kind of experiment. Their lives continued. It's not a bad thing. America'sfdaIt's too bureaucratized to provide an umbrella for those big pharmaceutical groups, but I believe the US market will pass approval sooner or later.
m850331 OP 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.
m850331 OP 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
m850331 OP 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
m850331 OP 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
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