We’re sure someone said that once, but if not, we’ll be putting a TM on it soon. It’s hard to go through the full legal process to get a trademark, so we’ll likely take the easy way out. Like China. Harsh, maybe. True of the whole country, nope. Scientific reputation is very fragile. You’ve all heard of the Chinese scientist who altered the DNA in vitro of human embryos (who, by the way, is now missing.) A report from Stanford suggests that “a new emphasis on such “constructive vigilance” (towards China) is the best way to begin to protect (US) democratic traditions, institutions, and nation…” China’s CFDA “revealed that between January 2015 and January 2016, 1,184 drug applications (73%) submitted were rejected or withdrawn due to incomplete or fraudulent clinical data.” All this at a time when China is growing its clinical trial capabilities. Repeat after me – “vigilance.”
Gene editing probably won’t make the next Spiderman, but it’s possible that the world’s first gene-edited babies have been born. He Jiankui, a Chinese scientist, shocked the world and its ethical sensibilities by revealing last week that he used CRISPR to lower two twin girls’ risk of HIV infection. And a third baby is on the way. Less HIV is certainly something we can all get behind, especially when World AIDS Day was last week. But CRISPR is still brand-spanking new, and scientists are questioning the medical appropriateness of this use of gene editing when the consequences aren’t super well understood and possibly catastrophic. Even a CRISPR co-founder is calling for a moratorium on live-embryo testing. Is this a breakthrough like the first IVF birth, or a slippery slope? From Nature: six questions that remain.
Sometimes you want to get a head start when starting a new company. And sometimes you get caught by the feds for stealing trade secrets. Former GSK scientist Yu Xue pleaded guilty to conspiring to do just that when starting her own biopharmaceutical company in China while still employed by the pharma giant. Prosecutors say Xue transferred documents related to products under development, research data, as well as GSK’s R&D and manufacturing processes to her colleagues in China. Xue, on top of serving up to 10 years in prison, could also be forced to pay restitution to GSK. The court graciously capped that at a reasonable number for a single person to pay, just $2B. Fun fact: that’s larger than the GDP of 26 nations according to the World Bank.
Not being concerned with pesky ethics concerns, China is pulling ahead in applying genetic editing technology towards therapeutic uses. Not content with being the first to edit monkeys, non-viable embryos, or sticking the first edited cells into a live human, a recent study showed Chinese researchers were able to fix a disease-causing mutation in viable embryos. They used base editing, which is slightly different from Crispr editing (easy-to-digest visual here), to replace the gene which causes Marfan Syndrome. The disease is typically incurable, so there’s obviously some appeal for pushing science’s boundaries for such positive results. Attitudes towards embryo editing may be changing in western nations, but don’t expect base editing to be used therapeutically for some time still.
Chinese parents are understandably angry after the emergence of a third vaccine safety scandal in about as many years. Regulators announced last Friday that Changsheng Bio-tech (which ironically means “long life” in Chinese) had sold over 250k low-quality DPT vaccines to a Chinese public health agency responsible for 100M citizens. Hey, at least that’s better than the over 400k subpar DPT vaccines produced by a different Chinese manufacturer which authorities uncovered last November. Or the spoiled vaccines illegally sold in 24 provinces in 2016. Authorities are also sick of the scandals, so on Wednesday they announced an audit of China’s entire vaccine production system. Until that’s done, you might not see consumers springing for vaccines Made in China for a bit.
Chinese pharma market:
Source: IQVIA via CNBC
We’re sure you all remember that in December of 2017 InsightCity reported that “if you wanted to hold a commercial drug license in China, you had to manufacture the product using only in-house facilities. Yep, no outsourcing of drug manufacturing.” Sounds like us. As an update, this week STA Pharmaceutical, a subsidiary of WuXi AppTec, reported they were the first CMO to get regulatory approval to manufacture a commercial drug in China. For a nice summary of China’s Marketing Authorisation Holder (MAH) program from the Economist, go here. What’s next? Well, if we look into our crystal ball, this has to fully open the doors to increased business for CDMOs, provide flexibility for innovator companies in China, and open the door to smaller innovator companies that couldn’t afford their own manufacturing facilities in China. In essence, we’re talking about a land grab.
It’s a decent time to be a Contract Development & Manufacturing Organization (CDMO). Google “CDMO expansion” and you’ll spend hours sifting through recent and relevant articles about how CDMOs are expanding, merging, and/or acquiring assets. Recently, one of the industry’s largest CDMOs (WuXi AppTec) raised more than $353m in its initial public offering on China’s Shanghai exchange. Here are two good sources for recent activity in the CDMO space: 2017 DCAT summary and one from 2018. For a more graphical summary of CDMO activities, see this infographic. And if that’s not enough, here’s one example of a recent 1,000-person expansion from Lonza at their New Hampshire site. Given all the activity in the industry, we don’t see a way around the fact that soon CDMOs will have Mo’ Money, Mo’ Money.