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.
Now that Amazon, JPMorgan Chase, and Berkshire Hathaway have their healthcare sandbox to play in, guess who is a lot further along? Nope, not Dr. Feelgood, it’s the Chinese. According to a recent NY Times article, “tech companies like Alibaba and Tencent have made health care a priority for years, and are using China as their laboratory. After testing online medical advice and drug tracking systems, they are now focused on a more advanced tool: artificial intelligence.” A few tidbits about health in China = 1.5 doctors for every 1,000 people (~half the US), largest number of obese children in the world, and they have more diabetes patients (110 million) than anywhere else. And money is flowing everywhere. Tencent, the internet giant, is reportedly plowing tens of millions into American health tech start-ups. If you’re a person, this is good news, as more tech should equal better health.
This week, Chinese researchers successfully cloned two genetically identical long-tailed macaques (aka monkeys). Using a technique called somatic cell nuclear transfer animation (SCNT), scientists started with 79 embryos and implanted them in 21 female surrogates that resulted in 6 pregnancies and the births of the 2 monkeys. Mice, sheep (remember Dolly?), pigs, now monkeys. What’s the difference? According to many scientists, the successful cloning of primates is a huge step in learning more about complex animals, like humans. This advancement also reinvigorates the discussion around the ethical aspect of medical research and we’re not going to go there. InsightCity would have named one of the monkeys “Brass” just so we could play the song, but that’s just us. Thanks for reading. You’ve been patient and we know what monkey clip you’ve been waiting for, so here it is. Enjoy.