Welcome to the first edition of our FiercePharmaAsia weekly wrap-up. Scientists led by oncologist Lu You at Sichuan University in Chengdu, China, have beaten out several U.S. academics and biotechs to become the first to test CRISPR-Cas9 in humans. GlaxoSmithKline’s bribery scandal in China has not settled down yet as private investigator couple Peter Humphrey and Yu Yingzeng have sued the company for misleading them about an investigation of a suspected whistleblower. Pfizer and AstraZeneca did best in emerging markets, especially with smooth operations in China, while Big Pharma together enjoyed an optimistic 3.6% growth in that market in Q3. Takeda is carrying out a 20,000-patient Phase III study in Asia and Latin America for its dengue vax candidate, which an exec says demonstrates a unit with a "global footprint." Japan has slashed the price of Bristol-Myers Squibb’s Opdivo in half. Japanese API maker Sekisui Medical was hit with an FDA warning letter because of data integrity problems.
As reported in Nature, Chinese scientists led by oncologist Lu You at Sichuan University in Chengdu injected modified cells using CRISPR into a patient with a form of lung cancer at the West China Hospital, beating out U.S. academics and biotechs to become the first in testing new gene editing tech known as CRISPR-Cas9 in humans. “I think this is going to trigger ‘Sputnik 2.0’, a biomedical duel on progress between China and the United States, which is important since competition usually improves the end product,” said Dr. Carl June, who is also being sponsored to research on CRISPR.
Years removed from a bruising bribery scandal in China, GlaxoSmithKline seems to be gradually stepping out from that dark shadow. But private investigator couple Peter Humphrey and Yu Yingzeng, whom GSK hired to investigate a whistleblower about the bribery, have filed a lawsuit in a U.S. federal court alleging that the company had misled them about the case, ultimately leading to their imprisonment.
A few years ago, emerging markets were powerful engines heating up pharma growth. Even though they have slowed down because of economic environments in key markets such as China, Big Pharma still enjoyed a 3.6% growth in that market in Q3, up from 1.8% in Q2. Pfizer has been taking the lead with 8% growth over the past four quarters, thanks to the Hospira acquisition and growth in sterile injectable drugs. The company could see more growth as it recently got approval in China for its well-received pneumococcal vaccine Prevnar 13. AstraZeneca is also doing well, with new exec hires and partnerships to push approvals and production. GlaxoSmithKline, on the other hand, is falling behind.
Takeda is taking its experimental dengue vaccine into a massive, 20,000-patient Phase III study in Asia and Latin America. To get there, however, the company’s vax unit has had to expand its global footprint. If approved, the vaccine will pose some challenges to Sanofi’s Dengvaxia, whose sales are falling behind initial estimates.
After Japan's prime minister weighed in, officials in Japan have halved the price of Bristol-Myers Squibb's Opdivo in the country, taking the cut more than a year ahead of the med’s regularly scheduled price review. The cut is more dramatic compared with the health officials' original plan for 25%. The med’s price in Japan runs twice its U.S. tag and more than five times than in the U.K.
For the second time in recent weeks, the FDA has handed a Japanese API maker a warning letter, this time predominantly for data integrity problems at Sekisui Medical. The FDA discovered the company was not keeping results of failed tests.