China’s historic drug nod, Biogen’s stepped-up biosim bet; WuXi’s expansions

In a landmark nod, China conditionally approved Merck's Gardasil 9 in just nine days based on foreign data. Days before Samsung BioLogics suffered the biggest stock slide amid accounting allegations, Biogen said it is looking to raise its stake in their joint venture, Samsung Bioepis. Right after WuXi AppTec expanded its lab testing facility in the U.S., WuXi Biologics and WuXi STA announced major expansion plans in Ireland and Shanghai, respectively. 

1. 9 days for Gardasil 9: China hands out landmark nod with lightning speed

China’s drug regulator waved through Merck’s HPV vaccine Gardasil 9 just nine days into review. It’s not just the speed that makes it a landmark event. The green light is also a conditional approval—an equivalent to the U.S.’ "accelerated approval" pathway the Chinese agency is testing—that in this case is based on foreign clinical trial data.

2. Biogen to boost stake in biosims joint venture as competition to its MS meds mounts

Biogen's CFO said the company is looking to raise its stake in Samsung Bioepis, its biosimilar joint venture with Samsung. Biogen now owns 5.4% of the JV, and the U.S. biotech is eyeing a stake of up to 49.9%, emphasizing its commitment to biosimilar development. The partnership is set to launch a Humira biosim in Europe in October; it's already selling a copycat version of Amgen’s Enbrel and a knockoff of Johnson & Johnson and Merck’s Remicade.

3. China's WuXi Biologics to build biologics plant in Ireland that will employ 400 | WuXi AppTec’s CDMO subsidiary to build new Shanghai research lab

As WuXi AppTec nears an official relisting in Shanghai, its other branches are expanding quickly. Hong Kong, S.A.R., China-listed WuXi Biologics is investing €325 million ($392 million) to build a 2.8 million-square-foot biologics facility in Ireland, its first outside of China. Its CDMO subsidiary, STA Pharmaceutical, announced plans for a new 320,000-square-foot R&D center in Shanghai.

4. Samsung BioLogics’ stock slides after regulators claim accounting rules infraction

The contract manufacturer Samsung BioLogics lost about $6 billion, or 20%, in market value Wednesday, marking its biggest intraday decline since it went public in 2016. The reason? South Korea’s securities regulators alleged that the company breached accounting rules to inflate its net profit before its IPO.

5. Refuge Biotech scores $25M from Chinese backers for ‘intelligent’ CAR-T

Refuge Biotech secured $25 million in series B funding led by 3SBio and Sequoia China. The company’s dCas9 platform uses a method of cutting DNA that's different from traditional CRISPR-Cas9. It currently has three CAR -T programs in its pipeline, and the lead investors have an exclusive option to negotiate rights to those eventual products in China.

6. UAE’s Neopharma and ASKA of Japan to build drug plant in India in $53M JV

United Arab Emirates-based drugmaker Neopharma and ASKA Pharmaceuticals of Tokyo agreed to build a $53 million manufacturing joint venture in India. The JV plans to manufacture drugs for cardiovascular diseases, the central nervous system and diabetes, along with other key therapeutic areas targeting Japan and the world market.

7. Manufacturing hiccup in China trips up Sanofi's vaccine sales momentum

Sanofi blamed a 1% vaccine sales decline in the first quarter partly on a manufacturing problem with Pentaxim in China and also on Dengvaxia’s safety controversy. Last December, several Pentaxim batches failed China’s regulatory tests and were put on temporary import hold. CEO Olivier Brandicourt said his company remains "confident of a return to growth in the second half."

8. First its offices, then its websites—what will Sinobioway seize next in the Sinovac saga?

Amid a take-private power grab at Sinovac, the Chinese vaccine maker accused Aihua Pan, the chairman of its Beijing subsidiary and chairman of Sinobioway, of tampering with its websites. That was a few days after Pan was allegedly trying to seize full control of the company by barring Sinovac workers from their offices and cutting power to the facility.

9. Big Pharma-to-biotech trend spreads to China as Pfizer China GM lands at BeiGene

Xiaobin Wu, Ph.D., recently Pfizer’s China general manager, has jumped ship to Chinese biotech star BeiGene as its president and China GM. Since taking on the Pfizer job via its 2009 Wyeth merger, Wu has helped Pfizer become a leading multinational pharma company in China. His hire is critical to BeiGene as the company enters the marketing stage with a licensing deal with Celgene.

10. India’s drug regulatory force conducts third round of raids on manufacturers

India’s drug regulatory force pulled off a third round of raids on drug facilities that were manufacturing products without approval. The latest inspection in Sikkim resulted in the cancellation of one license and suspension of another.

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