Fierce Pharma Asia—AstraZeneca China spinoff report; Takeda's Vyvanse shortage; Enzene's New Jersey plant

AstraZeneca has reportedly drafted a contingency plan to spin out its China business amid increasing geopolitical risks. The British pharma is still forming collaborations in the country, the latest being an R&D pact focused on hypercholesterolemia. Takeda is experiencing a shortage of attention-deficit/hyperactivity disorder med Vyvanse. And more.

1. 'Misinformation': AstraZeneca's China head refutes news report about potential spinoff

AstraZeneca has devised a plan to potentially spin its China business into a separate entity listed either in Hong Kong or Shanghai, the Financial Times reports. The British pharma is preparing to protect its remaining business if China cracks down on foreign companies, according to the FT. But in response to Chinese media outlet Yicai, AZ’s international and China president Leon Wang called the report “misinformation.”

2. AstraZeneca returns to hypercholesterolemia via R&D pact with fresh-faced Chinese biotech

Meanwhile, AstraZeneca formed a three-year R&D pact with Shanghai-based Cholesgen to study potential drug targets in hypercholesterolemia and related metabolic diseases. The Chinese biotech was founded in 2021 and recently raised $14 million in a series A with participation from a joint investment fund set up by AstraZeneca and state-backed China International Capital Corporation.

3. As Adderall shortages persist, Takeda's rival Vyvanse is now in short supply

Takeda’s attention-deficit/hyperactivity disorder drug Vyvanse is in short supply after a manufacturing delay compounded by increased demand, the company said. Supply shortfalls for two higher dose forms of the drug are expected to continue into September, the company said. The Vyvanse problem comes amid a shortage of the popular ADHD drug Adderall and its generics.

4. India's Enzene Biosciences unveils $50M New Jersey plant project, plans to hire 300

Enzene Biosciences plans to open a $50 million manufacturing facility near Princeton, New Jersey. The CDMO, a subsidiary of India’s Alkem Laboratories, could hire as many as 300 new workers at the site. The plant, the company’s first in the U.S., is expected to be fully operational by June 2024 and will make biologics.

5. FDA inspectors ding one Dr. Reddy's plant in India, clear another

An FDA inspection of Dr. Reddy’s formulations plant in Srikakulma, India, ended with a notice of Voluntary Action Indicated, which indicates problems that aren’t serious enough to warrant any regulatory action. A separate visit at the company’s API facility in Bollaram, India, found no observations, the company said in a filing.

6. Aslan sells Japanese rights to would-be Dupixent rival for $12M

Aslan Pharmaceuticals out-licensed Japanese rights to its IL-13 receptor antibody eblasakimab to Zenyaku Kogyo for $12 million upfront. The midphase eczema candidate is targeting Sanofi’s blockbuster Dupixent. Both drugs block IL-4 and IL-13 signaling. Aslan argues its drug could more efficiently block IL-13 and thereby potentially have improved dose frequency and efficacy.

Other news of note

7. Lupin wins approval for first US generic of Boehringer Ingelheim's COPD blockbuster Spiriva

8. I-Mab taps former Aerie helmsman Kannan as its CEO (release)

9. SK’s COVID vaccine wins WHO emergency use listing (release)