Takeda is investing heavily in plasma-derived therapy amid rapid growth. Daiichi Sankyo and AstraZeneca spinout Dizal Pharma revealed promising lung cancer data at the European Society for Medical Oncology (ESMO) congress 2022 that are supporting their plans for further tests. President Joe Biden launched a biomanufacturing initiative, which is widely viewed as a response to China's growing industry. And more.
1. Takeda splashes €300M to expand plasma-derived therapy production site amid pandemic recovery
Takeda will invest 300 million euros ($300 million) to build a new production facility and a warehouse at its existing plasma-derived therapies site in Lessines, Belgium. The new project has a focus on digital tools and Takeda’s net zero carbon emissions target by 2030. The announcement comes as Takeda’s plasma collection has recently returned to pre-pandemic levels.
2. ESMO: Daiichi dazzles in lung cancer to dial up hopes for next ADC
Daiichi Sankyo unveiled new data from its B7-H3-directed antibody-drug conjugate, DS-7300, at ESMO. In a phase 1/2 trial, DS-7300 triggered a 58% response rate in 19 patients with small cell lung cancer. The responses lasted a median 5.5 months. Daiichi started a phase 2 trial in the summer to further examine the drug in small cell lung cancer.
3. ESMO: AstraZeneca spinout Dizal planning phase 3 NSCLC study in US before year-end
China’s Dizal Pharma, a spinout from AstraZeneca, plans to start a U.S. phase 3 trial of its EGFR inhibitor sunvozertinib in non-small cell lung cancer based on a phase 2 win, CEO Xiaolin Zhang, Ph.D., told Fierce Biotech at the ESMO congress. In the midstage trial, the drug shrunk tumors in nearly 60% of 97 patients, a showing the CEO believes sets the bar for potential competitors.
4. Biden looks to beef up US biomanufacturing amid pressure from China
President Joe Biden has issued an executive order that aims to boost biotechnology and biomanufacturing in the U.S. The order, with a big focus on biosecurity, was viewed as a reaction to increased competition from China. Major Chinese CDMOs like WuXi Biologics saw their stock prices tumble on the news.
5. Asymchem, Snapdragon’s US-China CDMO deal derailed by foreign investment regulator (release)
Amid the news of Biden’s biomanufacturing initiative, the U.S. Treasury’s Committee on Foreign Investment in the United States has effectively blocked a proposed $58 million acquisition of Massachusetts-based Snapdragon Chemistry by Chinese CDMO giant Asymchem. The two firms couldn’t agree on mitigation terms that would satisfy the U.S. regulator.
5. Gilead settles 5 more Descovy patent feuds, pushing copycats to its PrEP successor out to 2031
Gilead Sciences has settled patent disputes with five generics makers—Lupin, Apotex, Macleods, Hetero Labs and Cipla—around the company’s popular HIV med tenofovir alafenamide, which is used in branded drugs Vemlidy, Descovy and Odefsey. Under the deals, those companies’ copycats of the three Gilead products won’t roll out until late 2031 or early 2032.
6. After 'watershed' approval, Takeda nears dengue vaccine launch and gears up for more green lights
Takeda expects more approvals down the line for its dengue vaccine TAK-003, which just got its first nod in Indonesia under the brand name Qdenga, program head Derek Wallace told Fierce Pharma. The company is seeking parallel approvals in multiple endemic countries and with the European Medicines Agency.
Other news of note
8. Chinese vaccine developer Recbio taps OCT Clinical for COVID-19 shot trial