Chinese CDMO Genscript faces a customs probe in China, and law enforcement slapped custodial measures on the chairman and newly appointed CEO of its subsidiary Legend Biotech. AstraZeneca tapped Samsung Biologics in a $331 million deal to help it make biologic drugs. Fujifilm's flu drug Avigan helped non-severe COVID-19 pneumonia patients recover faster in a phase 3 trial. And more.
1. J&J CAR-T partner Legend's new CEO under 'residential surveillance' after Chinese customs raid
Fangliang “Frank” Zhang, chairman of Chinese CDMO Genscript and recently appointed CEO of its subsidiary Legend Biotech, has been put under “residential surveillance” by China law enforcement. The move came after China’s Customs Anti-Smuggling Department raided Genscript’s businesses in the cities of Nanjing and Zhenjiang, including Legend’s office. Legend is known for its CAR-T partnership with Johnson & Johnson.
2. AstraZeneca, Samsung reach $331M biologics manufacturing deal amid Korean CMO's expansion push
Samsung Biologics won a $331 million deal to produce drug products to support AstraZeneca’s biologics therapeutics. The multiyear deal can be expanded to $546 million. Neither party specified which products would be included.
3. Fujifilm's flu drug Avigan improves COVID-19 recovery time, setting up filing in Japan
After a delay, Fujifilm’s phase 3 trial pitting its flu drug Avigan against coronavirus has finally read out. The drug helped patients with non-severe COVID-19 pneumonia recover faster, as defined by a negative COVID-19 test and relief from symptoms. Those who got Avigan recovered after a median 11.9 days, compared with 14.7 days for the placebo group. The company’s now seeking approval in Japan.
Merck and Eisai’s Keytruda-Lenvima combo showed promise in several head-to-treat cancer types. In previously treated triple-negative breast cancer, the combo triggered a response in 29% of patients. Meanwhile, 32.3% of ovarian cancer patients who had tried three prior options and 21.9% of non-microsatellite instability-high colorectal cancer patients recorded responses to the pair in a basket study called Leap-005.
5. Astellas, Seattle Genetics' Padcev bladder cancer trial stops early with 30% death risk reduction
Seattle Genetics and its partner Astellas revealed that their antibody-drug conjugate, Padcev, slashed the risk of death by 30% over chemo in a study of bladder cancer patients who had tried but failed on platinum-based chemo and a PD-1/L1 inhibitor. One analyst expects the survival benefit to “raise the bar” for its ADC competitor Trodelvy, which will soon be part of Gilead Sciences.
6. ESMO: Chi-Med's surufatinib gears up to challenge Novartis, Pfizer with placebo-topping phase 3
Chi-Med’s surufatinib staved off disease progression for a median 10.9 months among Chinese patients with pancreatic neuroendocrine tumors in a phase 3 trial, significantly beating the 3.7 months posted by the placebo group. The company hopes data from this pancreatic NET trial and a previously announced positive study in non-pancreatic NET, as well as global trials, can earn it an FDA approval to challenge Novartis’ Afinitor and Pfizer’s Sutent.
7. Brii hires Gilead's China general manager Luo to drive expansion
Gilead Sciences' China head, Yongqing “Rogers” Luo, has jumped ship to young Sino-American biotech Brii Biosciences as president and China general manager. Luo almost single-handedly built Gilead’s China operations after joining in 2016, having helped the company win approvals for eight drugs there and put four products—Vemlidy, Epclusa, Harvoni and Genvoya—on the National Reimbursement Drug List.
8. Sun Pharma the latest to recall metformin after carcinogen tests come up positive
Sun Pharma has become the seventh drugmaker to initiate a voluntary recall of metformin because of high levels of a potential cancer-causing contaminant. The Indian company recalled one lot of 747 bottles of its Riomet ER, an extended-release version of the common diabetes med, after finding high levels of NDMA.
9. Takeda taps Foundation Medicine for lung cancer companion diagnostics
Takeda tapped Roche’s Foundation Medicine to develop tissue- and blood-based companion diagnostic tests for its portfolio of lung cancer therapies. These include genomic tests for ALK inhibitor Alunbrig and the investigational drug mobocertinib (TAK-788) for non-small cell lung cancer with EGFR exon 20 insertions.
10. China's Viva Biotech snaps up Hong Kong CRO SYNthesis to boost preclinical offering
Shanghai-based Viva Biotech is shelling out $80 million to acquire Hong Kong-based preclinical CRO SYNthesis, which focuses on pharmaceutical chemistry and synthetic chemistry services.