China released a new list of state-covered drugs after pharmaceutical companies offered steep price concessions. Sun Pharma shelled out $576 million to acquire an alopecia candidate that's nearing an FDA submission. CDMO giant GenScript raised $224 million for its biologics subsidiary. And more.
1. AbbVie, Novartis and more win national coverage in China even as Pfizer's Paxlovid gets left out
After China’s latest round of national reimbursement negotiations, more than 100 drugs landed spots on the country’s state health insurance scheme at average discounts of around 60%. AbbVie’s Rinvoq, Novartis’ Kesimpta, Roche’s Evrysdi, Takeda’s Takhzyro and many others secured spots. Pfizer’s COVID drug Paxlovid didn’t get in, and neither did a PD-1 inhibitor by Fosun Pharma’s Henlius Biotech.
2. Concert joins Sun Pharma’s symphony for $576M with aim of bringing alopecia treatment to market
Sun Pharma wants a piece of the alopecia market, and it’s buying a company to reach that goal. For $576 million, the Indian company is acquiring Concert Pharma for the latter’s JAK candidate deuruxolitinib. With a positive phase 3 readout in hand, Sun plans to file an FDA application in the first half of 2023. If approved, the drug would go against Eli Lilly and Incyte’s Olumiant.
3. China's GenScript conjures $224M in investor cash for its biologics contractor ProBio
GenScript’s biologics CDMO subsidiary ProBio raised $224 million in a series C to “build up manufacturing capacity, further research and development capabilities and opportunistically acquire assets.” Legend Capital led the financing round.
4. Entering J&J's fiefdom, Luye wins FDA approval of long-acting schizophrenia drug
China’s Luye Pharma has won FDA approval for Rykindo, an extended-release injectable formulation of decades-old risperidone, to treat schizophrenia and bipolar I disorder. Luye’s version uses microsphere technology to extend the dosing frequency to once every two weeks. The company will compete against Johnson & Johnson, which has a portfolio of similar long-acting drugs.
5. Servier, Taiho score in phase 3 colorectal cancer trial to support Lonsurf combo nod
Otsuka’s Taiho Oncology and Servier showed that adding Roche’s Avastin to their Lonsurf could pare down the risk of death by 39% over Lonsurf alone in colorectal cancer patients who had progressed on two prior chemotherapy regimens. The two companies plan to submit the results from the phase 3 SUNLIGHT trial to drug regulators in the coming months.
6. Astellas details first-in-class win for CLDN18.2 agent in stomach cancer (release)
In the first of two phase 3 wins, Astellas showed its zolbetuximab, when added to the mFOLFOX6 chemo regimen, cut the risk of death by 25% in patients with newly diagnosed Claudin18.2-positive, HER2-negative gastric or gastroesophageal junction adenocarcinoma. The SPOTLIGHT trial data, combined with a second win from the GLOW trial, sets Astellas up for a first-in-class approval in an increasingly crowded CLDN18.2 field.
7. Charles River inks gene therapy development and manufacturing pact with South Korean biopharma
South Korean company Rznomics has signed on Charles River Laboratories to help develop its liver cancer gene therapy and manufacture viral vectors. The deal centers on Rznomics’ ribozyme-based RNA editing candidate, RZ-001, which has an FDA go-ahead to begin a global phase 1/2a trial.