As Hutchmed awaits FDA approval for surufatinib, drug gets the go-ahead in China; SCOTUS knocks back last Amarin patent bid
Chinese regulators on Friday signed off on the second approval for Hutchmed’s oncology drug surufatinib after a successful Phase III trial.
Known commercially as Sulanda in China, the drug recently approved for advanced pancreatic neuroendocrine tumors also won approval in China 7 months ago for the treatment of non-pancreatic neuroendocrine tumors.
Hutchmed CEO Christian Hogg said in a statement, “Since its launch in January this year, patients with epNETs have benefited from treatment with surufatinib through its unique mode of action by both inhibiting angiogenesis and promoting the body’s immune response against tumor cells.”
Hutchmed recently filed for a $603 million IPO in Hong Kong, which will serve as a homecoming for the company as it has been listed on the Nasdaq since 2016. The company is currently awaiting FDA review of surufatinib, which was filed in May. Hutchmed was the first Chinese company to bring an in-house oncology drug to market in that country with fruquintinib, which was approved as a third-line therapy for metastatic CRC. — Josh Sullivan
SCOTUS denies Amarin’s last bid to save patent
The Supreme Court has shot down Amarin’s last bid to win back its patents on what would have been a blockbuster heart drug.
The court denied the Irish drugmaker’s request to review an appeal’s court decision that found key patents over its fish oil-based drug were invalid. That ruling, coming nearly a year after the company showed their omega-3 tablets could prevent heart attacks and strokes, had turned what could have been an instant blockbuster into a modest commercial product that, in the US, would have to compete with generic competitors.
The appeals court ruling upheld a lower court decision from March 2020 that found that, although rival drugmakers would infringe on several claims in Amarin’s patents by marketing generics, those claims were “obvious” and invalid. — Jason Mast
China gives third OK to BeiGene’s BTK inhibitor
BeiGene is stacking up the Chinese approvals for Brukinsa.
The National Medical Products Administration has cleared the BTK inhibitor for patients with Waldenström’s macroglobulinemia who have received at least one prior therapy, now the third B-cell malignancy it’s approved to treat.
The biotech touted cardiovascular safety advantages on top of “deep and durable responses.” Even though it failed to beat J&J and AbbVie’s Imbruvica on complete response rates in the head-to-head ASPEN trial involving 229 patients, regulators decided last October that the lower rate of side effects (plus other signs of efficacy) were enough to warrant a priority review.
“Brukinsa was specifically designed by BeiGene scientists to limit off-target effects seen with first-generation BTK inhibitors and we have built a broad clinical development program to assess clinical benefit, including the head-to-head ASPEN trial,” Jane Huang, BeiGene’s CMO in hematology, said in a statement.
Outside of China, the FDA has approved Brukinsa for mantle cell lymphoma, while BeiGene is looking to carve out market share from Imbruvica on other fronts like relapsed/refractory CLL or small lymphocytic lymphoma. — Amber Tong
Rafael Pharmaceuticals gears for merger
The companies shared the news of their impending merger on Monday morning. Rafael’s lead candidate devimistat, designed to target cancer metabolic pathways, is currently in Phase III trials for metastatic pancreatic cancer and relapsed or refractory acute myeloid leukemia.
CEO Ameet Mallik, former executive VP and head of Novartis’ US oncology business, is expected to steer the company to Phase III readouts in metastatic pancreatic cancer at the end of this year, according to a statement. The drug has received fast-track designation for that indication, as well as AML.
“I am truly excited to lead the Company at this pivotal time as we advance devimistat, a pipeline in a molecule, through two Phase 3 registrational clinical trials and several Phase 1 and Phase 2 clinical trial programs in additional indications,” he said. — Nicole DeFeudis