Genakumab

As the domestic biotech industry matures, China has given birth to increasingly more first-in-class drug assets, some of which have become sources for global innovation. China’s National Medical Products Administration (NMPA) has approved four new drugs developed by local biopharma companies, including a first-of-its-kind molecule in blood cancer.Wednesday, Chinese regulators announced (Chinese) the conditional approval of ifupinostat (BEBT-908) for treating diffuse large B-cell lymphoma (DLBCL) patients who have tried at least two prior lines of therapy.The drug, developed by BeBetter Med, is now the first HDAC/PI3K dual-targeted inhibitor approved anywhere, even though the U.S. FDA has approved multiple drugs separately targeting the two types of enzymes in blood cancers.Massachusetts-based Curis had previously been working on an HDAC/PI3K candidate called fimepinostat, which in 2018 earned an FDA “Fast Track” designation in third-line DLBCL. But the company shelved the program to put all its resources behind emavusertib, a potential first-in-class IRAK4 inhibitor, also in B-cell malignancies.A novel mechanism doesn’t necessarily mean better efficacy. In a pivotal phase 2b study, ifupinostat yielded an overall response rate (ORR) of 33.8%, according to BeBetter. After excluding patient loss to follow-up and protocol deviations caused by the COVID-19 pandemic, the ORR was 53.6%. But the number is lower than the roughly 70% posted by Gilead Sciences’ CD19 CAR-T therapy Yescarta in the Zuma-1 trial. Importantly, cross-trial comparisons come with intrinsic flaws such as differences in baseline patient characteristics.Nevertheless, ifupinostat delivered an adjusted 67% ORR in patients who had failed CAR-T and bispecific antibodies, according to BeBetter.Besides, as a small molecule drug, ifupinostat will be priced significantly cheaper than CAR-T and T-cell engagers, BeBetter noted.The company is conducting a confirmatory phase 3 trial to turn ifupinostat’s conditional nod into a full approval. The study is combining ifupinostat with rituximab in second-line DLBCL. In an exploratory phase 1b study, the combo achieved a 76.2% ORR as second-line treatment, according to results presented at this year’s American Society of Clinical Oncology meeting.As China's biotech industry matures, the country has given birth to an increasing number of first-in-class drug assets, some of which have become sources for global innovation. These include Akeso’s ivonesimab, which in 2024 became the world’s first approved PD-1xVEGF bispecific antibody thanks to a Chinese nod in EGFR-mutated nonsquamous non-small cell lung cancer.The PD-(L)1xVEGF mechanism gained prominence after ivonescimab’s phase 3 head-to-head success against Merck & Co.’s Keytruda in a Chinese population of patients with first-line NSCLC. Merck, Bristol Myers Squibb and Pfizer have since added to the fanfare with potential multibillion-dollar licensing deals all surrounding candidates developed in China. Also on Wednesday, the NMPA cleared China’s eighth CDK4/6 inhibitor, Betta Pharma’s tibremciclib, to be used alongside fulvestrant in HR-positive, HER2-negative breast cancer following progression on endocrine therapy. The drug has a similar structure to Eli Lilly’s Verzenio but with less inhibition of CDK9.In a China phase 3 trial, the addition of tibremciclib to fulvestrant led to a 69% reduction in the risk of progression or death compared with fulvestrant alone.In a third new cancer drug approval by NMPA, the agency greenlighted Simcere’s anti-VEGF antibody suvemcitug for use alongside chemotherapy for ovarian cancer patients who have tried no more than one line of therapy after developing resistance to platinum-based chemo.The drug proved its worth in a China phase 3 trial coded Scores carried out in patients with platinum-resistant ovarian cancer. Patients in the suvemcitug arm had a 54% lower chance of progression or death versus those in the placebo group, according to data released at least year’s ASCO meeting. Overall survival data were immature but favored the suvemcitug arm with a preliminary 21% death risk reduction.At that time, investigators noted that Scores was the first double-blinded phase 3 trial demonstrating the efficacy of an anti-angiogenic agent in platinum-resistant ovarian cancer. Outside of oncology, the NMPA cleared Changchun GeneScience Pharmaceutical’s firsekibart (formerly genakumab) for certain patients with acute gouty flares. To be eligible, patients must be unable to tolerate or respond to non-steroidal anti-inflammatory drugs and colchicine, and they must not be suitable to receive steroid hormones repeatedly.The drug blocks IL-1β, the same target of Novartis’ Ilaris, which secured its own gout flares nod from the U.S. FDA in 2023, making it the first biologic therapy in the indication. Ilaris is not approved in China.