Wave of Pharmaceutical Innovations Lands in September: Multiple Blockbuster Products Benefit Domestic Patients
China's pharmaceutical sector marked a breakthrough September as regulators fast-tracked approvals across multiple therapeutic areas, signaling accelerated access to cutting-edge treatments for domestic patients.
The National Medical Products Administration (NMPA) greenlit a wave of innovative drugs and medical devices covering hematologic cancers, mental health, pediatric infections, cardiovascular emergencies, rare disease screening, and neuro-intervention—reflecting Beijing's push to diversify its medical innovation portfolio.
Blood Cancer Drug Leads Approvals
On September 30, the NMPA granted conditional approval to Bristol-Myers Squibb's CelmoD-class oral drug epoetamine hydrochloride capsules (brand name: Zanfu) for adult multiple myeloma patients who have received at least one prior treatment including a proteasome inhibitor and an immunomodulatory agent.
The drug, used in combination with daratumumab and dexamethasone, works by binding to cereblon protein and triggering deep degradation of Ikaros/Aiolos proteins—inducing myeloma cell death while remodeling the immune microenvironment to activate T cells and natural killer cells.
Multiple myeloma, a malignancy originating from plasma cells, affects thousands of Chinese patients annually. The new therapy offers a mechanism distinct from existing treatments and demonstrates synergistic potential when combined with immunotherapy.
Domestic Innovation Expands
The September approvals also highlighted growing strength in homegrown pharmaceuticals. Sinopharm Group Tongjitang (Guizhou) Pharmaceutical secured approval for Xingpi Jieyu Tablets, a Class 1.1 traditional Chinese medicine innovation targeting mild to moderate depression—a condition affecting an estimated 95 million Chinese adults.
In pediatric infectious disease prevention, two monoclonal antibody injections received regulatory clearance on September 3:
Ruitewebai monoclonal antibody injection (brand name: Xintuduo) from Zhuhai TaiNuoMaiBo Pharmaceutical, indicated for newborns and infants entering or born during the first respiratory syncytial virus (RSV) epidemic season
Kulaiwebai monoclonal antibody injection (brand name: Yingmule) from Ruiyang (Shandong) Biopharmaceutical, targeting infants with gestational age of 35 weeks or more, excluding those with chronic lung disease or congenital respiratory abnormalities
RSV is a leading cause of lower respiratory tract infections in infants, often resulting in hospitalization during peak epidemic seasons.
Cardiovascular and hematology treatments also saw advances. Milestone Pharmaceuticals' Equitami nasal spray (brand name: Xingbituo) won approval for acute episodes of paroxysmal supraventricular tachycardia (PSVT) in adults, while Genzyme Corporation's Rizabutinib tablets (brand name: Sailingzhi) received clearance for adult patients with persistent or chronic primary immune thrombocytopenia (ITP) who had inadequate response to prior glucocorticoid or immunoglobulin therapies.
Medical Devices Fill Clinical Gaps
Late September also brought breakthroughs in innovative medical devices across three specialized areas.
On September 29, Wuxi Leiming Shikang Technology received approval for a posterior chamber phakic intraocular lens—a one-piece, foldable device made from hydroxyethyl methacrylate and ethylene glycol dimethacrylate polymer with UV absorber. The single-focus, aspheric design corrects myopia ranging from -2.75D to -18.00D in adults, with improved imaging quality under large pupil conditions.
Two days earlier, Shanghai Jieyi Biotechnology's neonatal TREC/KREC gene detection kit (fluorescent PCR method) gained regulatory clearance. The kit uses multiplex fluorescent quantitative PCR technology to detect TREC and KREC genes in dried blood spot samples, enabling screening for severe combined immunodeficiency (SCID)—a rare but life-threatening primary immunodeficiency disorder.
This marks the first domestically produced product for SCID screening in China, facilitating early clinical intervention for affected newborns.
On September 28, B. Braun Medical (Suzhou) secured approval for a paclitaxel drug-coated intracranial balloon dilation catheter. During balloon expansion, the drug coating releases paclitaxel into the vessel wall, where it is absorbed by intimal cells. Unlike traditional stents, the procedure introduces no permanent implant, offering an alternative for symptomatic intracranial atherosclerotic severe stenosis patients unresponsive to drug therapy.
Diversified Innovation Landscape
The September approvals span imported drugs with novel mechanisms, domestic traditional Chinese medicine innovations, and high-end medical devices—illustrating China's multi-track approach to pharmaceutical advancement.
As innovative therapies and devices continue reaching the market, China's clinical treatment infrastructure is expected to strengthen further, enhancing diagnostic and therapeutic capabilities for complex diseases, rare conditions, and chronic illnesses—bringing cutting-edge solutions closer to patients nationwide.