▎Edited by the WuXi AppTec content team
According to the official website of the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) of China, as of January 27,January 2025At Least 17 New Drugs* Submitted for Marketing Authorization in China for the First Time，This means that they are expected to be approved for marketing in China in the near future. By combing through, the indications of these new drugsCovering various types of cancer, including lung cancer, multiple myeloma, acute myeloid leukemia, chronic myeloid leukemia, as well as schizophrenia, migraine, asthma, gout, type 2 diabetes, psoriasis, and pulmonary arterial hypertension....and many other major disease types with unmet clinical needs.This article will introduce the basic information of these new drugs based on publicly available data for readers' reference.(*The new drugs here refer to those registered by NMPA as Category 1, 3.1, and 5.1. This article only counts new drugs for their first marketing application, excluding new indications.)
Visirna: Plasminogen Activator Sodium Injection
Mechanism of Action: TargetedAPOC3Targeted Small Nucleic Acid Drugs
Indications: Familial Chylomicronemia Syndrome
On January 27, the marketing application for the Class 1 new drug, Pluxilan Sodium Injection (VSA001), was accepted by the CDE. According to a press release from Visirna, this is aLiver-targeted small interfering RNA (siRNA) drugs, which efficiently and persistently silence apolipoprotein C-III (APOC3) mRNA levels to reduce the expression of APOC3 protein, and then effectively reduce serum through both lipoprotein lipase (LPL)-dependent and -independent pathways.Triglycerides (TG)And rich in TG lipoproteins (TRL) and their degradation residue levels. Multiple clinical trials have shown that the drug has high efficiency, long-lasting TG-lowering effects, good safety, and tolerability, as well asConvenience of medication administration once every three months. The indication for this product's current marketing application is for the treatment ofFamilial Chylomicronemia Syndrome (FCS). For this indication, Pulrisilan Sodium has been included by the CDE.Breakthrough Therapies。
Akeso Biopharma: Gumokizumab
Mechanism of Action: Monoclonal Antibody Targeting IL-17
Indications: Moderate to Severe Plaque Psoriasis
On January 27, the marketing application for Akeso's Class 1 new drug, Gomucimab Injection, was accepted by the CDE.This is a monoclonal antibody (AK111) targeting IL-17 independently developed by Akeso Biopharma, which has achieved positive results in its Phase 3 clinical study for moderate to severe plaque psoriasis (PsO).The final results of long-term treatment follow-up showed that guselkumab was highly effective in maintaining long-term control and further improving the efficacy for moderate to severe plaque psoriasis: at week 52 of treatment,PASI75 response rate nearly 100%, sPGA0/1 response rate nearly 90%; PASI90 response rate over 90%., PASI100 response rate exceeds 70%. Additionally, 8 weeks after discontinuation of the drug, compared with Week 52, approximately 97% of patients maintained their responses for PASI75, PASI90, and sPGA0/1.
Hengrui Medicine: Shudi Insulin InjectionMechanism of Action:Long-acting insulin analogsIndications:Type 2 DiabetesOn January 24, Hengrui Medicine announced the submission of its Class 1 new drugSudis Insulin Injection（INS068）The listing application was accepted by the CDE, and it is proposedIndication for the treatment of adult type 2 diabetesShudi insulin injection is a long-acting insulin analog independently developed by Hengrui Medicine. It is designed based on desB30 human insulin with side chain modifications to the lysine at position B29, and is intended for once-daily subcutaneous injection to treat adult patients with type 2 diabetes, aiming to improve blood glucose control.。Mechanism of Action: CGRP Monoclonal AntibodiesIndications: Prophylactic treatment of migraineJanuary 22,Teva's申报的3.1类新药Remanezumab InjectionThe listing application has been accepted by the CDE.Fremanezumab is a humanized monoclonal antibody (mAb) that selectively binds to the calcitonin gene-related peptide (CGRP) ligand.。This product is applicable for the preventive treatment of migraine in adult patients.The ProductThere are two dosing regimens,Can be injected subcutaneously once a month (225mg）, or once every 3 months subcutaneous injection (675mg）. In addition, the product can be administered by healthcare professionals or self-administered at home by patients or caregivers. The product has previously been approved for use in the United States and the European Union.Preventive Treatment of Migraine in Adult Patients, and in 2023, it was authorized by the Guangdong Provincial Drug Administration to be implemented in the Guangdong-Hong Kong-Macao Greater Bay Area.IL-YANG PHARM：Radotinib Hydrochloride CapsulesMechanism of Action:BCR-ABL1 InhibitorIndications:Chronic Myeloid LeukemiaOn January 22, the marketing application for Radotinib Hydrochloride Capsules, a Class 5.1 new drug submitted by IL-YANG PHARM, was accepted by the CDE. Public information shows that Radotinib is a targeted therapy.Natural and Kinase Domain Mutant BCR-ABL1 Inhibitors, The product has previously been approved in South Korea for the treatment of newly diagnosed or resistant to other TKI drugs chronic phase chronic myeloid leukemia (CML-CP).Daiichi Sankyo: Quizartinib Hydrochloride TabletsMechanism of Action: FLT3 InhibitorIndications: Acute Myeloid LeukemiaJanuary 18,The 5.1 class new drug quizzartinib hydrochloride tablets declared by Daiichi Sankyo（quizartinib）Marketing application approved by CDEAcceptance. This isAn orally administered, selective FLT3 inhibitor, which was approved by the US FDA in July 2023 for treatmentWithFLT3-ITDIt is used for three treatment phases of AML patients — induction, consolidation, and maintenance therapy — in newly diagnosed acute myeloid leukemia (AML) adult patients who are mutation-positive.。Bristol-Myers Squibb, Zai Lab: Timalin Trospium Chloride CapsulesMechanism of Action:M1/M4 Muscarinic Acetylcholine Receptor Agonist/Muscarinic Receptor Antagonist
Indications: SchizophreniaJanuary 18,The listing application for the Class 5.1 new drug, Cholinesterase Inhibitor Trospium Chloride Capsules, co-submitted by Bristol-Myers Squibb and Zai Lab, has been accepted by the CDE.AcceptanceAccording to the press release issued by Zai Lab, this isFor the treatment of schizophreniaThe new drug KarXT, forAOral M1/M4 Muscarinic Acetylcholine Receptor AgonistAndCombination of Muscarinic Receptor Antagonists. In September 2024, the U.S. FDA hadApprovalThis product is used to treat adult schizophrenia.At that timeThe FDA press release pointed out,This is targetedThe first antipsychotic drug targeting cholinergic receptors,Also marks the first new mechanism drug for treating schizophrenia in decades.。Zai Lab has reached an exclusive licensing agreement with Karuna Therapeutics (acquired by Bristol-Myers Squibb) to gain the rights for the development, manufacturing, and commercialization of KarXT in Greater China.Milestone Pharmaceuticals, Jixing Pharmaceuticals: Etripamil Nasal Spray
Mechanism of Action: Novel Calcium Channel Blocker
Indications: Paroxysmal Supraventricular Tachycardia
On January 18, the marketing application for etripamil nasal spray, a Class 1 new drug jointly submitted by Milestone Pharmaceuticals and Jixing Pharmaceuticals, was accepted by the CDE. According to the press release from Jixing Pharmaceuticals,This is a fast-acting non-dihydropyridine L-type calcium channel blocker (CCB),The indication for this marketing application is the treatment of paroxysmal supraventricular tachycardia (PSVT).Patients can, in an environment without medical supervision (for example, at home), throughAiqupamiNasal spray self-administration for the rapid termination of acute PSVT episodes. In May 2021, Jixing Pharmaceuticals and Milestone entered into an exclusive licensing agreement, granting Jixing exclusive rights to develop and commercialize etripamil for the treatment of PSVT and other cardiovascular diseases in Greater China.
Menarini, SciClone Pharmaceuticals:Meropenem-VaborbactamMechanism of Action: Antibiotic Combination ProductsIndications:Complicated Urinary Tract Infections (including pyelonephritis)January 15,Menarini and SciClone Pharmaceuticals Jointly Filed Class 5.1 New DrugMarketing Application for Meropenem-Vaborbactam InjectionAccepted by CDE. This is an antibiotic compound preparation,ByCarbapenem Antibiotic MeropenemAndA Novel Boronic Acid β-Lactamase Inhibitor, Vaborbactam (Vaborbactam）Composition, the indication for this marketing application isComplicated Urinary Tract Infections (including pyelonephritis)。Saisheng Pharmaceutical reached a licensing and cooperation agreement with Menarini Asia-Pacific in August 2022, granting it the exclusive rights to develop and commercialize the product in China.Boehringer Ingelheim, China Biologic Products: Zongletinib TabletsMechanism of Action: Oral HER2 Small Molecule InhibitorIndications: HER2-Activated Mutation Non-Small Cell Lung CancerOn January 15, the CDE website announced that Boehringer Ingelheim（Boehringer Ingelheim）DeclaredZongletinib TabletsThe listing application has been accepted and included in the priority review by the CDE, with the indication for treatment.Carrying HER2 (ERBB2) with activating mutations who have previously received systemic therapy for unresectable or metastatic non-small cell lung cancer (NSCLC) in adult patients。Zongertinib (zongertinib,BI 1810631) is aOral selective HER2 tyrosine kinase inhibitor (TKI),Improved selectivity of HER2 TKIs may lead to better tolerability and efficacy.China Biopharmaceutical passed in April 2024 throughCooperationCollaborate with Boehringer Ingelheim to research, develop, and commercialize multiple oncology drug pipelines in mainland China, including this one.Zongletinib。Daiichi Sankyo: Pexidartinib Hydrochloride CapsulesMechanism of Action:CSF1R Small Molecule InhibitorIndications:Symptomatic Tenosynovial Giant Cell TumorOn January 15, Daiichi Sankyo's申报的5.1类新药Pimitinib Hydrochloride Capsules(PLX3397)The listing application has been accepted by the CDE. This listing application has been included in the priority review by the CDE.Indications for TreatmentAdult patients with symptomatic tenosynovial giant cell tumor (TGCT) accompanied by severe lesions or functional limitations that cannot be improved through surgery.。Pexidartinib (pexidartinib）YesA CSF1R small molecule inhibitor, itIt also inhibits the activity of c-kit and FLT3-ITD.。The CSF1R-mediated signaling pathway is a key driver of abnormal cell proliferation in the synovium.ZhiXiang JinTai: Selewevimab
Mechanism of Action: Bispecific Antibody
Indications: Passive Immunization for Rabies
On January 14, the marketing application for ZRGT's Class 1 new drug, Selewevimab Injection, was accepted by the CDE. According to the press release from ZRGT, this is a self-developed product of the company.Recombinant fully human bispecific antibody against Rabies Virus (Rabies Virus, RABV), targeting the envelope glycoprotein (Glycoprotein, G protein) of RABV.. The indication for this product's current marketing application isFor passive immunization after suspected rabies virus exposure in adults。
Hengrui Medicine: SHR4640Mechanism of Action: URAT1 InhibitorIndications:Gout with Hyperuricemia
January 9,Hengrui Medicine's Class 1 New Drug SHR4640 Tablets Accepted for Marketing Application by CDE, Indication isFor the long-term treatment of primary gout with hyperuricemia.SHR4640 tablets are produced by Hengrui Medicine.Highly selective small molecule inhibitors developed for URAT1 (urate transporter) specifically expressed in renal tubular epithelial cellsIt can inhibit the reabsorption of uric acid and promote its excretion by selectively inhibiting URAT1-mediated uric acid transport, thereby reducing blood uric acid concentration.Mechanism of Action: CD38 AntibodyIndications: Multiple MyelomaJanuary 8,The marketing application for I-Mab's Class 1 new drug, Phesetuzumab Injection, has been accepted by the CDE.Fizetumab isAn investigational human monoclonal antibody targeting CD38, for which the current marketing application is for the treatment of multiple myeloma.According to the press release from I-Mab, the Phase 3 registrational study demonstrated several advantages, including significantly reducing and alleviating infusion-related reactions compared to existing therapies, while greatly shortening infusion time (3~5 times) and showing excellent efficacy.Mechanism of Action:Long-acting IL-5 AntagonistIndications: Severe Asthma,Chronic Rhinosinusitis with Nasal PolypsJanuary 1 and January 4,GSK's申报的1类新药德莫奇单抗（depemokimab，GSK3511294) Two indication marketing applications were respectively approved by the CDEAcceptance。According to publicly available information from GSK, thisIs aLong-acting IL-5 Antagonist，It has an extended half-life,Symptoms in patients may be controlled with injections every six months.。The product has already been in treatmentSevere AsthmaAndChronic Rhinosinusitis with Nasal Polyps (CRSwNP)Positive results were achieved in four Phase 3 clinical studies.The results of these four trials will be used to support regulatory submissions worldwide.Johnson & Johnson: Macitentan Tadalafil Tablets
Mechanism of Action: Single-pill Combination
Indications: Pulmonary Arterial Hypertension
January 1, Johnson & Johnson（Johnson & Johnson）The marketing application for the Class 5.1 new drug, Macitentan Tadalafil Tablets, has been accepted by the CDE. Public information shows,This is an innovative single-tablet combination product consisting of macitentan, a dual endothelin A receptor/endothelin B receptor (ETA/ETB) antagonist, and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor.. The drug has previously beenUnited StatesApproved for marketing in the EU and China, used forLong-term treatment for adult patients with pulmonary arterial hypertension (PAH) classified as WHO Functional Class (FC) II-III。
Vifor Fresenius Medical Care Renal, Weijian Pharmaceuticals: Diazepam Injection
Mechanism of Action: KOR Agonist
Indications: Moderate to severe pruritus in adult patients undergoing hemodialysis
On January 1, the marketing application for the Class 5.1 new drug Difelikefalin Injection, submitted by Vifor Fresenius Medical Care Renal, was accepted by the CDE. Public information shows,Difelikefalin is a κ-opioid receptor (KOR) agonist that inhibits the sensation of itching by binding to the receptor. The hydrophilic peptide structure of difelikefalin restricts its entry into the central nervous system (CNS), distinguishing it from KOR agonists with central activity.. The product has been approved for marketing in countries and regions such as the United States and the European Union,For the treatment of moderate to severe pruritus associated with chronic kidney disease in adult patients undergoing hemodialysis.Weijian Pharmaceuticals and Vifor Fresenius Medical Care Renal Pharma signed a long-term exclusive licensing agreement in 2023 for the development and commercialization of the product in China to treat moderate to severe pruritus in adult patients undergoing hemodialysis.
We look forward to the smooth progress of these new drugs in the subsequent development and registration process, so that they can reach patients as soon as possible and bring them new treatment options.
[1] Official website of China National Medical Products Administration.Retrieved Jan 27, 2025. From https://www.nmpa.gov.cn/zwfw/zwfwpjfbzs/index.html[2] Official websites of various companies and publicly available information
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