Innovation serves as the core engine for the high-quality development of the pharmaceutical industry and a crucial underpinning for safeguarding people's health and wellbeing.

In 2025, China's pharmaceutical sector yielded fruitful outcomes in innovation. The National Medical Products Administration (NMPA) approved a total of 76 innovative drugs for marketing, hitting a new record high. These new drugs cover multiple therapeutic areas including oncology, metabolic diseases, autoimmune diseases and rare diseases. A number of first-in-class and first-in-China drugs have filled the clinical gaps.

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Today, let usconduct a comprehensive reviewof the innovative drugs approved for marketing in 2025to explorewhere their "innovation" liesand what clinical needs they satisfy.

2025Innovative Drugs Approved for Marketing

1 Amy Metoclock Injection

Holder: Bosheng Zhuoyue Biotechnology (Beijing) Co., Ltd.

The drug was conditionally approved for marketing through the priority review and approval procedure, and was used to treat acute graft-versus-host disease with hormone therapy failure, mainly involving digestive tract over 14 years old.

2 Xiaoer Huangjin Zhike Granules

Holder: Beijing Dongfang Yunjia Pharmaceutical Co., Ltd.

The medicine has the effects of clearing away lung-heat, eliminating phlegm, suppressing lung-heat and relieving cough, and can be used for treating cough caused by phlegm-heat resistance in children with mild acute bronchitis, with red tongue and thin yellow or greasy fur.

3 Riccatidan for injection

Holder: Guangdong Hengrui Pharma Company Limited.

The indications of this drug are: on the basis of diet control, it is used in combination with statins or statins and other lipid-lowering therapies for adult patients with primary hypercholesterolemia (including heterozygous familial hypercholesterolemia and non-familial hypercholesterolemia) and mixed dyslipidemia who still cannot reach the goal of low-density lipoprotein cholesterol after receiving moderate or above doses of statins; Or used alone in adult patients with non-familial hypercholesterolemia and mixed dyslipidemia to reduce the levels of low density lipoprotein cholesterol, total cholesterol and apolipoprotein B.

4 Ploog Lieting Tablets

Holder: Unacon Ouyi Pharmaceutical Co., Ltd.

The medicine is suitable for improving the blood sugar control of adult patients with type 2 diabetes.

5 Qifangbitong Tablets

Holder: Beijing Yiling Pharmaceutical Co., Ltd.

The medicine has the effects of invigorating qi and inducing resuscitation, and can be used for improving sneezing, runny nose, nasal itching, nasal congestion, pale tongue, white fur, floating or weak pulse in patients with persistent allergic rhinitis of deficiency of both lung and spleen without seasonal allergen.

6 Lietinib tablets

Holder: Jiangsu Aosaikang Pharmaceutical Co., Ltd.

The drug is suitable for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have developed disease during or after treatment with epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) and have been confirmed to have EGFRT790M mutation.

7 Senapali capsules

Holder: Shanghai Yingpai Pharmaceutical Co., Ltd.

The drug is suitable for maintenance treatment of adult patients with advanced epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer after first-line platinum-containing chemotherapy achieves complete remission or partial remission.

8 Esupaglutide α Injection

Holder: Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.

This medicine is suitable for controlling blood sugar in adults with type 2 diabetes.

Naltansvir Phosphate Capsules

Holder: Guangdong Dongyangguang Pharmaceutical Co., Ltd.

This drug is suitable for the treatment of adult chronic hepatitis C virus (HCV) infection with or without compensatory cirrhosis after initial treatment or interferon treatment.

10 Finuoli monoclonal antibody injection

Holder: Shenzhou Cell Engineering Co., Ltd.

The drug is combined with platinum-containing chemotherapy for the first-line treatment of recurrent and/or metastatic squamous cell carcinoma of the head and neck.

11 Staduta monoclonal antibody injection

Holder: Zhuhai Tylenol Mai Bo Pharmaceutical Co., Ltd.

The drug was approved for marketing through the priority review and approval procedure for emergency prevention of tetanus in adults.

12 Compound Binafuxi Granules

Holder: Xinjiang Yinduolan Pharmaceutical Co., Ltd.

The medicine has the effect of eliminating abnormal body fluids in vivo, and can be used for treating heat-induced cold with symptoms such as fever, stuffy nose, runny nose, sore throat, headache and dry mouth.

13 enalapril tablets

Holder: Roche Pharma (Schweiz)AG

The drug combined with piperacillin and fulvestrant is suitable for adult patients with locally advanced or metastatic breast cancer who are resistant to endocrine therapy (including relapse during or after adjuvant endocrine therapy), PIK3CA mutation, hormone receptor (HR) positive and human epidermal growth factor receptor 2(HER2) negative.

14 Imaxitinib Sulfate Tablets

Holder: jiangsu hengrui Pharmaceutical Co., Ltd.

The medicine is suitable for adult patients with active ankylosing spondylitis who have poor curative effect or intolerance to one or more TNF inhibitors.

15 Mashurasavir Tablets

Holder: Jiangxi Kerui Pharmaceutical Co., Ltd.

The drug is suitable for the treatment of previously healthy adolescents and adults with simple influenza A and B, excluding patients with high risk of influenza-related complications.

16 icofosbuvir tablets:

Holder: Yichang Dongyangguang Changjiang Pharmaceutical Co., Ltd.

This medicine is suitable for the treatment of adult chronic hepatitis C virus (HCV) infection with or without compensatory liver cirrhosis after initial treatment or interferon treatment.

17 Poppet Dakeji Injection

Holder: Shanghai Xinzhi Pharmaceutical Technology Co., Ltd.

The drug was approved for marketing through the priority review and approval process, and was used to treat adult patients with moderate and severe hemophilia B (congenital coagulation factor X deficiency).

18 capecitabine tablets

Holder: AstraZeneca UKLimited

The drug is suitable for adult patients with locally advanced or metastatic breast cancer who have received at least one endocrine therapy at the metastatic stage, or who are HR-positive, HER2-negative and accompanied by one or more changes in PIK3CA/AKT1/PTEN during adjuvant therapy or within 12 months after completing adjuvant therapy.

19 Enochizumab Injection

Holder: Zhongshan Kangfang Biomedical Co., Ltd.

The medicine is suitable for other systemic treatments such as cyclosporine, methotrexate (MTX) and adult patients with moderate to severe plaque psoriasis who are unresponsive to PUVA (psoralen and ultraviolet A), contraindicated or intolerable.

20 Children's Yellow Wave Sticker Pavilion

Holder: Jianmin Pharmaceutical Group Co., Ltd.

The prescription of this medicine comes from the clinical experience of famous Chinese medicine practitioners in China, and it is attached to Dazhui point and Shenque point, with the functions of reducing fever, relieving exterior syndrome, clearing heat and detoxicating, and is used for fever (38.5°C and below) caused by wind-heat syndrome in children with acute upper respiratory tract infection.

21 Enrique injection

Holder: Haisike Pharmaceutical Group Co., Ltd.

The medicine is suitable for treating mild and moderate pain after abdominal surgery.

22 Piroxili tablets

Holder: Xuanzhu Biotechnology Co., Ltd.

The drug is suitable for adult patients with advanced or metastatic breast cancer with HR positive and HER2 negative: combined with fulvestrant for patients with disease progression after previous endocrine therapy; Monotherapy is used for patients who have received two or more endocrine therapies and one chemotherapy in the previous metastatic stage and have developed the disease.

Veratrinase β for injection

Holder: Beihai Kangcheng (Shanghai) Biotechnology Co., Ltd.

The drug has been approved for marketing through priority review and approval procedures, and is suitable for long-term enzyme replacement therapy for adolescents and adults aged 12 and over with Gaucher's disease.

24 Angradivir Tablets

Holder: Guangdong Zhongsheng Ruichuang Biotechnology Co., Ltd.

The medicine is suitable for the treatment of adult patients with simple influenza A.

25 Golerese Citrate Tablets

Holder: Shanghai Alice Pharmaceutical Technology Co., Ltd.

The drug was conditionally approved for marketing through the priority review and approval procedure, and it is suitable for adult patients with advanced non-small cell lung cancer (NSCLC) who have received at least one systematic treatment.

26 Repagliptin Metformin Tablets (I)/(II)

Holder: Shandong Shengdi Pharmaceutical Co., Ltd.

This medicine, combined with diet control and exercise, is suitable for improving blood sugar control in adult patients with type 2 diabetes who are treated with repagliptin phosphate and metformin hydrochloride.

27 Rikang Tratuzumab for Injection:

Owner: Suzhou Shengdiya Biomedical Co., Ltd.

The drug was conditionally approved for marketing through the priority review and approval procedure. The single drug is suitable for the treatment of adult patients with HER2(ERBB2) activation mutation who have received at least one systemic therapy before.

Agostigmine α for injection

Holder: Jiangsu Taikang Biomedical Co., Ltd.

The medicine is suitable for adult patients with non-myelogenous malignant tumors to reduce the incidence of infection with febrile neutropenia when receiving bone marrow inhibitory anticancer drugs that are easy to cause febrile neutropenia.

29 Yipei Growth Hormone Injection

Holder: Xiamen Tebao Bioengineering Co., Ltd.

The medicine is suitable for treating growth retardation caused by growth hormone deficiency in children aged 3 years and above.

Zenida Tozumab for Injection.

Holder: Baekje Shenzhou (Suzhou) Biotechnology Co., Ltd.

The drug was conditionally approved for marketing through priority review and approval procedures, and it is suitable for unresectable locally advanced or metastatic biliary cancer patients with high expression of HER2 (IHC3+) who have received systemic treatment before.

31 Pholopirapitam Palonosetron for Injection

Holder: Fujian Sheng Di Pharmaceutical Co., Ltd.

The medicine is used to prevent acute and delayed nausea and vomiting caused by highly emetic chemotherapy (HEC) in adults.

32 Leroxili hydrochloride tablets

Holder: genor biopharma (USA), Inc.

The drug is suitable for adult patients with locally advanced or metastatic breast cancer with positive dry HR and negative HFR2: it is used in combination with aromatase inhibitor as initial endocrine therapy; Combined with fulvestrant, it is used in patients with disease progression after previous endocrine therapy.

33 Gikaxitinib Hydrochloride Tablets

Holder: Suzhou Zejing Biopharmaceutical Co., Ltd.

The medicine is used for adult patients with moderate or high-risk primary myelofibrosis (PMF), polycythemia vera secondary myelofibrosis (PPV-MF) and primary thrombocytosis secondary myelofibrosis (PET-MF) to treat disease-related splenomegaly or disease-related symptoms.

34 Luwo Meitinib Tablets

Holder: Shanghai Fosun Pharmaceutical Industry Development Co., Ltd.

The drug was approved for marketing through the priority review and approval procedure, and is suitable for adult patients with Langerhans cell histiocytosis (LCH) and histiocytoma. Children and adolescents with type | neurofibromatosis (NF1) with symptoms and inoperable plexiform neurofibroma (PN) aged 2 years and over.

35 Vulcanic Acid Fuweixili Capsules

Holder: Jinzhou Aohong Pharmaceutical Co., Ltd

The drug combined with fulvestrant is suitable for the recurrent or metastatic adult breast cancer patients with HR-positive and HER2-negative disease progression after endocrine therapy.

36 Fenenzalutamide Soft Capsule

Holder: Haichuang Pharmaceutical Co., Ltd.

The drug is suitable for adult patients with metastatic castration-resistant prostate cancer (mCRPC) who have developed the disease after receiving abiraterone acetate and chemotherapy and have not received new androgen receptor inhibitors in the past.

37 Famitinib malate capsules

Holder: jiangsu hengrui Pharmaceutical Co., Ltd.

The drug is conditionally approved for marketing, and the combination of Karelizumab for injection is used for patients with recurrent or metastatic cervical cancer who have failed to receive platinum-containing chemotherapy before but have not received bevacizumab treatment.

38 Yangxue Qufeng Zhitong Granules

Holder: Guangdong Fangsheng Jianmeng Pharmaceutical Co., Ltd.

Indications: TCM syndrome differentiation for frequent tension-type headache belongs to deficiency of both qi and blood, characterized by recurrent headache, giddiness, anorexia, spontaneous sweating, shortness of breath, listlessness, pale complexion, pale tongue with white fur, and deep, thin and weak pulse.

39 Masdupeptide Injection

Holder: Xinda Biopharmaceutical (Suzhou) Co., Ltd.

The medicine is suitable for long-term weight control of adult patients on the basis of diet control and physical activity increase. The initial body mass index (BMI) is: BMI≥28kg/m2 (obesity); Or BMI≥24kg/m2 (overweight), accompanied by at least one weight-related complication (such as hyperglycemia, hypertension, dyslipidemia, fatty liver, obstructive sleep apnea syndrome, etc.).

Fuxinqibaizumab for injection

Holder: Changchun Jinsai Pharmaceutical Co., Ltd.

The medicine is suitable for acute attack of gouty arthritis in adults who are contraindicated, intolerant or lack of curative effect on non-steroidal anti-inflammatory drugs and/or colchicine, and are not suitable for repeated use of steroid hormones.

Epinorestat Hydrochloride for Injection

Holder: Guangzhou Bibeite Pharmaceutical Co., Ltd.

The drug was conditionally approved for marketing through the priority review and approval procedure. The single drug is suitable for adult patients with relapsed or refractory diffuse large B-cell lymphoma who have received at least two lines of systematic treatment in the past.

42 Elsouissi tazumab for injection

Holder: Jiangsu Xiansheng Biopharmaceutical Co., Ltd.

The drug is combined with paclitaxel, doxorubicin liposome or topotecan, and is used for the treatment of adult recurrent ovarian cancer, tubal cancer or primary peritoneal cancer who have received no more than one systematic treatment after platinum resistance.

Teresili Tartrate Capsules

Holder: Beida Pharmaceutical Co., Ltd.

The drug combined with fulvestrant is suitable for locally advanced or metastatic adult breast cancer patients with HR-positive and HER2-2-negative progression after previous endocrine therapy.

Smenafil hydrochloride tablets

Holder: Suzhou Wangshan Wangshui Biomedical Co., Ltd.

The medicine is suitable for treating erectile dysfunction.

45 Lee Shattock pull tab:

Owner: Suzhou Yasheng Pharmaceutical Co., Ltd.

The drug was conditionally approved for marketing through priority review and approval procedures, and it is suitable for adult patients with chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL) who have been treated by at least one systemic therapy including bruton tyrosine kinase (BTK) inhibitor.

46 Maseloxavir Tablets

Holder: Nanjing Zhengxiang Pharmaceutical Co., Ltd.

The drug is suitable for the treatment of previously healthy adult patients with simple influenza A and B, excluding patients with high risk of influenza-related complications.

Recombinant human albumin injection (rice)

Holder: Wuhan Heyuan Biotechnology Co., Ltd.

The drug was approved for marketing through the priority review and approval procedure, and it is suitable for the treatment of liver cirrhosis with hypoalbuminemia (≤30g/L).

48 Tonodafil Hydrochloride Tablets

Holder: Yangzijiang Pharmaceutical Group Co., Ltd.

The medicine is suitable for treating erectile dysfunction.

49 Raniki Orense Injection

Holder: Shanghai Hengrun Dasheng Biotechnology Co., Ltd.

The medicine is used for treating adult relapsed or refractory large B-cell lymphoma after second-line or above systematic treatment, including diffuse large B-cell lymphoma of unspecified type, diffuse large B-cell lymphoma transformed from follicular lymphoma, high-grade B-cell lymphoma with rearrangement of MYC and BCL2-2, and high-grade B-cell lymphoma of unspecified type.

50 shenpu granules

Holder: Jiangsu Kangyuan Pharmaceutical Co., Ltd.

The prescription of this medicine is derived from clinical experience, and it has the effects of invigorating qi and promoting blood circulation, clearing away damp-heat, dredging collaterals and relieving pain. It is used for chronic pelvic pain caused by sequelae of pelvic inflammatory disease, which belongs to damp-heat and blood stasis syndrome according to TCM syndrome differentiation. The symptoms are dull pain in the lower abdomen, lumbosacral swelling pain, yellow leucorrhea, aggravated abdominal pain during menstruation, chest distress, dry mouth, etc., and the tongue is fat, red in color, yellow and greasy in coating, and the pulse is thready or slippery.

51 atracurium hydrochloride tablets

Holder: Novartis Pharma Schweiz AG

The drug is conditionally approved through the priority review and approval procedure, and is used to reduce the proteinuria of adult patients with primary friend immunoglobulin A nephropathy (lgA nephropathy) who are at risk of rapid disease progression. Generally speaking, the urinary protein creatinine ratio (UPCR) of such patients is ≥ 1.5 g/g. 。

52 diroac tablets

Holder: Xuanzhu Biotechnology Co., Ltd.

This single drug is suitable for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not been treated with anaplasticlymphomakinase (ALK) inhibitors.

Dedabotezumab for injection

Holder: Daiichi Sankyo Europe GmbH

The medicine is suitable for treating adult patients with unresectable or metastatic HR-positive and HFR2-negative (IHC0, IHC1+ or IHC2+/ISH-) breast cancer who have received endocrine therapy in the past and at least first-line chemotherapy in the advanced stage.

Oral hexavalent recombinant rotavirus live attenuated vaccine (Vero cells)

Holder: Wuhan Institute of Biological Products Co., Ltd.

The drug has been approved for marketing through the priority review and approval procedures, and is suitable for preventing acute gastroenteritis in infants caused by rotavirus serotypes G1, G2, G3, G4, G8 and G9.

55 zemetostat tablets:

Holder: jiangsu hengrui Pharmaceutical Co., Ltd.

The drug was conditionally approved for marketing through priority review and approval procedures, and is suitable for adult patients with relapsed or refractory peripheral T-cell lymphoma who have received at least first-line systematic treatment in the past.

56 cases of etitinib tablets

Holder: boehringer ingelheim international gmbh

The drug was conditionally approved for marketing through the priority review and approval procedure. The single drug is suitable for the treatment of adult patients with HER2(ERBB2) activation mutation who have received at least one systemic therapy before.

57 momiste tablets

Holder: Ganzhou Hemei Pharmaceutical Co., Ltd.

The drug has been approved for marketing through the priority review and approval procedure, and is suitable for the treatment of adult patients with moderate to severe plaque psoriasis who meet the indications for phototherapy or systematic treatment.

58 Remabizine Injection

Holder: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

The drug is an exogenous fluorescent tracer for injection, which needs to be used together with the percutaneous glomerular filtration rate measuring device (TGFR) produced by MediBeacon Inc to evaluate the patients' glomerular filtration rate (GFR).

Bodotuzumab for injection

Holder: Sichuan Kelun Botai Biomedical Co., Ltd.

The drug is used for unresectable or metastatic HER2 positive adult breast cancer patients who have received one or more anti-HER2 drugs in the past.

Mevan Ertinib Maleate Tablets

Holder: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

The drug is suitable for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 21(L858R) substitution mutation.

Nanometer tablets

Holder: boehringer ingelheim international gmbh

The medicine is suitable for treating adult patients with idiopathic pulmonary fibrosis (IPF).

Vebecototuzumab 62 for injection

Holder: Lepu Biotechnology Co., Ltd.

The drug was conditionally approved for marketing through the priority review and approval procedure, and is suitable for treating adult patients with recurrent/metastatic nasopharyngeal carcinoma who failed to be treated by at least second-line systemic chemotherapy and PD-1/PDL1 inhibitors.

63 Ogtevir Sodium Capsules

Holder: Zhejiang Aisen Pharmaceutical Co., Ltd.

The drug is conditionally approved for marketing, and it is an oral small molecule drug for treating COVID-19 infection, which is used to treat adult patients with mild and moderate novel coronavirus infection (Covid-19).

64 Pukkio Rensai Injection

Holder: Chongqing Precision Biotechnology Co., Ltd.

The drug was conditionally approved for marketing through the priority review and approval procedure. It is used to treat patients with refractory or recurrent acute B-lymphoblastic leukemia who are CD19-positive and need salvage chemotherapy 12 months after the first remission.

65 weipeinatide injection

Holder: Paige Biomedical (Hangzhou) Co., Ltd.

This medicine is suitable for controlling blood sugar in adults with type 2 diabetes.

66 mataxidan injection

Holder: Pfizer Inc

The medicine is suitable for routine preventive treatment of children and adult patients aged 12 years and above who have the following diseases and weigh ≥35kg, so as to prevent bleeding or reduce the frequency of bleeding attacks: severe hemophilia A (congenital coagulation factor V deficiency, FV<1%) without coagulation factor VI inhibitor or severe hemophilia B (congenital coagulation factor X deficiency, FX<1%) without coagulation factor X inhibitor.

67 piconcibimab injection

Holder: Xinda Biomedical Technology (Hangzhou) Co., Ltd.

This medicine is suitable for adult patients with moderate and severe plaque psoriasis who are suitable for systematic treatment.

Sturgeon malate tablets

Holder: Shanghai Shangyao Xinyi Pharmaceutical Co., Ltd.

The medicine is suitable for essential hypertension.

69 zoledretinib tablets:

Holder: Beijing Nuocheng Jianhua Pharmaceutical Technology Co., Ltd.

The drug has been conditionally approved for marketing through the priority review and approval procedure, and is used for adults and adolescents with solid tumors over 12 years old who meet the following conditions: fully verified detection methods are diagnosed as carrying neurotrophic tyrosine receptor kinase (NTRK) fusion gene and do not include patients with known acquired drug resistance mutations, patients with locally advanced and metastatic diseases or surgical resection that may lead to serious complications, and patients who are not satisfied with alternative treatment or have failed in previous treatment.

70 Mapacixavir Capsules

Holder: Healthy Yuan Pharmaceutical Group Co., Ltd.

The drug is suitable for the treatment of previously healthy adolescents and adults with simple influenza A and B, excluding patients with high risk of influenza-related complications.

71 kumoxili capsules

-Holder: Zhida Daqing Yueye Group Co., Ltd.

The drug is suitable for adult patients with locally advanced or metastatic breast cancer who have developed disease after endocrine therapy in the past, and is combined with fulvestrant.

Fentosilan sodium injection

Holder: Genzyme Corporation

The medicine is suitable for routine preventive treatment of children and adult patients aged 12 years and above with the following diseases: severe hemophilia A (congenital coagulation factor VI deficiency, FV<1%) with or without coagulation factor VI inhibitor or severe hemophilia B (congenital coagulation factor X deficiency, FX<1%) with or without coagulation factor X inhibitor.

73 Remibutenib Tablets

Holder: Beijing Novartis Pharmaceutical Co., Ltd.

This drug is suitable for adult patients with chronic spontaneous urticaria who are not adequately controlled by H1 antihistamine.

74 Af Cailletet tablets

Registered person: Cytokinetics, Incorporated

The medicine is used to treat adult patients with obstructive hypertrophic cardiomyopathy (HCM) with new york Heart Association (NYHA) heart function classification I-I, so as to improve exercise ability and symptoms.

Pimitinib Hydrochloride Capsules 75

Registered person: Merck Serono (Beijing) Pharmaceutical Co., Ltd.

The medicine is used to treat adult patients with symptomatic giant cell tumor of tendon sheath (TGCT) whose surgical resection may lead to functional limitation or serious complications.

76 Sotok pull tab

Holder: Baekje Shenzhou (Suzhou) Biotechnology Co., Ltd.

The medicine is suitable for adult patients with chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL) who have received at least one systemic therapy including bruton tyrosine kinase (BTK) inhibitor, and adult patients with recurrent or refractory mantle cell lymphoma (MCL) who have received at least two systemic therapies (including bruton tyrosine kinase (BTK) inhibitor).

Source of Materials: Official WeChat Account of China Pharmaceutical NewsCompilation & Editing: Guangdong Medical Products Administration