20 Blockbuster Drugs Expected to Gain Approval in China in 2026

The year 2026 has arrived. According to the "China Market Entry Strategy & Timeline Prediction" module in the Insight database,In the new year,An estimated 94 new drugs(Excluding modified new drugs, similar drugs, and vaccines, statistics as of 2026/1/3)Will be inIn ChinaFirst approved for marketing, covering a wide range of indications in both oncology and non-oncology fields. This article will share information on 20重磅 new drugs that have been granted priority review, for reference only.

Huahui Health: Libevirtamab

Indications: Hepatitis D

Expected Approval Time: Q1 2026

In December 2024, the marketing application for Libevirtamab from Huahui Health was accepted by the CDE. This application has been granted priority review for the treatment ofChronic Delta Hepatitis Virus Infection。

Libivirumab is the world's first targeted hepatitis B virus surface large envelope protein pre-S1.（PreS1）Neutralizing antibodies in the region, alsoThe First Hepatitis D Treatment Drug to Submit an Application for Market Launch in China. The drug has beenKey Registration Clinical Phase IIb Study for the Treatment of Chronic Hepatitis D Virus Infection（HH003-204）Showed excellent efficacy and safety.

GSK: Maveralimab

Indications: Multiple Myeloma

Expected Approval Time: Q1 2026

In December 2024, GSK's Maralixibat submission for marketing authorization was accepted by the CDE and included in the priority review, indicated for use in combination with bortezomib and dexamethasone for the treatment of patients who have previously received at least one therapy.Multiple MyelomaAdult patients.

Belantamab mafodotin is a BCMA ADC developed by GSK, which was first approved for marketing by the FDA and the EU in 2020. However, due to not meeting the primary endpoint in subsequent Phase III trials, GSK withdrew the marketing application for belantamab mafodotin.

Although the first market launch failed, Mabranzumab showed positive results in the subsequent DREAMM-7 study. In October 2025, Mabranzumab was re-approved by the FDA for marketing. The indication is Mabranzumab + Bortezomib + Dexamethasone for the treatment of adult patients with relapsed/refractory multiple myeloma. This is alsoThe World's First Approved BCMA ADC。

Sanofi: Plasilan Sodium

Indications: Familial Hyperchylomicronemia

Expected approval time: Q1 2026

On January 27, 2025, the CDE accepted the marketing application for Pulerastan Sodium for the treatment ofFamilial Chylomicronemia Syndrome（FCS）. The application has been included in the priority review.FDA has approved volanesorsen sodium for marketing as an adjunct to dietary therapy to reduce triglyceride levels in adult patients with FCS.Only requires a subcutaneous injection once every three months.

Pursiran sodium is an RNA interference therapy developed by Arrowhead. The rights to the drug in China were initially held by Viia Biotech, a subsidiary of Arrowhead. In August 2025, Sanofi signed an agreement with Viia Biotech to obtain the development and commercialization rights for pursiran sodium in Greater China.

BeiGene: Sotoclax

Indications: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Expected Approval Time: Q1 2026

April 2025, BeiGeneNew Generation BCL2 InhibitorSotoclax TabletsThe listing application was accepted by the CDE and included in the priority review for the treatment of patients who have previously received treatment.Chronic Lymphocytic Leukemia（CLL）/Small Lymphocytic Lymphoma（SLL）Adult patients.

In May 2025, the second indication application for Sotoclax was also accepted by the CDE and included in the priority review, intended for the treatment of patients who have previously received anti-CD20 therapy and BTKi therapy.Mantle Cell Lymphoma（MCL）Adult patients. In addition, in November 2025, the U.S. FDA officially accepted the marketing application for Sotoclax and granted it priority review status for the treatment of relapsed or refractory MCL in patients who have received BTK inhibitor therapy. This is alsoThe First Chinese-produced BCL2 Inhibitor to File for Market Approval in the U.S.。

Tian Guangshi: MIL62

Indications: Neuromyelitis Optica

Expected Approval Time: Q1 2026

In May 2025, Tian Guangshi's MIL62 injection marketing application was accepted and included in the priority review for the treatment ofNeuromyelitis Optica Spectrum Disorders（NMOSD）。MIL62 Expected to become the first domestically produced drug approved for the treatment of NMOSD in China。

MIL62 is a third-generation anti-CD20 recombinant humanized monoclonal antibody independently developed by Tian Guangshi. In addition to NMOSD, in September 2025, the second indication for MIL62 was accepted by the CDE for the treatment of primary membranous nephropathy.

Lupeng Pharmaceuticals: Lobutinib

Indications: Mantle Cell Lymphoma

Expected Approval Time: Q1 2026

On May 28, 2025, the marketing application for Loprotinib Tablets by Lupeng Pharmaceuticals was accepted for the treatment of adults who have previously received BTK inhibitor therapy.Mantle Cell LymphomaThe application for the patient has been included in the priority review.

Lobutinib isA Fourth-Generation Covalent and Non-Covalent BTK Inhibitor, it can overcome various resistance issues caused by BTK mutations against first, second, and third-generation BTK inhibitors. In the field of oncology, multiple clinical trials of Lobutinib are underway, with indications including mantle cell lymphoma, CLL/SLL, marginal zone lymphoma, and diffuse large B-cell lymphoma, among other types of B-cell lymphomas.

In August 2024, Hansoh reached a strategic cooperation with Lupont Pharmaceuticals, obtaining the rights for the research, registration, production, and commercialization of all non-oncology indications of Lobutinib in China. In terms of non-oncology indications, clinical studies of Lobutinib are currently being conducted for chronic spontaneous urticaria, multiple sclerosis, optic neuritis, and other conditions.

Yantai Biotech: Akleran

Indications: Hepatocellular Carcinoma

Estimated Approval Time: Q2 2026

On March 31, 2025, the marketing application for Equecryl Injection by Yantai Biotechnology was accepted for use inPostoperative Preventive Treatment for Recurrence in High-Risk Populations After Radical Resection of Primary Hepatocellular Carcinoma. According to the Insight database, this drug isChina's First Reported Solid Tumor Cell Therapy。

Ecleris Injection is a personalized autologous cell therapy product. Its main active ingredient is CD3+CD8+ cytotoxic T cells, and it also contains immune cell subsets such as NK cells and helper T cells, demonstrating broad-spectrum anti-tumor properties. Unlike gene-modified therapies like CAR-T, Ecleris Injection is a non-gene-modified product with higher safety.

Huahui Pharmaceutical: Resikiribab

Indications: Generalized Pustular Psoriasis

Estimated Approval Time: Q2 2026

On October 1, 2025, the marketing application for Huahui Health's Risicabtag injection was accepted by the CDE for the treatment ofGeneralized Pustular Psoriasis（GPP）, the application has been included in the priority review. This is alsoThe First China-Produced IL-36R Monoclonal Antibody Submitted for Marketing Approval。

Resikizumab（HB0034）HB0034 is an innovative anti-IL-36R antibody. In March 2025, the pivotal clinical trial of HB0034 for the treatment of acute GPP flares met the primary efficacy endpoint and all secondary efficacy endpoints. Compared with placebo, by the first week after a single intravenous dose of HB0034, skin pustules in patients experiencing GPP flares were significantly cleared, achieving the protocol-defined primary endpoint, while demonstrating a favorable safety profile.

Bayer: BAY 2927088

Indications: Non-Small Cell Lung Cancer

Expected approval time: Q2 2026

On July 23, 2025, Bayer's BAY 2927088 tablet marketing application was accepted. This application has been included in the CDE’s priority review for the treatment ofCarrying HER2（ERBB2）Activating MutationAnd have previously received one systemic therapyAdvanced Non-Small Cell Lung Cancer（NSCLC）Adult patients.

BAY 2927088 （Sevabertinib）An orally reversible tyrosine kinase inhibitor（TKI）, approved for marketing in the United States in November 2025, is used for second-line treatment of HER2-mutant non-squamous NSCLC.

CARsgen Pharma: Surrozen Olarsen

Indications: Gastric Cancer

Expected Approval Time: Q2 2026

On June 26, 2025, the marketing application for Carcino Therapeutics' Surige Olranstat Injection was accepted for the treatment of Claudin18.2-positive patients who have failed at least two prior lines of therapy.Advanced Gastric/Esophagogastric Junction AdenocarcinomaThe patient, this application has been included in the priority review.

Surgeoluce（CT041）It is a Claudin18.2-targeted therapy developed by Carsgen Therapeutics.（CLDN18.2）Autologous CAR-T cell therapy, under development for the treatment of Claudin18.2-positive solid tumors, primarily gastric cancer/esophagogastric junction adenocarcinoma and pancreatic cancer. The drug alsoYesThe World's First CAR-T Cell Therapy Product for Solid Tumors to Report for Marketing。

Vcare Pharma: Anruitini

Indications: Solid Tumors

Estimated Approval Time: Q2 2026

On July 4, 2025, Vcare Pharma's Anruitini Capsule marketing application was accepted by the CDE. The application has been included in the priority review, intended for the treatment of patients meeting the following conditions.Adults and Adolescents (12 years of age and older) with Solid Tumors: Carrying NTRK fusion genes; patients with locally advanced or metastatic disease, or whose surgical resection may lead to severe complications, as well as those without satisfactory alternative treatments or who have failed previous treatments.

Anruitinib is a small-molecule targeted anti-tumor innovative drug, belonging to a new generation of TRK inhibitors, with the potential to address secondary resistance issues caused by first-generation drugs targeting the same site. Current clinical data show that Anruitinib not only demonstrates significant efficacy in treatment-naïve patients but also exhibits remarkable therapeutic advantages in drug-resistant patients and those with refractory brain metastases.

Stone Pharmaceuticals/Kangning Jierui: Aninitumab

Indications: Gastric Cancer

Expected approval time: Q3 2026

On September 12, 2025, the marketing application for Anitumab, co-developed by CSPC and Alphamab Oncology, was accepted. The application has been granted priority review by the CDE for the indication of combination with chemotherapy in patients who have failed at least one systemic treatment.HER2-positive locally advanced, recurrent or metastatic gastric/gastroesophageal junction adenocarcinoma. According to the Insight database, this is alsoThe First China-Produced HER2 Bispecific Antibody Submitted for Marketing Approval。

Anitumab（KN026）KN026 is a HER2 bispecific antibody independently developed by Alphamab Oncology. In August 2021, Jinmantuo Biotechnology, a subsidiary of CSPC Pharmaceutical Group, reached an exclusive licensing agreement worth 1 billion yuan with Alphamab Oncology, obtaining exclusive development and commercialization rights for KN026 in breast cancer and gastric cancer indications in mainland China.

Daiichi Sankyo: Pexidartinib

Indications: Giant Cell Tumor of the Tendon Sheath

Expected approval time: Q3 2026

On January 15, 2025, the marketing application for Pexidartinib by Daiichi Sankyo was accepted for the treatment of patients with severe lesions or functional limitations that cannot be improved by surgery.Symptomatic Tenosynovial Giant Cell Tumor（TGCT）Adult patients. The application has been included in the priority review by the CDE.

Pexidartinib is a small molecule tyrosine kinase inhibitor that can inhibit colony-stimulating factor 1 receptor.（CSF1R）, the overexpression of CSF1R ligand promotes cell proliferation and accumulation in the synovium. In addition, Pexidartinib can also inhibit KIT and FLT3. In August 2019, Pexidartinib was approved for marketing by the FDA and isThe world's first approved drug for the treatment of TGCT。

Ark Biopharmaceutical: AK0901

Indications: ADHD

Expected approval time: Q3 2026

On June 14, 2025, Ark Biopharmaceuticals submitted the Methylphenidate and Dexmethylphenidate Compound Capsules.(Research and Development Code: AK0901)The marketing application has been accepted by the CDE. This application has been granted priority review by the CDE for the treatment ofAttention Deficit Hyperactivity Disorder in Children 6 Years and Older(ADHD, Attention Deficit Hyperactivity Disorder)。

AK0901 Openable Capsule is a capsule containing immediate-release dexmethylphenidate.（d-MPH）And the prodrug dexmethylphenidate（SDX）A compound preparation. In March 2021, the drug was approved for marketing in the United States. In December 2021, Aikang Baifa reached a licensing agreement with Commave Therapeutics worth a total of 105.5 million US dollars, obtaining the development, production, and commercialization rights of AK0901 in Greater China.

Hutchmed: Fruquintinib

Indications: Intrahepatic Cholangiocarcinoma

Estimated Approval Time: Q4 2026

On December 24, 2025, the marketing application for HUTCHMED's drug Fruquintinib was accepted. This application has been granted priority review by the CDE for the treatment of patients who have previously received systemic therapy and exhibit...FGFR2 Fusion or RearrangementAdvanced, metastatic, or unresectableIntrahepatic CholangiocarcinomaAdult patients.

Fanruigelatinib（HMPL-453）It is a novel, highly selective, and potent FGFR 1, 2, and 3 inhibitor. This marketing application is based on data from a single-arm, multicenter, open-label Phase II registrational study conducted in China. The study has met its primary endpoint of ORR and achieved positive results in secondary endpoints, including PFS, DCR, DoR, and OS.

Baili Tianheng: BL-B01D1

Indications: Nasopharyngeal Cancer

Estimated Approval Time: Q4 2026

On November 21, 2025, BL-B01D1, developed by Baili Tianheng, had its marketing application accepted. The application has been granted priority review for use in patients previously treated with PD-1/PD-L1 monoclonal antibodies and who have undergone at least two lines of chemotherapy.(At least one platinum-based regimen)Treatment failure in recurrent or metastaticNasopharyngeal CarcinomaPatient. The drug isThe world's first and currently only bispecific ADC submitted for marketing。

BL-B01D1（iza-bren）Is a globally pioneering EGFRxHER3 bispecific antibody-drug conjugate (ADC). This marketing application is based on the results of the Phase III clinical trial BL-B01D1-303 of BL-B01D1 in nasopharyngeal carcinoma. In July 2025, the interim analysis of this study has reached the primary endpoint, demonstrating that BL-B01D1 significantly improved patients' ORR and PFS compared to chemotherapy. Additionally, the application for izabren in esophageal squamous cell carcinoma has been granted priority review by the CDE.

Novartis: Onasemnogene abeparvovec

Indications: Spinal Muscular Atrophy

Expected Approval Time: Q4 2026

On August 2, 2025, Novartis' Onasemnogene Abeparvovec Intrathecal Injection(OAV101 Injection)The listing application has been accepted. The application has been included in the priority review by the CDE for the treatment of6 months of age and above with 5q spinal muscular atrophy（SMA）Patient.

OAV101 is an adeno-associated virus-based（AAV）Gene therapy drugs with vectors can achieve sustained SMN protein expression through a single intravenous injection, thereby halting disease progression. Previously, this drug has been approved for marketing in the United States, the European Union, and Japan for the treatment of spinal muscular atrophy. In 2024, the global sales of this drug reached 1.214 billion US dollars.

Johnson & Johnson: Nicarlimab

Indications: Myasthenia Gravis

Expected approval time: Q4 2026

On April 23, 2025, the marketing application for Janssen's Nicallimab Injection was accepted. This application has been included in the priority review, applicable for treating patients who are positive for autoantibodies.Generalized Myasthenia Gravis（gMG）Adult and adolescent patients(Over 12 years old)。

Nipocalimab is an FcRn antibody acquired by Johnson & Johnson through the approximately $6.5 billion acquisition of Momenta Pharmaceuticals. It can specifically bind to FcRn, blocking its interaction with IgG antibodies, reducing the recycling and circulation of IgG antibodies, and fundamentally lowering the levels of autoantibodies in the blood. In April 2025, the drug received FDA approval for marketing to treat patients with gMG.

Langlai Technology: MY008211A

Indications: Paroxysmal Nocturnal Hemoglobinuria

Expected approval time: Q4 2026

On October 18, 2025, the marketing application for MY008211A tablets developed by Longlai Technology was accepted for the treatment of patients who have not previously received complement inhibitor therapy.Paroxysmal Nocturnal Hemoglobinuria（PNH）Adult patients. The application has been included in the priority review by the CDE.

MY008211A is a complement B factor independently developed by Langlai Technology.（CFB）Inhibitor. According to the Insight database, currently, there is only one CFB inhibitor approved for marketing both in China and overseas, which is Novartis' Iptacopan. MY008211A from Langla Technology ranks second in this field.The First Chinese-Produced CFB Inhibitor to Report for Marketing。

PharmaChina: Tengotinib

Indications: Biliary Tract Cancer

Estimated Approval Time: Q4 2026

On December 19, 2025, the marketing application for Tienogrel, developed by Pharmaron, was accepted. This application has been granted priority review by the CDE for use in patients with advanced, metastatic, or unresectable conditions who have previously received at least one systemic treatment and FGFR inhibitor therapy.CholangiocarcinomaTreatment of adult patients.

Tinengotinib is an innovative multi-target small molecule kinase inhibitor that exerts anti-tumor effects by targeting tumor cells and improving the tumor microenvironment. Currently, Pharmaron is conducting multiple clinical trials of tinengotinib worldwide, with indications covering various solid tumors such as cholangiocarcinoma, prostate cancer, breast cancer, and liver cancer.

Cover source: ZCOOL HELLOR

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Editor: Er You

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