▎WuXi AppTec Content Team Report

Public data shows that in the just-passed 2023, more than 80 new drugsApproved for the First Time in China, bringing new treatment options for different types of patients. Looking ahead to 2024, which new drugs are expected to be approved for marketing in China and benefit patients? This article will share based on the priority review announcements from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) official website.32 Products*New drugs expected to be approved in China in 2024 are for readers' reference only.（*Note: This article only shares some of the new drugs that have been officially included in the priority review by the CDE, and it is not an exhaustive list. The drugs are sorted by the publication date of the CDE's priority review.）

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Takeda: Injectable susoctocog alfa

Mechanism of Action: Recombinant Antihemophilic Factor

Indications: Acquired Hemophilia A

Susoctocog alfa for injection, developed by Takeda, is a recombinant antihemophilic factor (porcine sequence) and a recombinant DNA-derived antihemophilic factor, which can replace human...Coagulation Factor VIIIPlay an obvious hemostatic role. In June 2022, the product's marketing applicationIncluded in the CDE's priority review, intended for on-demand treatment and control of bleeding episodes in adult patients with acquired hemophilia A.。

Roche: Colibro Monoclonal Antibody Injection

Mechanism of Action: A New Generation of C5 Complement Inhibitors

Indications: Paroxysmal Nocturnal Hemoglobinuria

Colrolimab Injection (crovalimab）YesDeveloped by RocheA New Generation C5 Complement InhibitorIn July 2022, the new drug application for Crovalimab was granted priority review by the CDE, intended for use in adult and adolescent patients with paroxysmal nocturnal hemoglobinuria.

ArkBio: Cytrovi Enteric-Coated Capsules

Mechanism of Action:RSV Fusion Protein Small Molecule Inhibitor

Indications:RSV Infection

Cyrus is developed by ArkBio.ARespiratory Syncytial Virus (RSV)Fusion Protein Small Molecule Inhibitor。2022November,CyrusThe new drug marketing application has been included in the priority review by the CDE., ProposedUsed forTreatment of Respiratory Tract Infections Caused by RSV in Children Aged 2 Years and Below。

Legend Biotech/Johnson & Johnson: Cilta-cel Injection

Mechanism of Action: BCMA-Targeted CAR-T Therapy

Indications: Multiple Myeloma

Cilta-cel (cilta-cel) isJohnson & Johnson'sA CAR-T therapy targeting B-cell maturation antigen (BCMA) co-developed by Johnson & Johnson Innovative Medicine and Legend Biotech. In January 2023, the CDE granted priority review to the product's new drug application for the treatment of patients who have previously received one proteasome inhibitor and one immunomodulatory agent.Adult patients with relapsed or refractory multiple myeloma (R/R MM)。

Takeda: Vonicog alfa for injection

Mechanism of Action: Recombinant Von Willebrand Factor

Indications: Von Willebrand Disease

Vonicog alfa for injection is a recombinant von Willebrand factor developed by Takeda. In January 2023, the marketing application of this product was included in the priority review by the CDE for the indication of:For adult patients diagnosed with von Willebrand disease, including on-demand treatment and control of bleeding events, as well as perioperative bleeding management.

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Zai Lab: Combination Packaging of Injectable Sulbactam Sodium and Injectable Durlobactam Sodium

Mechanism of Action: Anti-infective Combination Preparation

Indications: Acinetobacter baumannii infection

SUL-DUR (Sulbactam Sodium-Durlobactam Sodium) is a new intravenous combination antibiotic drug, developed bySulbactam Sodium (a β-lactam antibiotic for intravenous infusion)AndDurlobactam Sodium (A Novel Broad-Spectrum Intravenous β-Lactamase Inhibitor)Combined. Zai Lab has the exclusive rights to develop and commercialize SUL-DUR in Greater China and several other countries and regions.In January 2023, the CDE included the new drug marketing application for SUL-DUR in the priority review, intended for use inTreatment of infections caused by Acinetobacter baumannii (including multidrug-resistant and carbapenem-resistant [CRAB] strains)。

Huadong Medicine: Rilonacept for Injection (Tentative)

Mechanism of Action:IL-1 Inhibitor 

Indications: Cryopyrin-Associated Periodic Syndromes (CAPS)

Rilonacept for Injection isAIL-1 Inhibitor, Huadong Medicine's wholly-owned subsidiary Zhongmei HuadongOwnThe ProductAn exclusive license in 24 Asia-Pacific countries and regions, including China, South Korea, Australia, New Zealand, and India (excluding Japan), encompassing development, registration, and commercialization rights.In January 2023, the product's marketing application was included in the priority review by the CDE, intended for use inTreatment of CAPS in adults and adolescents aged 12 years and above, including Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome.

Eisai/Biogen: Leqembi Injection

Mechanism of Action: Anti-Amyloid Fibril Antibody

Indications: Alzheimer's Disease

Lecanemab is an anti-amyloid-beta (Aβ) protofibril antibody, itsGlobal Development and Regulatory Submissions by Eisai（Eisai）Led by, while the product is co-commercialized and promoted by Eisai and Biogen.In February 2023, the new drug application for this product was granted priority review by the CDE.The proposed indication is for early stage.Alzheimer's Disease (AD)That is, AD-derived mild cognitive impairment (MCI) and mild AD dementia with confirmed amyloid pathology.

Bristol-Myers Squibb: Mavacamten

Mechanism of Action: Cardiac Myosin Inhibitor

Indications: Obstructive Hypertrophic Cardiomyopathy

Mava凯泰 is an innovative oral selective cardiac myosin allosteric modulator developed by Bristol-Myers Squibb, targeting the underlying pathophysiology of symptomatic obstructive hypertrophic cardiomyopathy (oHCM). In February 2023, the new drug application for this product was granted priority review by the CDE.Intended for the treatment of symptomatic oHCM adult patients。

Takeda/Otsuka Pharmaceutical: Ponatinib Tablets

Mechanism of Action: Bcr-Abl Inhibitor

Indications: Chronic Myeloid Leukemia, Leukemia, etc.

Ponatinib Tablets (ponatinib) is a third-generation Bcr-Abl kinase inhibitor, developed byCo-developed by Otsuka and TakedaIn April 2023, the listing application for Ponatinib Tablets was included in the priority review by the CDE. The proposed indications include: 1)For previous medications that are either drug-resistant or intolerantChronic Myeloid Leukemia (CML)；2）Recurrent or RefractoryPhiladelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ALL)；3）T315I-positive CML or T315I-positive Ph+ ALL。

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Bebetter Pharmaceuticals: Disulfiram Injection

Mechanism of Action: PI3K/HDAC Dual-Target Anticancer Drug

Indications: Diffuse Large B-Cell Lymphoma

Bilibast is a product developed by Bebetter Pharmaceuticals.PI3K/HDAC Dual-Target AnticancerNew Drug. In July 2023, the marketing application for the injectable drug Bispecific Antibody was included in the priority review by the CDE, intended for use inTreatmentHaving received at least two prior systemic treatmentsAdult patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL)。

Huadong Medicine/ImmunoGen: Mirvetuximab

Mechanism of Action: FRα-Targeted ADC

Indications: Epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer

Somiromab is an innovative ADC targeting the FRα developed by Sinomedit, a wholly-owned subsidiary of Huadong Medicine, in collaboration with ImmunoGen. Sinomedit holds the exclusive rights for clinical development and commercialization of this product in Greater China. In July 2023, the marketing application for Somiromab Injection was granted priority review by the CDE, intended for the treatment of patients who have previously received 1-3 lines of systemic therapy.Adult patients with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer。

Johnson & Johnson: Telitacicept Injection

Mechanism of Action: BCMA/CD3 Bispecific Antibody

Indications: Multiple Myeloma

Teclistamab, developed by Johnson & Johnson's innovative pharmaceutical division, is a bispecific antibody therapy targeting BCMA and CD3. In August 2023, the CDE included the marketing application for teclistamab injection in the priority review, with the proposed indication being: monotherapy for patients who have previously received at least three types of treatment (including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody).Adult patients with relapsed or refractory multiple myeloma。

Dizhe Pharmaceuticals: Goliditini

Mechanism of Action: JAK1 Inhibitor

Indications: Peripheral T-cell Lymphoma

Golidixtinib is a new-generation oral, highly selective JAK1 inhibitor developed by Dizhe Pharmaceuticals. It has potential efficacy in treating various hematological tumors, solid tumors, and autoimmune diseases. In August 2023, the CDE included the marketing application of Golidixtinib capsules in the priority review, targeting the indications for:Adult patients with r/r PTCL who have received at least one prior standard treatment。

Akeso Biologics: Ewoxi Monoclonal Antibody

Mechanism of Action: PD-1/VEGF Bispecific Antibody

Indications: Non-Small Cell Lung Cancer

Ivonescimab (AK112/SMT112) is a PD-1/VEGF bispecific antibody developed by Akeso Biopharma. In August 2023, the new drug application for ivonescimab was granted priority review by the CDE, for the indication of: in combination with pemetrexed and carboplatin for patients who have progressed after treatment with EGFR tyrosine kinase inhibitors (EGFR-TKIs).EGFRTreatment of Locally Advanced or Metastatic Non-Squamous NSCLC with Mutations。

Novo Nordisk: Recombinant Factor VIII (Pegylated)

Mechanism of Action: Long-acting Recombinant Factor VIII

Indications: Hemophilia A in adults and children

Turoctocog alfa pegol for injection is a product developed by Novo Nordisk.Long-acting Recombinant Factor VIII (FVIII), After being modified with polyethylene glycol (PEG), its half-life has been significantly extended. In September 2023, the CDE included the product's marketing application in the priority review, intended for use in adult and pediatric patients with Hemophilia A (congenital Factor VIII deficiency).

Yuan Yi Biotech: Ganaxolone Oral Suspension

Mechanism of Action: GABAA Receptor-Targeting Positive Allosteric Modulator

Indications: Epilepsy

GanaxoloneOral Suspension(Ganaxolone) is a product developed by Marinus.Positive allosteric modulators targeting GABAA receptors,Yuan Yi Biotech has exclusive rights to develop and commercialize the drug in Greater China. In September 2023, the product's new drug application was granted priority review by the CDE.ProposedFor the treatment of seizures in patients aged 2 years and older with cyclin-dependent kinase 5 (CDKL5) deficiency disorder (CDD)。

R-Code Pharmaceuticals: Osimertinib Phosphate Film-Coated Tablets

Mechanism of Action: Oral Cortisol Synthesis Inhibitor

Indications: Endogenous Hypercortisolism

Osilodrostat Phosphate Film-Coated Tablets (LCI699) is a novel oral cortisol synthesis inhibitor. In 2019, Recordati acquired the global development and commercialization rights of Osilodrostat Phosphate Film-Coated Tablets from Novartis. In October 2023, the Osilodrostat Phosphate Film-Coated Tablets submitted by Recordati Group's wholly-owned subsidiary in China, Rongkangdi Pharmaceuticals, were granted priority review by the CDE.Intended for the treatment of adult endogenous Cushing's syndrome (also known as: endogenous hypercortisolism)。

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Innovent Biologics/GengFang Pharmaceuticals: Fuzelase Tablets

Mechanism of Action: KRAS G12C Inhibitor

Indications: Non-Small Cell Lung Cancer

Fuzelase Tablets are a highly effective oral new molecular entity compound, and alsoChina's First KRAS G12C Inhibitor to Submit an Application for Market LaunchInnovent Biologics has reached an exclusive global licensing agreement with Jemincare Pharmaceuticals, obtaining exclusive rights to develop and commercialize the product in China as the exclusive partner. In October 2023, the marketing application for Fuzelase Tablets was granted priority review by the CDE for the treatment of patients who have received at least one systemic therapy.KRAS G12CMutant-type advanced non-small cell lung cancer。

Lilly: Pirtobrutinib Tablets

Mechanism of Action: BTK Inhibitor

Indications: Mantle Cell Lymphoma

Pirtobrutinib Tablets (pirtobrutinib) are developed by Eli Lilly.（Eli Lilly and Company）A non-covalent, highly selective BTK inhibitor under development. In October 2023, the product's marketing application was granted priority review by the CDE, with the proposed indication being: patients who have previously received BTK inhibitor treatment.Relapsed or Refractory Mantle Cell Lymphoma (MCL)Adult patients.

Connoymab: Sipuleucel-T Injection

Mechanism of Action: IL-4Rα Monoclonal Antibody

Indications: Atopic Dermatitis

Sipuleucel is a targetedInterleukin-4 Receptor Alpha Subunit（IL-4Rα) is a highly efficient, humanized monoclonal antibody. In November 2023, the marketing application of this product was included in the priority review by the CDE, intended for development to treat conditions that are not well-controlled by topical medications or unsuitable for such treatments.Adult Moderate to Severe Atopic Dermatitis。

Tainuomab: TNM002 Injection

Mechanism of Action: Recombinant Natural Fully Human Monoclonal Antibody Against Tetanus Toxin

Indications: Tetanus

TNM002 Injection is developed by Tanomab.Recombinant Anti-Tetanus Toxin Natural Fully Human Monoclonal Antibody DrugIn November 2023, the marketing application of TNM002 was included in the priority review by the CDE, intended for use inEmergency Prevention of Tetanus in Adults。

Lilly: donanemab

Mechanism of Action: β-Amyloid Antibody

Indications: Early Alzheimer's Disease

Donanemab is a monoclonal antibody developed by Eli Lilly that binds to the N3pG subtype of beta-amyloid protein. It can bind to beta-amyloid protein in amyloid plaques in the brains of Alzheimer's disease patients, thereby promoting the clearance of amyloid deposits in the patient’s brain. In November 2023, the new drug application for donanemab injection was granted priority review by the CDE.Intended for the treatment of early Alzheimer's disease。

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Kelon Botai: Injectable SKB264

Mechanism of Action: TROP2-ADC

Indications: Triple-negative Breast Cancer

SKB264 is a product developed by Kelun-Biotech.Innovative Antibody-Drug Conjugate (ADC) Targeting TROP2. In November 2023, the product's marketing application was included in the priority review by the CDE, intended for use in patients with unresectable locally advanced or metastatic disease who have previously received at least two systemic treatments (at least one of which was for advanced or metastatic stage).Adult Patients with Triple-Negative Breast Cancer。

AnHeart Therapeutics/Innovent Biologics: Taletrectinib Capsules

Mechanism of Action: ROS1 Tyrosine Kinase Inhibitor

Indications: Non-Small Cell Lung Cancer

Talazoparib Capsules (taletrectinib) isANovel Next-Generation ROS1 Tyrosine Kinase Inhibitor, by Baoyuan Pharmaceuticals and Innovent BiologicsCo-develop and commercialize in ChinaIn November 2023, the CDE included the marketing application for Taletrectinib capsules in the priority review, intended for use in patients who have failed ROS1-TKI treatment.ROS1-Positive Locally Advanced or Metastatic Non-Small Cell Lung CancerTreatment of Adult Patients.

Roche: Motobuzumab Injection

Mechanism of Action: CD20/CD3 T Cell Engager Bispecific Antibody

Indications: Follicular Lymphoma

Mosunetuzumab Injection is a CD20/CD3 T-cell engaging bispecific antibody developed by Roche.Represents a chemotherapy-free, off-the-shelf new immunotherapy option. November 2023,The product's marketing application was submitted to the CDEIncluded in the priority review, applicable for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have previously received at least two systemic therapies.

In addition to the aforementioned drugs, many other new drugs are also expected to be approved in China in 2024. Due to space limitations, this article will not introduce them one by one. Hopefully, these new drugs will soon reach patients, providing them with new treatment options!

2023 has come to an end, and we have conducted an in-depth review of the new drugs approved for marketing in China in 2023. Scan the QR code below, and youWill receive the content organized by the WuXi AppTec team"New Drugs Approved for Marketing in China in 2023" PDF File。

References:

[1] Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China. from https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d

[2] Official press releases from various companies