▎WuXi AppTec Content Team Report

This week, the field of innovative drug research and development has seen many advancements.. For example:JuventasCAR-T ProductsHUTCHMEDRocheCD20/CD3 Bispecific Antibody Granted Conditional Approval in China on the Same Day, respectivelyB-cell Acute Lymphoblastic Leukemia andA New Treatment Option for Patients with Diffuse Large B-Cell Lymphoma；HUTCHMED and Takeda's Fruquintinib Receives Early FDA Approval in the U.S.; Hengrui Pharma JAK1 inhibitor andTriple-Combination Diabetes Drug Submits Sequential Market Applications；Roche,AstraZeneca/Daiichi SankyoHUTCHMEDKangzhe BiologicsThree New Drugs ApprovedProposed for Priority Reviewetc.。This article will provide a brief introduction to some of the important advancements, for readers' reference only.

———✦New Drug Approval/Filing for Market Launch✦———

China's National Medical Products Administration (NMPA) announced that the marketing application of Juventas' CAR-T product, Naciorlen Injection, has been approved for use.Treatment of Adult Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia (r/r B-ALL)Notably, this is also the first CAR-T product for the treatment of leukemia to be approved for marketing in China. The Naciorlucel Injection (CNCT19 Cell Injection, Inaticabtagene Autoleucel) isA CAR-T cell therapy product targeting CD19, featuring an innovative CD19 scFv (HI19a) structure.

NMPA Official Website Announcement: Genfituzumab Injection (Trade Name: Golorui/Columvi) submitted by Roche has been granted conditional approval for marketing in China. It is used to treat patients who have previously received at least two lines of systemic therapy.Adult patients with relapsed or refractory diffuse large B-cell lymphoma. Public information shows that this isA Bispecific T-Cell Engager Targeting CD20 and CD3, with a unique 2:1 structure, containing two protein domains that can bind to CD20 and one protein domain that can bind to CD3.

HUTCHMED Announces FDA Approval of Fruzaqla (fruquintinib), Co-developed with Takeda, for the Treatment of Adult Patients with Metastatic Colorectal Cancer Who Have Previously Received Fluoropyrimidine-, Oxaliplatin-, and Irinotecan-Based Chemotherapy, Anti-Vascular Endothelial Growth Factor (VEGF) Therapy, and Anti-Epidermal Growth Factor Receptor (EGFR) TherapyColorectal CancerPatients. According to the HUTCHMED press release,Fruquintinib: The First and Only FDA-Approved Highly Selective Inhibitor Targeting All Three VEGF Receptor Kinases for the Treatment of Previously Treated Metastatic Colorectal Cancer, Regardless of Patient Biomarker Status。

The official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration announced that Shengdi Pharmaceuticals, a subsidiary of Hengrui Pharma, has submitted a new drug marketing application for HR20031 tablets, which has been accepted by the CDE. Public information shows that HR20031 tablets are a sodium-glucose co-transporter-2 (SGLT2) inhibitor.Hengrui PharmaDipeptidyl Peptidase-4 (DPP-4) InhibitorsRimeglizineHUTCHMEDMetforminComposed ofFixed-dose combination sustained-release formulation, to be taken orally once daily for the treatment of type 2 diabetes with inadequate glycemic control despite metformin therapy.

Hengrui Pharma announced that the marketing authorization application for its SHR0302 tablet has been accepted by the CDE. The proposed indication is: for patients with inadequate response or intolerance to topical or other systemic treatments.Adults and adolescents aged 12 years and above with moderate to severe atopic dermatitisSHR0302 isA Highly Selective JAK1 Inhibitor, which has previously submitted two marketing applications in China for the treatment ofModerate to Severe Atopic Dermatitis, and those with poor efficacy or intolerance to non-steroidal anti-inflammatory drugs (NSAIDs) treatmentActive Ankylosing SpondylitisAdult patients.

Image Source: 123RF

———✦OthersNew Drug Progress✦———

CDE Official Website Announcement: Roche's Application for Alectinib Hydrochloride Capsules Proposed for Priority Review, with the Proposed Indication as: ForAdjuvant Treatment Post Complete Tumor Resection in Anaplastic Lymphoma Kinase (ALK)-Positive Non-Small Cell Lung Cancer (NSCLC) PatientsNotably, Alectinib for this indication was granted inclusion in the breakthrough therapy category by the CDE last month. Alectinib is a product developed by Roche.Next-Generation ALK Inhibitor. It was previously approved for marketing in China in 2018 for the treatment of ALK-positive locally advanced or metastatic NSCLC.

CDE Official Website Announcement: Daiichi Sankyo's Application for a New Indication of Trastuzumab Deruxtecan for Injection Proposed for Priority Review, as Monotherapy for the Treatment of Locally Advanced or Metastatic Disease Previously Treated with Two or More Prior Lines of TherapyHER2-Positive Adult Gastric or Gastroesophageal Junction AdenocarcinomaPatient. Public information shows that Trastuzumab Deruxtecan (Enhertu) is jointly developed by AstraZeneca and Daiichi Sankyo.An antibody-drug conjugate (ADC) targeting HER2, which has been previously approved in China for the treatment of HER2-positive and HER2-low adult breast cancer patients.

CDE official website announcement, Kangzhe Biologics' applicationUrsodeoxycholic Acid Oral SuspensionTo be included in the priority review for the reason of "new varieties, dosage forms, and specifications of pediatric drugs that meet the physiological characteristics of children," intended for the treatment of: 1)Gallbladder Cholesterol Stones；2）Cholestatic Liver Disease(such as primary biliary cirrhosis); 3)Bile Reflux GastritisUrsodeoxycholic acid has important properties such as bile promotion, liver protection, blood sugar reduction, lipid lowering, and immune regulation. It can reduce cholesterol absorption in the intestines, lower cholesterol content in bile, and decrease cholesterol secretion into bile.

Akeso Biopharma announced that the company has developedPD-1/CTLA-4 Bispecific AntibodyCadonilimab (Kaitanni) met the primary endpoint in an interim analysis of a randomized, double-blind, multicenter Phase 3 study, code-named AK104-302. The trial aims to evaluate cadonilimab in combination with oxaliplatin and capecitabine (XELOX) versus placebo in combination with XELOX asFirst-line treatment for unresectable locally advanced or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma (GC/GEJC)The efficacy and safety. The results showed that the combination therapy significantly prolonged the overall survival (OS) of the entire population (regardless of PD-L1 expression), meeting the pre-set superiority criteria. The Independent Data Monitoring Committee (IDMC) recommended submitting the new drug marketing application for Cadonilimab for this indication ahead of schedule based on the interim analysis results.

Immunotech announced that its researchSIRPαFc Fusion Protein Drug Targeting Human CD47Tidapacip (IMM01) in combination with azacitidine for the treatment of previously untreated chronic myelomonocytic leukemia (CMML) has been granted an indication by the U.S. FDA.Orphan Drug DesignationIMM01 has a dual mechanism, capable of simultaneously blocking the "don't eat me" signals from tumors and activating the "eat me" signals of the patient's immune system through IgG1. Currently, the product has entered Phase 2 clinical development for 9 indications, covering both hematological malignancies and solid tumors.

In addition to the aforementioned new drugs, many other innovative drugs developed by Chinese companies have made progress this week, such as several new drugs being introduced in China for the first time.Approved for Clinical Useetc. Due to space limitations, this article will not introduce them one by one. It is hoped that the subsequent research of these new drugs will proceed smoothly and benefit patients as soon as possible.。

[2] Press releases and announcements from various companies