51 New Drug INDs Approved in China: From Hepatitis B to Lung Cancer, Innovative and Generic Drugs Advance Together

According to the statistics from the Mosec Pharmaceuticals database, from July 7 to July 13, 2025, a total of 122 innovative drugs / improved new drugs clinical applications / marketing applications were approved by the Center for Drug Evaluation of the National Medical Products Administration.（CDE）Undertake(Statistics by acceptance number, excluding supplementary applications)Among them, there are 95 acceptance numbers for domestically produced drugs and 27 acceptance numbers for imported drugs.

This week, a total of 51 innovative drugs / improved new drugs received "implied permission" for clinical trial applications, including 20 chemical drugs, 29 biological drugs, and 2 traditional Chinese medicine drugs.

A Quick Overview of Innovative Drugs/Modified New Drugs Approved for Clinical Trials This Week (Excluding Supplemental Applications)

Note:Full data can be accessed by scanning the QR code at the "end of the article" for download.

In the global innovative drug research and development field, on July 7,SCG SCIENCE（SCG）Announced, Center for Drug Evaluation, National Medical Products Administration of China（CDE）Approval of its hepatitis B virus（HBV）Specific T-cell Receptor（TCR）Engineered T-Cell Therapy——SCG101VPhase 1/2 Clinical Trial of New Drug（IND）Application for the treatment of chronic hepatitis B. Medical research shows that in healthy adults, it naturally exists in the body through T-cell receptors.（TCR）The mediated specific immune response is the key mechanism for clearing HBV infection. Based on this scientific insight,SCG SCIENCEScreened for high-affinity, high-activity natural TCRs that specifically target hepatitis B surface antigen, and remodeled the patient's immune system through T cell engineering. This led to the development of an innovative cellular therapy pipeline for chronic hepatitis B.SCG101V。

SCG101VMediated by specific TCR, selectively recognizing and targeting HBV-infected hepatocytes, eliminating cccDNA and eradicating viral reservoirs and integrated fragments through multiple mechanisms, while establishing protective immune memory. Once the viral reservoir is completely eliminated, HBV has no pathway to rebound. Clinical data shows,SCG101VDemonstrates "one-shot cure" therapeutic potential: A single administration can simultaneously eradicate hepatitis B cccDNA and hepatitis B surface antigen, with the potential to become a treatment for functional cure of chronic hepatitis B.

Screenshot source: Mose Pharmaceuticals - Global Drug R&D Database

On July 8, the Center for Drug Evaluation of the National Medical Products Administration of China（CDE）Official website announcement,BeiGeneDeclaredTaladotinib for InjectionProposed for Priority Review, with the Indication: For patients who have received at least 2 prior lines of therapy.(Including platinum-based chemotherapy)Failed Extensive-Stage Small Cell Lung Cancer（ES-SCLC）Treatment of adult patients. Public information shows,Taladotinib（tarlatamab）It is a DLL3/CD3 bispecific T-cell engager.（BiTE）。

In May this year,BeiGeneAnnounced its cooperation withAmgen Inc.（Amgen）Jointly conducted in ChinaTaladotinib for InjectionPhase 2 Clinical Study DeLLphi-307 Has Achieved Positive Results. The study aims to evaluateTaladotinibUsed to treat patients who have received at least two prior lines of therapy(Including platinum-based chemotherapy)Efficacy, Safety, and Tolerability in Chinese Patients with Extensive-Stage Small Cell Lung Cancer Who Failed Treatment, with the Primary Endpoint Being Objective Response Rate（ORR）。

In recent years, immunotherapy has achieved breakthroughs in the SCLC field, bringing new options to patients.TaladotinibIs a product byAmgenThe innovative targeted immunotherapy developed by the company can simultaneously bind to the DLL3 protein on tumor cells and the CD3 protein on T cells, thereby activating T cells to kill tumor cells expressing the DLL3 protein.

Top 10 Global Advances in Innovative Drug Development This Week

Screenshot source:MaxEntropy Consulting Weekly Report

Among the TOP10 global clinical results this week, on July 7,I-Mab BiopharmaAnnounced its bispecific antibodygivastomigPositive Data from Phase 1b Combination Therapy Trial.GivastomigIs a Claudin 18.2-targeted（CLDN18.2）Bispecific antibodies targeting Claudin 18.2-positive tumor cells conditionally activate T cells through the 4-1BB signaling pathway in the tumor microenvironment expressing Claudin 18.2.

The drug is manufactured byI-Mab BiopharmaLead andABL Bio CompanyJointly developed, with both parties equally sharing global rights outside of Greater China and South Korea.

Currently,givastomigIt is being developed for the first-line treatment of metastatic gastric cancer and has the potential for further expansion in other solid tumors. As of the data available on May 15, 2025, 17 patients with Claudin 18.2 positive advanced metastatic gastric cancer have received different doses.givastomigUnitednivolumabAndmFOLFOX6As a first-line treatment. The data show that the confirmed ORR was 71% across all dose groups.（12/17）, DCR reached 100%. In the two dose groups selected for dose expansion(8 mg/kg and 12 mg/kg)In China, ORR was 83%（10/12）Notably, responses were observed even in patients with low expression levels of PD-L1 or CLDN18.2. Eight out of 17 patients are still receiving treatment, with the longest treatment duration being 13.3 months as of the data cutoff date. In terms of safety, the combination therapy was well-tolerated, with no nausea or vomiting events of grade 3 or higher, and only one case of a grade 3 treatment-related adverse event.(Elevated liver enzymes)。

Screenshot source: MoEntropy Medicine - Global Drug R&D Database

July 9,Microchip BiotechAnnouncement issued by its independently developedChidamideFor the first-line treatment of diffuse large B-cell lymphoma（DLBCL）Pivotal Phase III Clinical Trial(DEB Study)The topline analysis data of the final results obtained recently shows the event-free survival period in the experimental group.（EFS）Significantly superior to the control group, achieving the primary endpoint of the study.

ChidamideYesMicrochip BiotechThe exclusively discovered new mechanism and new molecular entity drug is the world's first subtype-selective histone deacetylase.（HDAC）Inhibitors, belonging to the class of epigenetic modulators. The DEB study is a randomized, double-blind, placebo-controlled, multi-center confirmatory Phase III clinical trial, aimed at evaluatingChidamideUnitedR-CHOP(Anti-CD20 Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone)ComparisonR-CHOPEfficacy and safety in previously untreated MYC/BCL2 double-expressing DLBCL subjects. Recently, the trial has been completed as the last subject in the study reached the 36-month follow-up period specified by the protocol, and a top-line analysis was conducted. This top-line analysis further confirmed,ChidamideThe combination regimen can bring significant and sustainable event-free survival benefits to previously untreated MYC and BCL2 double-expressing DLBCL patients, with a favorable safety profile.

Top 10 Positive/Failure Clinical Results Worldwide This Week

According to the statistics from the Mosecure Pharmaceuticals database, from July 7 to July 13, 2025, a total of 138 generic drug applications for marketing/clinical trials were accepted by the CDE, including 125 new registration classification marketing application acceptance numbers.(Including chemical drugs Class 3, Class 4, and Class 5.2), 4 clinical application acceptance numbers under the new registration classification(Including Category 3 and Category 4 chemical drugs), 9 applications for consistency evaluation. 4 varieties passed the consistency evaluation this week.(Counted as 4 items by acceptance number)This week, 35 varieties are deemed to have passed the consistency evaluation.(Counted by acceptance number, 40 items)This week, there are 3 regulatory submission updates for biosimilars, respectively.CSPC GroupTheOmalizumab for Injection、CSPC GroupTheLecanemab InjectionandQilu PharmaceuticalTheQL-2106 Injection。

This week's approved/presumed approved varieties mainly includeCardiovascular System Drugs, The main dosage forms of approved/similarly approved products areInjection。

Screenshot source: Mosun Consulting Weekly

This WeekNicardipine Hydrochloride InjectionThe number of accepted applications for multiple varieties that have passed the evaluation / are deemed to have passed the evaluation is as many as 2, simultaneously.Nicardipine Hydrochloride InjectionThe highest number of companies that passed the evaluation/are considered to have passed the evaluation this week is 2.

This week, a total of 37 companies passed the review/were considered to have passed the review, includingZhejiang Yizeda Pharmaceutical Technology Co., Ltd.、Zhejiang Huahai Pharmaceutical Co., Ltd.AndTianjin Lisheng Pharmaceutical Co., Ltd.The company has the highest number of approved/presumed approved varieties, reaching 2.

Varieties that passed the evaluation for the first time this week / Deemed to have passed the evaluation

This Week's Approved/Deemed Approved Enterprises Reach 7 Varieties