China's Healthcare Reforms Advance with DRG/DIP 2.0; Multiple Biotechs Including Innovent, Taurine Biosciences, and Suzhong Pharma Report Key Regulatory and Clinical Milestones

丨New Edition of DRG/DIP Scheme Released

On July 23, the National Healthcare Security Administration released the 2.0 version of the grouping plan for payment by diagnosis-related groups (DRG) and diagnosis-intervention packets (DIP). It was clarified that starting from 2025, all coordinated regions in China will uniformly adopt this grouping version. Based on national consistency, each region can adjust local subgroups and disease categories according to actual conditions. In the past, diagnoses, examinations, and treatments during a patient's hospital stay were charged per item. After the DRG/DIP reform, payments will be made based on disease groups or categories—payment by disease group is called DRG, and payment by disease category is called DIP. Under these two payment methods, regardless of how many drugs or consumables are used during treatment, there are predetermined payment standards.

The adjusted version 2.0 of the DRG grouping includes 409 core groups (an increase of 33 groups compared to before) and 634 subgroups (an increase of 6 groups compared to before). Key adjustments were made to 13 disciplines with concentrated clinical opinions, refining the groupings with higher resource consumption. The version 2.0 DIP grouping includes 9,520 core diseases, covering more than 95% of discharge cases. (China Health Insurance)

丨Innostellar Biotherapeutics' Gene Therapy Class 1 New Drug Proposed for Inclusion in Breakthrough Treatment Category

On July 22, the official website of the Center for Drug Evaluation (CDE) under the China National Medical Products Administration (NMPA) announced that LX101 Injection, submitted by Shanghai Langsheng Biotechnology (a subsidiary of Innostellar Biotherapeutics), has been proposed for inclusion in the breakthrough therapy designation. It is intended for treating patients with inherited retinal dystrophy (IRD) associated with biallelic RPE65 mutations. Public information indicates that LX101 Injection is a gene therapy drug using rAAV as a vector, and its treatment for RPE65 mutation-related IRD has entered phase 3 clinical trials. LX101 is a gene therapy drug developed by Shanghai Langsheng Biotechnology for hereditary retinal degeneration. The drug uses adeno-associated virus serotype 2 (AAV2) to carry the normal RPE65 gene, which specifically identifies and transfects diseased retinal pigment epithelial cells. It enables sustained and efficient expression of the RPE65 protein, which is deficient in patients, restoring normal visual cycles and achieving the therapeutic goal of improving visual function. (Innostellar Biotherapeutics)

丨Innovent Bio: Filing for Market Approval of Mazdutide's Diabetes Indication Imminent

On July 22, Innovent Bio announced that its Glucagon-like Peptide-1 Receptor (GLP-1R)/Glucagon Receptor (GCGR) dual agonist, Mazdutide (research code: IBI362), achieved the primary endpoint and all key secondary endpoints in the Phase 3 clinical study (DREAMS-1) conducted among Chinese subjects with type 2 diabetes. It demonstrated comprehensive benefits in glycemic control, weight reduction, and cardiovascular-renal metabolic indicators. Previously, the Phase 3 clinical trial DREAMS-2 of Mazdutide for treating type 2 diabetes also met its endpoints, showing significantly superior glycemic control compared to the control drug, along with greater comprehensive benefits in weight loss and cardiovascular metabolic indicators. Innovent Bio stated that it plans to submit a New Drug Application (NDA) to the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) for Mazdutide as a treatment for type 2 diabetes in the near future. The marketing application for Mazdutide’s weight management indication was accepted by the CDE earlier in 2024. (Innovent Bio)

丨Guangdong Xiangxue Precision Medicine Technology Co., Ltd. TAEST16001 Injection Proposed for Inclusion in Breakthrough Therapy

On July 22, the latest announcement on the CDE official website revealed that the TAEST16001 injection, submitted by Guangdong Xiangxue Precision Medicine Technology Co., Ltd., is proposed to be included in the breakthrough therapy designation. It is intended for the treatment of soft tissue sarcoma with a tissue genotype of HLA-A*02:01 and positive expression of the NY-ESO-1 tumor antigen. Public information indicates that this is a TCR-T cell immunotherapy product. The TAEST16001 injection was developed by Xiangxue Life Sciences and is an affinity-enhanced TCR-T cell immunotherapy product targeting NY-ESO-1. The first indication for which clinical research was conducted is advanced soft tissue sarcoma that is HLA-A*02:01 positive and expresses the NY-ESO-1 antigen. In 2024, the interim summary data from the Phase 2 clinical trial of TAEST16001 for advanced soft tissue sarcoma was once again selected for presentation at the ASCO Annual Meeting. Early data from the Phase 2 clinical trial demonstrated safety and tolerability consistent with previous Phase 1 studies. (Xiangxue Life Sciences)

丨Tongyuan Kang Medicine Passes HKEX Hearing

On July 22, the Hong Kong Stock Exchange website announced that Tongyuan Kang Medicine's IPO application has passed the hearing. Tongyuan Kang Medicine is committed to discovering, acquiring, developing differentiated targeted therapies and commercializing them to meet unmet medical needs in cancer treatment, especially in the field of lung cancer. Since its establishment in 2017, Tongyuan Kang Medicine has built a pipeline consisting of 11 candidate drugs, including the core product TY-9591 (third-generation EGFR-TKI) at the pivotal Phase 3 clinical stage, six other products in clinical stages, and four preclinical stage products. The company also plans to build sales and marketing capabilities through internal efforts and cooperation with external partners to ensure the successful commercialization of its products in China. (Tongyuan Kang Medicine)

丨Bicycle Therapeutics' Bicyclic Peptide Conjugate Drug Submitted for Clinical Trial in China

On July 23, the latest announcement on the CDE official website revealed that Bicycle Therapeutics' bicyclic peptide conjugate toxin anticancer drug BT8009 has been submitted for clinical trials in China. This is reportedly the first time the drug has been submitted for clinical trials in China. BT8009 is a second-generation bicyclic peptide conjugate toxin therapy under development by Bicycle Therapeutics, targeting Nectin-4. The company's bicyclic peptide technology has previously secured significant collaborations with Roche, Bayer, and Novartis. (CDE)

丨Chipscreen Biosciences' Tucidinostat Triple Combination Therapy Phase 3 Clinical Trial Application Approved by NMPA

On July 23, Chipscreen Biosciences announced that the NMPA has approved the Phase 3 clinical trial application for its Class 1 anti-tumor new drug, Tucidinostat (Chidamide), in combination with Sintilimab and Bevacizumab for the treatment of colorectal cancer. This trial is a randomized, open-label, controlled, multicenter clinical study designed to evaluate the efficacy and safety of Tucidinostat combined with Sintilimab and Bevacizumab in patients with advanced microsatellite-stable or mismatch repair-proficient (MSS/pMMR) colorectal cancer who have failed ≥2 lines of standard therapy. Results from a prior Phase 2 clinical study showed that for patients with metastatic colorectal cancer (mCRC) characterized by microsatellite stability/mismatch repair proficiency (MSS/pMMR), using the triple-drug regimen of Tucidinostat + Sintilimab + Bevacizumab as third-line or later treatment resulted in an 18-week PFS rate of 64.0%, an ORR of 44.0%, and a median PFS of 7.3 months. (Chipscreen Biosciences)

丨Hansoh Pharma's Class 1 Innovative Drug Approved for Clinical Trials

On July 23, the CDE website announced that two clinical trial applications for HS-10380, a Class 1 new drug developed by Hansoh Pharma/Hansoh Pharmaceutical, have been approved. The drug is intended to treat manic episodes in Bipolar I Disorder. Manic episodes in Bipolar I Disorder are one of the manifestations of bipolar disorder (also known as manic-depressive illness). HS-10380 is a multi-target agonist currently under clinical investigation for schizophrenia. HS-10380 is one of Hansoh Pharmaceutical's self-developed projects in the field of neurological disorders. Public data indicates that HS-10380 is a multi-target partial agonist of D2, D3, and 5-HT1A receptors, with significant antagonistic effects on the 5-HT2A receptor, which may help alleviate symptoms in patients with psychiatric disorders. Preclinical studies found that HS-10380 demonstrated superior competitive binding ability to 5-HT1A and 5-HT2A receptors compared to similar control drugs, while also showing higher plasma exposure and exhibiting good efficacy in animal models. (Hansoh Pharmaceutical)

丨CAR-T Cell Therapy IND Application for Icaritin Injection from Reindeer Bio Granted FDA's Tacit Approval

On July 24, IASO Biotherapeutics announced that the Investigational New Drug (IND) application for its self-developed fully human BCMA-targeted chimeric antigen receptor autologous T-cell injection (Equecabtagene Autoleucel Injection) has received tacit approval from the U.S. Food and Drug Administration (FDA) for the proposed treatment of multiple sclerosis. IASO Biotherapeutics stated that this is the second autoimmune disease indication for Equecabtagene Autoleucel Injection to successfully gain FDA approval in 2024, following refractory generalized myasthenia gravis (gMG). It is reported that IASO Biotherapeutics currently has more than 10 innovative drug candidates at various stages of development. Among them, Equecabtagene Autoleucel Injection has been approved for marketing by the National Medical Products Administration (NMPA) and has also received FDA approval for registration clinical trials for the treatment of relapsed/refractory multiple myeloma. (Shanghai Securities News)

丨Taolue Bio and Su Zhong Pharmaceutical Jointly Develop Small Molecule Lung Cancer Drug Proposed for Inclusion in Breakthrough Therapy Category

On July 24, the CDE website announced that the Maleate Sutetinib Capsules, jointly submitted by Jiangsu Suzhong Pharmaceutical and others, are proposed to be included in the breakthrough therapy category. The drug targets locally advanced or metastatic non-small cell lung cancer (limited to non-resistant rare EGFR mutations, including L861Q, G719X and/or S768I). Public information shows that Sutetinib, developed by Taolue Biotechnology (in collaboration with Suzhong Pharmaceutical for R&D in China), is a small molecule inhibitor targeting non-classical EGFR mutations. It is mainly intended for treating locally advanced or metastatic non-small cell lung cancer carrying non-resistant non-classical EGFR mutations (L861Q, G719X, S768I) or other non-resistant non-classical EGFR mutations (E709A, E709K, R776H, G724S, G779F, etc.), or non-classical EGFR mutations resistant to third-generation EGFR inhibitors after first-line treatment. (Taolue Biotechnology, Suzhong Pharmaceutical)

丨AbbVie's Innovative ADC Submits Clinical Application in China

On July 25, the CDE website announced that the clinical trial application for ABBV-706 lyophilized powder for injection submitted by AbbVie had been accepted. Public information indicates that ABBV-706 is an antibody-drug conjugate (ADC) targeting SEZ6, with a payload of TOP1i, and is currently in Phase 1 clinical research internationally. This marks the first clinical trial application in China for this SEZ6-targeting ADC candidate. ABBV-706 utilizes AbbVie's proprietary novel topoisomerase 1 inhibitor (Top1i) payload. Top1i is an anticancer agent that induces cell death by blocking DNA replication. Among 48 evaluable patients (23 with SCLC and 25 with NEN), the overall confirmed ORR was 43.8%. In the SCLC group, the confirmed ORR was 60.9%. As of the data cutoff, among all 53 enrolled patients, the most common ≥ Grade 3 TEAEs were neutropenia (42%), anemia (42%), and leukopenia (28%). (AbbVie)

丨Dren Bio Announces Strategic Collaboration with Novartis

On July 25, Dren Bio announced a strategic collaboration with Novartis. The collaboration will focus on leveraging Dren Bio’s proprietary Targeted Myeloid Engager and Phagocytosis Platform to discover and develop bispecific antibodies for cancer treatment. Under the terms of the agreement, Dren Bio will receive an upfront payment totaling $150 million from Novartis, which includes a $25 million equity investment in the company. Additionally, Dren Bio is eligible to receive up to $2.85 billion in additional milestone payments. Dren Bio and Novartis will collaborate to advance the Targeted Myeloid Engager program in oncology through the selection of a clinical candidate, after which Novartis will assume full responsibility for the remaining development, manufacturing, regulatory, and commercialization activities. (Dren Bio)

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