Three Hepatitis B 'Curative' Drugs, Two Personalized Cancer Vaccines, and a PD-L1/VEGF Bispecific Antibody Drive 138% Stock Surge — CDE Weekly Update

According to the Center for Drug Evaluation of the National Medical Products Administration of China（CDE）According to incomplete statistics from the official website and publicly available information, last week(June 30 - July 7)，Approximately 34 innovative drugs are proposed to be included in the breakthrough therapy category/IND has been granted clinical tacit approval/IND application has been accepted, covering ADC, PD-L1/VEGF bispecific antibody, CAR-T, TCR-T, MSC, and small nucleic acid. Indications focus on solid tumors and also cover chronic hepatitis B, etc.

Hepatitis B virus is widely recognized as the "main culprit" behind liver cancer and decompensated liver function. Long-term infection can lead to a fatal progression: chronic hepatitis → cirrhosis → liver cancer/liver failure. Current treatment options fall short of the internationally acknowledged "functional cure" outlined in guidelines.(Clearance of hepatitis B surface antigen and sustained undetectable viral DNA)The gap remains significant. This week, there are3Hepa Thera's HBV Therapy Receives IND Progress Update.

SCG SCIENCE （DALIAN）CO.,LTD: Single Dose Administration, HBsAg Negative Conversion in 28 Days

SCG101-V Autologous T Cell Injection Approved for Clinical Trials, Aims to Treat Chronic Hepatitis B. According to the company's press release, SCG101V isThe World's FirstTCR-T for Chronic Hepatitis B Approved for Clinical Use, Mediated by Specific TCR, Selectively Identifying and Targeting HBV Infection（HBV）Hepatocytes, through multiple mechanisms, fromFundamentallyClearing Pathogenic Covalently Closed Circular DNA（cccDNA）, and establish protective immune memory, with hopeSingle-dose administration achieves HBV cure。

According to the official press release, data presented at the 2025 European Association for the Study of the Liver (EASL) Annual Meeting showed that, following a single infusion of SCG101, up to94%The patients showed a reduction of 1.0-4.6 log10 within 28 days, and during the follow-up period of up to one year, their HBsAg levels remained consistently below 100 IU/mL without rebound. Among them, 23.5% of the patients, after receiving treatment, 21 DaysAchieve withinHBsAg Completely cleared, and for up to1Remained clear throughout the follow-up period of   years.

Hepa Thera: Just 2 Injections, HBsAg Turns Negative

Hepa Thera's HT-101 Injection Proposed for Inclusion in Breakthrough Therapy Designation for the Treatment of Chronic Hepatitis B Virus Infection. According to public information, HT-101 isThe FirstA domestically produced anti-hepatitis B siRNA new drug that has entered the clinical stage, conjugated with GalNAc, exerts its therapeutic effect by interfering with HBV mRNA, disrupting its function as a post-transcriptional translation template, and preventing the synthesis of related viral proteins, thereby inhibiting the formation of hepatitis B virus particles.

Phase 1b clinical study presented at the 2024 EASL Annual Meeting showed that all participants in the HT-101 treatment group who entered the extension phase maintained a good reduction in HBsAg levels at 48 weeks. Notably, in the 400 mg dose group, one participant achieved this after receiving two doses.48 WeeksFollow-up to achieve HBsAg clearance.

Bowang Pharmaceutical: 56% of Patients Achieve Hepatitis B Surface Antigen Clearance

Bowang Pharmaceutical's BW-20507 Approved for Clinical Trials, Intended for Development in Chronic Hepatitis B Virus Infection. BW-20507 is an siRNA targeting the S region of HBV messenger RNA and has been designated as a breakthrough therapy by the CDE for the treatment of chronic hepatitis B. Phase 1/2a clinical trial results presented at the 2025 European Association for the Study of the Liver (EASL) Annual Meeting showed that BW-20507 was administered via subcutaneous injection., once every four weeks, for a total of three doses, which can significantly reduce HBsAg levels in a dose-dependent manner, with the maximum reduction of 2.9~3.2 log₁₀ IU/mL observed in the 200 mg and 400 mg dose groups.

Kelon Botai: PTK7-Targeted ADC with Leading Progress

Kelun-Biotech's SKB518 Approved for Clinical Trials, Intended for Combination with Tislelizumab With or Without Chemotherapy for Lung Cancer Treatment. According to publicly available data, SKB518 was developed based on Kelun-Biotech's next-generation ADC technology platform OptiDC and targets Protein Tyrosine Kinase 7.(PTK7)PTK7 is expressed at low levels in epithelial, endothelial, and hematopoietic tissues but shows significantly elevated mRNA levels in colon cancer, gastric cancer, lung cancer, and acute myeloid leukemia. Currently, SKB518 has entered clinical trials targeting lung cancer.2Phase Clinical Study, or forGlobal FirstThe first PTK7-targeted ADC to enter Phase II clinical trials.

BioNTech/Prometheus: The $11.1 Billion PD-L1/VEGF Bispecific Antibody Deal

BioNTech/PrimeVax PM8002 Injection Approved for Clinical Trials, Intended to Be Used in Combination with DB-1311 Injection for the Treatment of Advanced/Metastatic Solid Tumors. PM8002 is a PD-L1/VEGF bispecific antibody originally developed by PrimeVax, later acquired by BioNTech, and subsequently sold to BMS.(Potential total amount up to 11.1 billion US dollars)Previously, the phase 2 clinical data of PM8002 combined with chemotherapy for first-line treatment of extensive-stage SCLC showed that at a median follow-up of 14.5 months, the DCR of patients reached 97.9%, ORR reached 85.4%。

Sino Biologics: Holding PD-1/VEGF, Stock Price Surges 138%

SCTB14 is a bispecific antibody injection independently developed by Sinocelltech with the goal of differentiated competitive advantages for immunotherapy of multiple solid tumors, targeting PD-L1/VEGF. According to the Drug Clinical Trial Registration and Information Disclosure Platform, SCTB14 is aimed at non-small cell lung cancer.2/3 Phase clinical trials have been initiated. SCTB14 demonstrated better anti-tumor efficacy than PD-1 and VEGF monoclonal antibodies alone in tumor models with low and medium-high PD-L1 expression; it also showed superior anti-tumor efficacy over ivonesimab and pembrolizumab combined with VEGF monoclonal antibody in tumor models with low PD-L1 expression; induced more tumor-infiltrating T lymphocytes.（TILs）, especially the level of cytotoxic CD8+T lymphocytes, exerting a stronger anti-tumor effect.

On July 4, according to a report by Bloomberg, AstraZeneca is in talks with Summit Therapeutics regarding a potential deal worth up to $15 billion to acquire Akeso's self-developed PD-1/VEGF bispecific antibody. Following this news, the share price of Sinocelltech surged 16.46% to close at RMB 85.41 per share. Since May 14, the company’s cumulative stock price increase has reached138%。

Hansoh Pharma: GSK Invests $1.71 Billion in ADC

Hansoh Pharma's Injectable HS-20093 Approved for Clinical Trials, to Be Combined with Adebrelimab for Patients with Extensive-Stage Small Cell Lung CancerFirst-line maintenance therapyHS-20093 is a B7-H3-targeted ADC composed of a fully human anti-B7-H3 monoclonal antibody and a topoisomerase inhibitor.（TOPOi）The payload is covalently linked and is currently undergoing multiple clinical studies in China for the treatment of lung cancer, sarcoma, head and neck cancer, and other solid tumors, with the highest stage of research being clinical.3Period. In 2023, GSK invested $1.71 billion to acquire the development rights outside of Greater China.

Zhi Xiang Jin Tai: BCMA/CD3 Targeting TCE Goes Global for $712 Million

Zhi Xiang Jin Tai GR1803 Injection Approved for Clinical Trials, Intended to be Combined with Anti-CD38 Monoclonal Antibody for the Treatment of Adult Patients with Relapsed/Refractory Multiple Myeloma. GR1803 is a bispecific antibody TCE that can simultaneously bind to BCMA and CD3 antigens, thereby directing cytotoxic T cells to BCMA-expressing cells. In June this year, GR1803 went overseas and reached a licensing agreement worth up to $712 million with Cullinan.

Lepu Biotech: WT1/CD3/4-1BB Targeting Trispecific TCE

Lepu Biologics' CTM012 Injection Approved for Clinical Trials to Treat Advanced Solid Tumors. According to public information, CTM012 Injection is a novel trispecific TCE that recognizes WT1 under the HLA-A02 background and can dual-activate T cells through CD3 and 4-1BB signaling, thereby producing anti-tumor effects. WT1 can be degraded by proteasomes, processed, and presented as a major histocompatibility complex (MHC) class I epitope on the cell surface to be recognized by T-cell receptors.

Zhongsheng Kangyuan: DC Vaccine

According to publicly available online information, the personalized dendritic cell injection is a novel therapeutic cancer vaccine independently developed by Zhongsheng Kangyuan.The First in ChinaEntering the registered clinical research stageLoaded with multiple tumor neoantigen peptidesTherapeutic tumor DC cell injection. In December 2024, the vaccine targetsHigh-Grade GliomaPhase 1 Clinical Trial Subject Enrollment Has Commenced.

In terms of mechanism, it involves the ex vivo induction and differentiation of the patient’s autologous DC cells, which phagocytose and present tumor neoantigen peptides unique to the patient’s tumor cells. These are then formulated into a high-purity, high-activity DC cell preparation. This preparation is administered via local subcutaneous injection into cancer patients, activating and expanding tumor antigen-specific T lymphocytes within the patient’s body, thereby triggering a systemic anti-tumor immune response.

Zhenzhi Medicine: Off-the-Shelf Universal mRNA Cancer Therapeutic Vaccine

IPM514 Injection, the first innovative drug developed based on Zhenzhi Medicine's proprietary intellectual property mRNA technology platform, received FDA approval for clinical trials in June this year. IPM514 has also demonstrated immune surveillance effects in postoperative adjuvant animal models, effectively clearing minimal residual lesions and suppressing tumor recurrence. Additionally, preclinical studies observed that the combination of IPM514 with immune checkpoint inhibitors significantly enhanced the anti-tumor activity of T cells, supporting further exploration of combination therapies in clinical settings.

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