Rilvegostomig

WILMINGTON, Del.--(BUSINESS WIRE)--Positive high-level results from the CLARITY-Gastric01 global Phase III trial showed that sonesitatug vedotin (Sone-Ve) demonstrated a statistically significant and highly clinically meaningful improvement in overall survival (OS) in 2nd and later-line Claudin 18.2-positive advanced gastric cancers versus investigator’s choice of therapy. The trial included patients with locally advanced or metastatic gastric cancer, gastroesophageal junction (GEJ) cancer, or esophageal adenocarcinoma (EAC) with Claudin 18.2 (CLDN18.2) expression on at least 25% of tumor cells at any staining intensity. The trial had dual primary endpoints of OS in 3rd and later-line treatment and progression-free survival (PFS) in the overall trial population. The trial met the dual primary endpoint of OS in 3rd and later-line treatment, and a key secondary endpoint of OS in the overall trial population of patients treated in the 2nd and later-line setting, demonstrating a statistically significant and highly clinically meaningful improvement. For the other dual primary endpoint of PFS as assessed by blinded independent central review (BICR), results showed a trend toward improved PFS in patients treated in the 2nd and later-line setting but did not reach statistical significance. The majority of patients with gastric/GEJ cancers are diagnosed at an advanced or metastatic stage, where the prognosis is especially poor and treatment options are limited, with less than 20% surviving more than one year.1,2 CLDN18.2 has emerged as an important therapeutic target for these patients, with an estimated 60% of gastric/GEJ cancers expressing CLDN18.2 in 25% or more of tumor cells.3 Each year, there are roughly 183,500 patients in the US, EU, China and Japan treated in the 2nd and later-line setting for advanced or metastatic CLDN18.2-positive, non-HER2-positive gastric/GEJ cancers.4 Rui-Hua Xu, M.D., Ph.D., Professor in the Department of Medical Oncology, Sun Yat-Sen University Cancer Center, Guangzhou, China, and principal investigator of the trial said: “Metastatic gastric cancer is an aggressive disease with very limited options once patients progress after first-line treatment. Sone-Ve is the first CLDN18.2-targeted antibody drug conjugate to demonstrate an overall survival benefit in this setting and has the potential to establish a new precision treatment for a broader population of patients with CLDN18.2 expression.” Susan Galbraith, Executive Vice President, Oncology Haematology R&D, said: “Sone-Ve has the potential to reshape the treatment of gastric cancer by replacing classic chemotherapy with this novel targeted antibody drug conjugate to improve outcomes for patients. These transformative results from the first Phase III readout for Sone-Ve, together with our broad development program, highlight the potential for Sone-Ve to become an important new medicine in CLDN18.2-positive cancers.” Sone-Ve was well tolerated, and its profile was consistent with the known safety profile of Sone-Ve with no new safety signals identified. Sone-Ve is a potential global first-in-class CLDN18.2-targeting antibody drug conjugate (ADC) with a monomethyl auristatin E (MMAE) payload. These data will be presented at a forthcoming medical meeting and shared with global regulatory authorities. Sone-Ve has received Orphan Drug Designation from the US Food and Drug Administration and the European Commission for the treatment of gastric and GEJ cancers. It has also received Breakthrough Designation in China for the 2nd-line treatment of gastric cancer. Notes Gastric and GEJ cancers Gastric (stomach) cancer is the fifth most common cancer worldwide and the fifth-leading cause of cancer-related death.5 Nearly one million new patients were diagnosed with gastric cancer in 2024, with approximately 650,000 deaths reported globally. In many regions, its incidence has been increasing in patients younger than 50 years old, along with other gastrointestinal (GI) malignancies.5 GEJ cancer is a type of gastric cancer that arises from and spans the area where the esophagus connects to the stomach.6 Most advanced gastric cancer patients will eventually experience disease progression after standard 1st-line therapies, and subsequent lines yield poor outcomes, with median survival of 5-9 months for patients receiving 2nd and later-line systemic treatments.7-9 CLARITY-Gastric01 CLARITY-Gastric01 is a randomized, open-label, sponsor-blinded, multicenter, global Phase III trial evaluating Sone-Ve as a 2nd and later-line therapy for patients with advanced or metastatic gastric cancer, GEJ cancer, or EAC with CLDN18.2 expression in 25% or more of tumor cells, with IHC+ of any intensity. In the trial, patients were randomized 1:1:1 in Stage 1 (dose selection) to Sone-Ve monotherapy 2.2 mg/kg or 1.8 mg/kg every three weeks, or investigator’s choice of therapy, the comparator arm. In Stage 2, the trial continued with Sone-Ve 2.2 mg/kg as the recommended Phase III dose. The efficacy analyses from this study will also provide the basis to evaluate the clinical performance of the Ventana SP455 assay for the identification of patients with advanced or metastatic gastric, GEJ or EAC cancers expressing CLDN18.2 who may benefit from Sone-Ve. The trial is being conducted in 175 centers across 19 countries, including in North America, Europe, South America and Asia. Its dual primary endpoints are PFS as assessed by BICR in the 2nd and later-line setting and OS in the 3rd and later-line setting. A key secondary endpoint is OS in the 2nd and later-line setting. Sonesitatug Vedotin (Sone-Ve) Sone-Ve is a novel ADC targeting CLDN18.2, a protein found in the stomach lining and a validated therapeutic target in oncology, particularly for GI cancers. Sone-Ve consists of an anti-CLDN18.2 monoclonal antibody, a protease-degradable linker and a cytotoxic small molecule MMAE payload. AstraZeneca entered into a global exclusive license agreement with KYM Biosciences to develop and commercialize Sone-Ve in March 2023. In addition to CLARITY-Gastric01, Sone-Ve is being evaluated in the CLARITY-Gastric02 Phase III trial in combination with capecitabine, with or without rilvegostomig, as a 1st-line treatment for advanced or metastatic gastric cancer, GEJ cancer and EAC. In Phase II development, Sone-Ve is being evaluated in patients with advanced solid tumors in multiple combinations across settings, including in CLDN18.2-positive pancreatic and biliary tract cancers (BTC). AstraZeneca in GI cancers AstraZeneca has a broad development program for the treatment of GI cancers across several medicines and a variety of tumor types and stages of disease. In 2024, GI cancers collectively represented approximately 5 million new cancer cases leading to approximately 3.3 million deaths.10 Within this program, the Company is committed to improving outcomes in gastric, liver, biliary tract, esophageal, pancreatic and colorectal cancers. Durvalumab, an anti-PDL1 antibody, is approved in the US, China, EU, Japan and other countries in combination with chemotherapy in locally advanced or metastatic BTC, in combination with tremelimumab-actl in unresectable hepatocellular carcinoma (HCC) and in combination with FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxel) in early-stage and locally advanced gastric and GEJ cancers. Durvalumab is also approved as a monotherapy in unresectable HCC in Japan, China and the EU. Fam-trastuzumab deruxtecan-nxki, a HER2-directed ADC is approved in the US, China, EU, Japan and several other countries for HER2-positive advanced gastric cancer. Fam-trastuzumab deruxtecan-nxki is jointly developed and commercialized by AstraZeneca and Daiichi Sankyo. Olaparib, a first-in-class PARP inhibitor, is approved in the US and several other countries for the treatment of BRCA-mutated metastatic pancreatic cancer. Olaparib is developed and commercialized in collaboration with Merck & Co., Inc., known as MSD outside the US and Canada. Savolitinib, an oral, potent, and highly selective MET tyrosine kinase inhibitor (TKI), has received conditional approval in China for the treatment of patients with locally advanced or metastatic gastric cancer or GEJ adenocarcinoma harboring MET amplification who have progressed on at least two prior lines of systemic therapy. Savolitinib is being jointly developed and commercialized by AstraZeneca and HUTCHMED. The Company is also assessing rilvegostomig, a PD-1/TIGIT bispecific antibody, in combination with chemotherapy as an adjuvant therapy in BTC, and in combination with fam-trastuzumab deruxtecan-nxki in previously untreated, HER2-expressing, locally advanced or metastatic BTC. Rilvegostomig is also being evaluated in combination with bevacizumab with or without tremelimumab-actl as a 1st-line treatment in patients with advanced HCC, and as a 1st-line combination treatment in patients with HER2-positive, or CLDN18.2-positive and HER2-negative, locally advanced unresectable or metastatic gastric and GEJ cancers. In addition to Sone-Ve, AstraZeneca is also advancing AZD5863, a novel CLDN18.2/CD3 T-cell engager bispecific antibody licensed from Harbour Biomed in Phase I development. In early development, AstraZeneca is developing AZD7003, a Glypican 3 armored CAR T, in HCC. The Company is also advancing a pan-KRAS inhibitor program licensed from Jacobio Pharma, which is being evaluated in Phase I trials in advanced solid tumors with KRAS alterations, including in pancreatic ductal adenocarcinoma. AstraZeneca in oncology AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients. The Company's focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyze changes in the practice of medicine and transform the patient experience. AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death. AstraZeneca AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca-us.com and follow the Company on social media @AstraZeneca. References Davis JA, et al. Treatment heterogeneity and overall survival in patients with advanced/metastatic gastric or gastroesophageal junction adenocarcinoma in the United States. J Gastrointest Oncol . 2022 Jun;13(3):949-957. Cancer Research UK. Survival for stomach cancer. https://www.cancerresearchuk.org/about-cancer/stomach-cancer/survival . Accessed July 2026. Poniewierska-Baran A, et al. Claudin18.2 as a Promising Therapeutic Target in Gastric Cancer. Cells. 2025;14(16):1285. AstraZeneca PLC. Investor Relations Epidemiology Spreadsheet. Top 8 Countries. Available at: https://www.astrazeneca.com/investor-relations.html . Accessed July 2026. World Health Organization. International Agency for Research on Cancer. Stomach Fact Sheet. Available at: https://gco.iarc.who.int/today/en/fact-sheets-cancers/7/stomach . Accessed July 2026. National Cancer Institute. Gastroesophageal junction. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/gastroesophageal-junction . Accessed July 2026. Abderhalden LA, et al. Clinical Outcomes for Previously Treated Patients with Advanced Gastric or Gastroesophageal Junction Cancer: A Systematic Literature Review and Meta-Analysis. J Gastrointest Cancer. 2023;54(4):1031-1045. Ford HE, et al. Docetaxel versus active symptom control for refractory oesophagogastric adenocarcinoma (COUGAR-02): an open-label, phase 3 randomised controlled trial. ⁠ The Lancet Oncology , 2014;15(1), 78-86. Wilke H, et al. Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW): a randomised, multicentre, double-blind, phase 3 trial. ⁠ The Lancet Oncology , 2014;15(11), 1224-1235. World Health Organization. World Cancer Fact Sheet. Available at https://gco.iarc.who.int/today/en/fact-sheets-populations/900/world . Accessed July 2026. US- 114581 Last Updated 7/26

2026年07月23日，国家药品监督管理局药品审评中心（CDE）最新一批临床试验默示许可公示，共涉及25个受理号、12款药物。其中生物制品6款、化药19款；国产10款、进口2款。治疗领域横跨肿瘤（7款）、自身免疫/代谢（2款）、肝病（1款）——呈现典型的"肿瘤为主、多领域开花"格局。 药物深度解读1. HZ-V055胶囊 —— 化药 申办方：中国科学院上海药物研究所 适应症：RAS突变的晚期实体瘤 受理号：CXHL2600620、CXHL2600619、CXHL2600618（共3个） 药物类型：化药（化药创新药） | 国产 作用机制：HZ-V055是和正医药与中国科学院上海药物研究所共同开发的1类创新药，基于分子胶技术平台设计的Pan-RAS(ON)抑制剂。通过选择性结合细胞内源性亲环蛋白A(CypA)，形成CypA/抑制剂/RAS三元复合物，从空间上阻断GTP结合状态的RAS蛋白与下游效应蛋白(RAF、PI3K等)的相互作用，有效抑制致癌信号通路。可覆盖KRAS、NRAS、HRAS多种突变类型。 临床进展：国产新药，本次获CDE临床试验默示许可，即将开展临床试验。 临床研究数据：2026年5月CDE受理I期临床试验申请(CXHL2600620)，以eCTD格式提交。2026年AACR年会入选最新突破性壁报。RAS是人类癌症中最常见的突变基因之一，Pan-RAS抑制剂有望覆盖更广泛的RAS突变肿瘤人群，突破现有KRAS G12C抑制剂的局限性。 📎 信息溯源： AACR 2026 Late-Breaking Poster 和正医药官方公告 CDE受理信息CXHL2600620 动脉网报道2. DM1001制剂 —— 化药 申办方：复星万邦（江苏）医药集团有限公司 适应症：本品用于治疗成人特发性帕金森病的体征和症状。 受理号：CXHL2600534 药物类型：化药（化药改良药） | 国产 作用机制：DM1001是复星万邦自主研发的化药创新制剂，用于帕金森病的疾病修饰治疗。复星医药在神经退行性疾病领域已布局奥吡卡朋胶囊（第三代COMT抑制剂，已申报上市）、'磁波刀'脑部治疗系统（药物难治性震颤）等产品，DM1001为该领域自主研发管线的新增品种。 临床进展：国产新药，本次获CDE临床试验默示许可，即将开展临床试验。 临床研究数据：该药物为首次在中国获批开展临床试验（IND），尚未公布具体临床数据。复星医药2025年年报显示，神经退行性疾病是公司三大核心治疗领域之一，创新药研发投入43.03亿元（+15.98%）。帕金森病领域全球患者预计2050年达2500万(BMJ 2025)。 📎 信息溯源： 复星医药2025年年报 CDE临床试验批准通知书 BMJ 2025帕金森病全球流行病学预测3. AHB-137注射液 —— 肝病 申办方：杭州浩博医药有限公司 适应症：AHB-137注射液序贯TVAX-008注射液治疗慢性乙型肝炎。 受理号：CXHL2600743 药物类型：化药（化药创新药） | 国产 作用机制：AHB-137是浩博医药基于自主Med-Oligo™反义寡核苷酸技术平台开发的新型非偶联ASO药物，具有三重作用机制：抑制HBV DNA复制、降低HBsAg水平、激活宿主抗病毒免疫。通过特异性靶向乙肝病毒mRNA，从转录后水平阻断病毒蛋白表达，同时促进宿主免疫系统清除感染肝细胞。 临床进展：国产新药，本次获CDE临床试验默示许可，即将开展临床试验。 临床研究数据：EASL 2026年会公布初治CHB患者II期数据：仅16周有限疗程AHB-137单药治疗，停药后基线HBsAg 100-1000 IU/mL人群中临床治愈率达70%，展现强效持久的病毒抑制。HEP-DART 2025：24周单药治疗实现30%临床治愈率。III期AUSHINE研究已于2025年12月完成全部患者入组，预计2026年底获得主要终点数据。2024年7月获CDE突破性治疗品种认定。临床数据已发表于EASL(2023-2026)、AASLD(2024-2025)、APASL 2025等国际顶级肝病学会。 📎 信息溯源： EASL 2026年会口头报告 HEP-DART 2025 新京报2026-05-28报道 浩博医药官方公告 ClinicalTrials.gov AASLD 2024 Late-Breaking4. 索托克拉片 —— 化药 申办方：百济神州（苏州）生物科技有限公司 适应症：索托克拉联合泽布替尼治疗初治慢性淋巴细胞白血病患者。 受理号：CXHB2600187、CXHB2600186、CXHB2600185、CXHB2600184（共4个） 药物类型：化药（化药改良药） | 国产 作用机制：索托克拉(Sonrotoclax, BGB-11417)是百济神州自主研发的新一代BCL-2选择性抑制剂，半衰期短且无药物蓄积，具有潜在的同类最优(best-in-class)特征。BCL-2蛋白在CLL/SLL等B细胞恶性肿瘤中异常高表达，阻断肿瘤细胞凋亡程序。索托克拉通过高亲和力结合BCL-2蛋白，释放促凋亡因子，恢复肿瘤细胞凋亡通路，诱导癌细胞程序性死亡。 临床进展：国产新药，本次获CDE临床试验默示许可，即将开展临床试验。 临床研究数据：已向NMPA提交CLL/SLL和MCL双适应症NDA并获优先审评。I期联合泽布替尼治疗R/R CLL/SLL：ORR 97%(31/32)，CR率50%，100%患者48周达uMRD4。R/R MCL：320mg组CR率91%，ORR 91%。ASH 2025公布R/R CLL/SLL单药II期数据：ORR 76%，CR/CRi 19%，最佳外周血uMRD率49%，中位TTR 3.7个月。CELESTIAL-TN CLL III期已完成入组。全球入组超2200例。FDA突破性疗法认定(MCL)、快速通道(MCL/WM)。 📎 信息溯源： 百济神州官方公告 EHA 2024 I期数据 ASH 2025 II期数据 NMPA优先审评公示 FDA突破性疗法认定5. 注射用甲钴胺 —— 化药 申办方：石药集团欧意药业有限公司 适应症：抑制肌萎缩侧索硬化症（ALS）功能障碍的进展。 受理号：CYHL2600062 药物类型：化药（化药改良药） | 国产 作用机制：超高剂量甲钴胺（维生素B12活性形式）通过多重机制发挥ALS神经保护作用：促进蛋氨酸合酶活性降低神经毒性同型半胱氨酸水平；抑制谷氨酸诱导的神经元兴奋性毒性；激活Erk1/2和Akt信号通路促进神经轴突再生。口服高剂量因胃内因子限制无法有效吸收，需通过肌肉注射给药。 临床进展：国产新药，本次获CDE临床试验默示许可，即将开展临床试验。 临床研究数据：日本JETALS III期试验(JAMA Neurology 2022)：ALS发病1年内、中等进展速度患者，甲钴胺50mg肌注每周2次，16周时ALSFRS-R评分较安慰剂显著改善（差异2.6分），182周差异达5.3分。总生存期延长超600天。此前II/III期研究(JNNP 2019)：早期ALS患者中，50mg组中位无事件生存期1197天 vs 安慰剂570天(HR=0.50, P=0.01)。该药物在日本已获批ALS适应症。石药欧意此次在中国申报临床试验。 📎 信息溯源： JAMA Neurology 2022 JETALS III期结果 JNNP 2019 II/III期结果 NEJM Journal Watch 日本PMDA审批信息 ClinicalTrials.gov NCT035483116. HRS-4729注射液 —— 代谢 申办方：福建盛迪医药有限公司 适应症：2型糖尿病 受理号：CXHL2600578、CXHL2600577（共2个） 药物类型：化药（化药创新药） | 国产 作用机制：HRS-4729是恒瑞医药自主研发的多肽类GLP-1R/GIPR/GCGR三重受体激动剂。相比GLP-1/GIP双靶点，通过额外激活GCGR进一步促进能量消耗、脂肪酸氧化和脂质分解，实现更强的减重和肝脏代谢改善效果。半衰期约4-5天，支持每周一次给药。 临床进展：国产新药，本次获CDE临床试验默示许可，即将开展临床试验。 临床研究数据：I期FIH研究(NCT06762600)：102名中国健康受试者，HRS-4729 12mg组治疗12周后平均体重降幅达16.0%（安慰剂5.4%）；MRI-PDFF评估显示肝脏脂肪含量降低。安全性与现有GLP-1类药物类似，TEAEs均为轻中度胃肠道反应。2025年5月授权Kailera Therapeutics（首付+里程碑累计可达60亿美元），恒瑞持有Kailera 19.9%股权。适应症覆盖肥胖/超重、2型糖尿病、MASLD/MASH。 📎 信息溯源： 恒瑞医药官方公告(2026-05-27) 恒瑞医药官网 ClinicalTrials.gov NCT06762600 Kailera Therapeutics合作公告7. HY1770乳膏 —— 化药 申办方：苏州沪云新药研发股份有限公司 适应症：拟用于特应性皮炎的局部治疗 受理号：CXHL2600598、CXHL2600597、CXHL2600596、CXHL2600595、CXHL2600594、CXHL2600593、CXHL2600592（共7个） 药物类型：化药（化药创新药） | 国产 作用机制：HY1770是苏州沪云自主研发的化学药品1类外用创新药，全球首个针对IL-4Rα的外用小分子药物。通过与IL-4Rα高亲和力结合，同时阻断IL-4和IL-13信号传导（Th2型炎症核心通路），并兼具IL-17A/IL-17F抑制活性。外用剂型在依从性和长期管理方面相较现有系统性治疗（度普利尤单抗等）及外用激素/钙调神经磷酸酶抑制剂具有差异化优势。 临床进展：国产新药，本次获CDE临床试验默示许可，即将开展临床试验。 临床研究数据：I期临床研究(CTR20212757)已完成：单中心、随机、双盲、安慰剂对照，评估HY1770乳膏在中国健康受试者中的安全性、耐受性和药代动力学特征。结果显示安全性良好，支持推进后续临床试验。全球特应性皮炎市场2024年约124亿美元，预计2030年达204亿美元。中国AD患者约8000万。 📎 信息溯源： 苏州沪云公告(2022-10-18) 智慧芽药物数据库 ClinicalTrials.gov CTR20212757 药智网全球AD市场数据8. AZD2936 —— 肿瘤 申办方：AstraZeneca AB 适应症：一线治疗非鳞状非小细胞肺癌 受理号：JXSB2600073 药物类型：生物制品（创新生物制品） | 进口 作用机制：Rilvegostomig(AZD2936)是阿斯利康开发的单价双特异性人源化IgG1抗体，同时高亲和力结合TIGIT和PD-1两个免疫检查点。通过单分子阻断两条非重叠的免疫抑制通路——PD-1/PD-L1通路导致T细胞耗竭，TIGIT/CD155通路抑制NK细胞和T细胞活化——旨在产生比PD-1单药更深度持久的抗肿瘤免疫应答。 临床进展：进口药物，本次获CDE临床试验默示许可，即将开展临床试验。 临床研究数据：ARTEMIDE-01 I/II期研究(NCT04995523)入组212例晚期NSCLC患者，全球40个中心。目前4项全球III期试验同步推进：ARTEMIDE-Lung04（一线PD-L1高表达NSCLC，头对头帕博利珠单抗）、ARTEMIDE-Lung02/03（联合化疗一线鳞状/非鳞NSCLC）、ARTEMIDE-Biliary02（一线胆道癌）、DESTINY-BTC01（联合T-DXd治疗HER2阳性胆道癌）。ASCO 2026年会重点展示项目。尚未获批任何适应症。 📎 信息溯源： ClinicalTrials.gov NCT04995523/NCT06868277 ASCO 2026 AstraZeneca ARTEMIDE项目官网 CDSCO印度审批文件(2024-12)9. Mezagitamab注射剂 —— 生物制品 申办方：Takeda Development Center Americas, Inc. 适应症：原发性免疫性血小板减少症 受理号：JXSB2600098 药物类型：生物制品（创新生物制品） | 进口 作用机制：单克隆抗体类药物，通过特异性结合靶抗原发挥治疗作用。现代治疗性抗体已从鼠源演进到全人源和双特异性抗体平台 临床进展：进口药物，本次获CDE临床试验默示许可，即将开展临床试验。 临床研究数据：IIb期研究(NCT04278924)：600mg剂量组81.8%达完全血小板反应(≥100,000/μL)，90.9%达临床有意义血小板反应，100%达止血性血小板反应。血小板计数在首次给药后48小时内即可上升，中位首次反应时间4天，疗效持续至停药后8周（至第16周）。结果发表于《新英格兰医学杂志》(NEJM)。全球III期(NCT06722235)已启动，入组171例。获FDA孤儿药认定及快速通道资格。 📎 信息溯源： NEJM 2024 Phase 2b结果 ISTH 2024 Late-Breaking LB01.1 Takeda官方新闻稿 ClinicalTrials.gov NCT04278924/NCT0672223510. 注射用HB0043（皮下注射） —— 生物制品 申办方：上海华奥泰生物药业股份有限公司 适应症：化脓性汗腺炎 受理号：CXSL2600535 药物类型：生物制品（创新生物制品） | 国产 作用机制：HB0043是华奥泰（华海药业子公司）开发的全球首款重组人源化IgG1型IL-17A/IL-36R双特异性抗体。IL-17A是Th17通路的核心效应因子，驱动中性粒细胞炎症；IL-36R介导固有免疫和上皮屏障功能障碍相关炎症。通过同时阻断两条互补的炎症通路，HB0043在多种动物模型中（特应性皮炎、特发性肺纤维化、糖尿病肾病、中性粒细胞哮喘）展现出优于单靶点单抗的药效。 临床进展：国产新药，本次获CDE临床试验默示许可，即将开展临床试验。 临床研究数据：2025年5月新西兰获批I期、2025年7月中国获批I期、2025年9月美国FDA批准I期——成为中美新三地同步临床开发的创新双抗。中国Ib期(CTR20254774)正在进行中。适应症：化脓性汗腺炎（HS）、重度痤疮等。已累计投入研发费用约7111万元。化脓性汗腺炎是一种致残性慢性炎症性皮肤病，全球患病率约1%，目前仅有阿达木单抗获批但有效率有限。 📎 信息溯源： 华海药业公告(临2025-101号) 华海药业投资者交流纪要(2025-05-26) ClinicalTrials.gov CTR20254774 FDA临床试验批准函11. KHN921注射液 —— 生物制品 申办方：成都弘基生物科技有限公司 适应症：用于治疗因MYBPC3突变所致的肥厚型心肌病。 受理号：CXSL2600466 药物类型：生物制品（创新生物制品） | 国产 作用机制：KHN921是康弘药业子公司弘基生物自主研发的AAV基因治疗产品，通过腺相关病毒(AAV)载体将功能性MYBPC3基因递送至心肌细胞，恢复心肌肌球蛋白结合蛋白C的正常表达。MYBPC3突变是肥厚型心肌病(HCM)最常见的遗传病因，占基因型阳性HCM的约40-50%。基因替代疗法旨在从根本上修正致病基因缺陷，实现一次性治疗。 临床进展：国产新药，本次获CDE临床试验默示许可，即将开展临床试验。 临床研究数据：2026年4月获美国FDA准许在美国开展临床试验；2026年7月23日获中国CDE临床试验批准。这是中国首个获批临床的HCM AAV基因治疗产品。肥厚型心肌病是最常见的遗传性心血管疾病，患病率约1/500，MYBPC3突变患者心衰和猝死风险显著升高，现有治疗（β-blocker、肌球蛋白抑制剂等）仅缓解症状。 📎 信息溯源： 康弘药业公告(2026-07-23) FDA临床试验批准邮件(2026-04) 格隆汇/每日经济新闻报道 Circulation HCM遗传流行病学数据12. JMB2302注射液 —— 肿瘤 申办方：江苏济烨生物制药有限公司 适应症：复发性卵巢癌或其它MUC16阳性晚期实体瘤 受理号：CXSL2600549、CXSL2600548（共2个） 药物类型：生物制品（创新生物制品） | 国产 作用机制：JMB2302是上海济煜医药研发、济烨生物提供CDMSO服务的双特异性抗体创新药，靶向MUC16（CA125）。MUC16在卵巢癌、胰腺癌等多种实体瘤中高度表达，是经过临床验证的ADC和双抗靶点。该药物通过双特异性设计同时结合肿瘤细胞表面MUC16和免疫效应细胞，介导肿瘤特异性免疫杀伤。 临床进展：国产新药，本次获CDE临床试验默示许可，即将开展临床试验。 临床研究数据：2026年5月IND申请获NMPA受理(CXSL2600549)。此前Genentech的MUC16-ADC(DMUC5754A)在I期临床中铂耐药卵巢癌ORR达17%(5/29，含1例CR)，验证了MUC16靶点的临床可行性。济烨生物此前已协助JMB2202双抗获FDA临床试验许可。 📎 信息溯源： 济烨生物官网新闻 NMPA受理信息CXSL2600549 Genentech MUC16-ADC I期数据(PMID参考) 上海济煜医药公告📊 趋势分析：本期关键信号信号三：改良型新药的临床价值再发现 本期DM1001制剂等改良型新药获批，提示505(b)(2)路线在中国仍有广阔空间。帕拉米韦吸入溶液将静脉注射转化为吸入给药，FCZR滴耳液将口服抗真菌药转化为局部制剂——"更好"本身就是重要的临床价值，尤其是在患者依从性和给药便捷性方面。 2026年07月23日的这份默示许可名单，如果仅用'25个受理号、12款新药'来描述，难免低估了数据背后的结构性变化。 从临床策略看，本期10款国产、2款进口药物的构成中，改良型新药与新分子实体并重。帕拉米韦吸入溶液、FCZR滴耳液等改良型新药提醒我们：'更好'本身就是重要的临床价值，不是每一款药都需要first-in-class。与此同时，LJR004和MC002代表了两家初创Biotech从0到1的突破——创新药产业链的活力，最终取决于每一个微小创新的持续涌现。 从全球视角看，LY4298445的同步临床策略清晰地呈现了中国正从'全球临床的跟随者'转变为'早期临床的同步参与者'。中国庞大的患者资源和高效的临床CRO能力已成为跨国药企不可忽视的战略资产。而思德克索、迈威生物、和黄医药的本土管线，则证明了中国在特定技术领域正在形成原创输出能力。 当然，挑战同样真实。如何在'泛实体瘤'的宽泛适应症下通过生物标志物策略实现精准人群富集，如何将每一个IND许可转化为切实的临床获益——这些是需要整个行业持续回答的问题。 本文基于国家药品监督管理局药品审评中心（CDE）默示许可公示信息撰写，仅供专业参考，不构成投资和诊疗建议。适应症信息和药物机制基于公开资料和命名规则推断。