Mesutoclax

BEIJING, Aug. 24, 2026 (GLOBE NEWSWIRE) -- InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, today announced the interim results and business highlights for the six months ended 30 June 2026. InnoCare delivered robust revenue growth and strengthened profitability in the first half of 2026, driven by strong commercial execution and global business development collaborations. In the first half of 2026, the Company’s revenue grew by 55.5% year-on-year to RMB 1.1 billion, and profit reached RMB 239.7 million, a turnaround from a loss in the same period last year. These results reflect the successful implementation of the Company’s strategy driven by innovation, commercialization and globalization. In the first half of 2026, InnoCare continued to accelerate innovation, achieving a series of key milestones. 1 NDA approval: Orelabrutinib was approved in Australia.2 NDA acceptances: The NDA applications for orelabrutinib in primary immune thrombocytopenia (ITP) and for zurletrectinib in pediatric solid tumors have been accepted.2 Phase III studies met primary endpoints: The two novel TYK2 inhibitors, soficitinib (ICP‑332) and fadeucravacitinib (ICP‑488), achieved their primary endpoints in the Phase III trials for atopic dermatitis and psoriasis, respectively.3 Phase III trials initiated: Phase III trials were initiated for orelabrutinib in systemic lupus erythematosus (SLE); for the novel BCL2 inhibitor mesutoclax (ICP‑248) in combination with orelabrutinib in relapsed/refractory mantle cell lymphoma (r/r MCL); and for a head-to-head trial of mesutoclax with azacitidine versus venetoclax with azacitidine in treatment naïve (TN) acute myeloid leukemia (AML) in China.4 Investigational New Drugs (IND): The VAV1 molecular glue degrader ICP-538, the novel oral IL-17AA/AF inhibitor ICP-054, and the novel CDH17-targeting ADC ICP-B208 received IND approvals. The IND application for the PSMA- and STEAP1-targeting ADC ICP-B381 has been accepted. Dr. Jasmine Cui, the Co-founder, Chairwoman, and CEO of InnoCare, said, “We have delivered a strong performance in the first half of 2026. We sustained profitability, continued our commercial expansion, achieved milestones across multiple pivotal phase III pipelines with primary endpoints met, and advanced our global footprint. Looking ahead, we will accelerate the implementation of Strategy 2.0, continue to achieve rapid growth in commercialization while advancing innovation and global expansion to benefit patients worldwide.” Financial Highlights Revenue grew by 55.5% year-on-year (YoY) to RMB 1.1 billion in the first half of 2026, mainly driven by robust commercial growth and global business development collaborations. Drug sales increased by 43.2% YoY to RMB 918.1 million for the six months ended 30 June 2026，driven by robust growth of orelabrutinib and the new launches of tafasitamab and zurletrectinib. Profit reached RMB 239.7 million, mainly due to significant commercial growth, global BD, and sustained improvement in cost efficiency. Research and Development Investment increased by 10.5% YoY to RMB 497.1 million for the six months ended 30 June 2026, reflecting our advancements in global clinical development, as well as increased investment in new technology platforms such as ADCs and molecular glue. Cash and Related Accounts Balance stood at approximately RMB 8.4 billion1 as of 30 June 2026. This strong cash position provides InnoCare with the flexibility to expedite global clinical development and invest in new technology platforms. Enhanced Commercialization In the first half of 2026, all four approved indications of orelabrutinib were included in the updated National Reimbursement Drug List (NRDL). Orelabrutinib sales grew rapidly following the NRDL inclusion of the first line chronic lymphocytic leukemia/small lymphocytic lymphoma (1L CLL/SLL) indication, while the orelabrutinib maintained its exclusive indication advantage in marginal zone lymphoma (MZL). Additionally, both tafasitamab and zurletrectinib have been approved for marketing and have begun to contribute to sales. Tafasitamab became the first CD19 antibody approved for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in China, while the next-generation TRK inhibitor, zurletrectinib, is now being prescribed in hospitals across China. As a result, drug sales increased by 43.2% YoY, reaching RMB 918.1 million in the first half of 2026. Leading Franchise in Hemato-Oncology In the first half of 2026, InnoCare made significant progress toward building a leading franchise in hemato-oncology, driven by coordinated advances in commercial execution, late-stage clinical development, and global program expansion across its three cornerstone therapies: orelabrutinib, tafasitamab, and mesutoclax (ICP-248). Orelabrutinib has grown rapidly following the NRDL inclusion of its 1L CLL/SLL indication while maintaining its exclusive indication advantage in MZL. The tafasitamab combination regimen received a Grade I Recommendation for second-line and subsequent-line treatment of diffuse large B-cell lymphoma (DLBCL) in the 2026 CSCO Lymphoma Diagnosis and Treatment Guidelines. Results from the global Phase III frontMIND study of the tafasitamab regimen were published in The Lancet, a top-tier international medical journal, and featured as a high-impact oral presentation at the plenary session of the 2026 European Hematology Association (EHA) Annual Congress. The results demonstrated that, compared with R‑CHOP, the current first‑line standard‑of‑care, the tafasitamab regimen significantly prolonged progression‑free survival (PFS), with the potential to establish a new first‑line standard‑of‑care for patients with DLBCL. As the first BCL2 inhibitor granted Breakthrough Therapy Designation (BTD) in China, mesutoclax has rapidly advanced across multiple clinical programs throughout China and globally, positioning it to become a globally competitive innovative therapy, further consolidating the Company’s leading position in hemato-oncology. 1) The head-to-head registrational Phase III trial of mesutoclax with azacitidine versus venetoclax with azacitidine in treatment naïve (TN) acute myeloid leukemia (AML) was initiated in China, with overall survival (OS) as the primary endpoint. Global clinical development of mesutoclax in AML and myelodysplastic syndrome (MDS) is accelerating in China, the U.S., and Australia. Clinical data of mesutoclax in AML and MDS has been released at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting as an oral presentation, demonstrating outstanding efficacy and safety profiles. As of April 13, 2026, among the evaluable TN AML patients, 81.8% achieved composite CR (cCR, CR+CRi). Among patients who achieved overall response, 86.5% were negative for minimal residual disease (MRD). Among cCR responders, 83% achieved cCR in the first treatment cycle, demonstrating that the mesutoclax regimen enables rapid and deep remission. No dose-limiting toxicities (DLTs) were observed, and the maximum tolerated dose (MTD) was not reached. Notably, both 30-day mortality and 60-day mortality were 0% among TN AML patients. At the recommended dose, the 6-month overall survival (OS) rate was 90.5%.As of April 20, 2026, among evaluable TN MDS patients, the overall response rate (ORR) per IWG 2006 criteria was 100%, including complete response (CR) in 40%, and marrow CR in 60%. The composite CR rate was 90% per IWG 2023 criteria, including 60% CR. 2) The Phase III trial of the fixed-duration combination of mesutoclax with orelabrutinib in 1L CLL/SLL has completed patient enrollment. Data presented at the 2026 ASCO Annual Meeting showed that the combination achieved an overall response rate (ORR) of 100% in 1L CLL/SLL. 3) The registrational Phase II clinical trial of mesutoclax in BTK inhibitor-treated mantle cell lymphoma (MCL) is being expedited and has received Breakthrough Therapy Designation (BTD). It is the first BCL2 inhibitor to receive BTD recognition in China. Data presented at the 2025 ASH Annual Meeting demonstrated an ORR of 84.0% among MCL patients who were BTK inhibitor refractory. 4) The registrational Phase III clinical trial of mesutoclax in combination with orelabrutinib in r/r MCL is ongoing in China. Phase I data presented at the 2026 ASCO Annual Meeting demonstrated that the combination regimen achieved an ORR of 100% in patients with r/r MCL. 5) Mesutoclax in combination with orelabrutinib has been granted BTD in China for the treatment of patients with MZL who have received at least one prior therapy. Data presented at the 2026 ASCO Annual Meeting demonstrated that the combination achieved an ORR of 100%, with an excellent efficacy and safety, in this patient population. Accelerating Autoimmune Pipeline The global market for autoimmune disease therapies is anticipated to reach US$185 billion by 2029. Leveraging our strong capabilities in oral small-molecule drug discovery, InnoCare has built a differentiated and comprehensive autoimmune portfolio targeting both B-cell and T-cell-mediated disease pathways. InnoCare’s strategy focuses on developing first-in-class and best-in-class oral therapies, anchored by orelabrutinib in B-cell-driven diseases and a robust TYK2 franchise addressing T-cell-mediated inflammation. In parallel, the Company has continued to advance early-stage programs targeting novel immune pathways to sustain long-term innovation and portfolio depth. Orelabrutinib The NDA submission for orelabrutinib in Immune thrombocytopenia（ITP）was accepted in China, marking the first NDA acceptance for orelabrutinib in autoimmune diseases and a significant milestone in expanding orelabrutinib beyond hematologic malignancies into autoimmune diseases. This achievement represents an important step toward addressing the significant unmet medical needs of patients with ITP in China. The registrational Phase III clinical trial of orelabrutinib for systemic lupus erythematosus (SLE) has been accelerating patient enrollment. Positive data from the Phase IIb study were presented at the EULAR 2026 European Congress of Rheumatology. The Phase IIb study met its primary and secondary endpoints, making orelabrutinib the first BTK inhibitor to demonstrate significant efficacy in a Phase II clinical trial in SLE. Orelabrutinib is expected to become the first-in-class oral BTK inhibitor for the treatment of SLE. Two global registrational Phase III clinical trials of orelabrutinib in primary progressive multiple sclerosis (PPMS) and secondary progressive multiple sclerosis (SPMS) are ongoing. Four related study abstracts have been accepted for presentation at MSToronto 2026: 1) Efficacy and Safety of Orelabrutinib in Relapsing-Remitting Multiple Sclerosis: 24-Week Results from a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study. 2) Pharmacokinetics of Orelabrutinib in a Phase 2 Study in Relapsing Remitting Multiple Sclerosis. 3) Orelabrutinib in Non-Active Secondary Progressive Multiple Sclerosis: Design of the Monarch Phase 3 Randomized Controlled Trial. 4) Orelabrutinib in Primary Progressive Multiple Sclerosis: Design of the PriMroSe Phase 3 Randomized Controlled Trial. Two TYK2 Inhibitors: Soficitinib（ICP 332）and Fadeucravacitinib（ICP 488） Focusing on multiple T‑cell‑mediated autoimmune diseases, InnoCare has built in‑depth pipeline with two TYK2 inhibitors targeting multiple high-value indications, including atopic dermatitis (AD), psoriasis, vitiligo, prurigo nodularis (PN), chronic spontaneous urticaria (CSU), cutaneous lupus erythematosus (CLE), Sjögren's syndrome (SS) and other dermatological diseases. In the first half of 2026, both TYK inhibitors released multiple pivotal Phase II/III clinical results that met their primary endpoints, positioning them as potentially globally competitive innovative therapies. Soficitinib (ICP-332) 1) The Phase III clinical trial of soficitinib in patients with moderate to severe atopic dermatitis achieved its primary endpoint and multiple key secondary endpoints. The safety profile of soficitinib remained consistent with previous clinical studies, with no new safety signals identified. These findings confirm soficitinib’s excellent efficacy and safety profiles in patients with moderate-to-severe atopic dermatitis. The Company plans to submit an NDA following the completion of the 52-week safety follow-up. 2) The Phase II portion of the Phase II/III trial in non-segmental vitiligo has met its primary endpoint. The Phase II results showed that, at Week 24, treatment with soficitinib resulted in significant improvements from baseline in Facial Vitiligo Area Scoring Index (F-VASI). The least-squares mean percent change from baseline in F-VASI was 38.8% in the 80 mg once-daily group and 41.2% in the 120 mg once-daily group, compared with 2.2% in the placebo group. The two soficitinib dose groups demonstrated statistically significant improvements versus placebo (P<0.0001). Soficitinib also showed a favorable safety profile, consistent with previous clinical studies. The treatment was well tolerated, and no new safety signals were identified. The Company will accelerate Phase III clinical trials. 3) The global Phase II clinical trial for prurigo nodularis (PN) has continued patient enrollment in the U.S. and Europe. 4) The Phase II/III clinical trial for moderate‑to‑severe chronic spontaneous urticaria (CSU) has completed patient enrollment. 5) The Phase II clinical trial for moderate‑to‑severe plaque psoriasis has completed patient enrollment. Fadeucravacitinib (ICP-488) 1) The Phase III clinical study in patients with moderate-to-severe plaque psoriasis achieved its primary endpoint and multiple secondary endpoints, demonstrating a consistent treatment effect across efficacy measures. Fadeucravacitinib also showed a favorable safety profile, which was consistent with previous clinical studies. The treatment was well tolerated, and no new safety signals were identified. 2) The Phase II clinical trial in cutaneous lupus erythematosus (CLE) is being expedited. 3) The Phase II clinical trial in patients with Sjögren’s syndrome (SS) is ongoing. The novel oral IL-17AA/AF inhibitor ICP-054 (ZB021) has successfully enrolled healthy volunteers. The single‑ascending‑dose (SAD) and multiple‑ascending‑dose (MAD) portions of the trial are being conducted in collaboration with Zenas, with data expected to be released by the end of 2026. ICP-054 is a novel, oral, highly potent and selective IL-17AA/AF inhibitor with significant therapeutic potential in autoimmune and inflammatory diseases. ICP-054 blocks signal transduction pathways of both the IL-17AA homodimer and the IL-17AF heterodimer, thereby inhibiting the release of pro-inflammatory cytokines and chemokines, exerting an anti-inflammatory effect. Simultaneously, it reduces excessive proliferation of keratinocytes and inflammatory cell infiltration, improving skin lesions and thus suppressing the occurrence of autoimmune and inflammatory diseases. The first VAV1 degrader (ICP-538) approved to enter clinical trials in China and the second globally has successfully enrolled patients. ICP-538 is a novel, potent, highly selective, orally administered molecular glue degrader targeting VAV1, a key protein downstream of T-cell and B-cell receptors. ICP-538 is being developed for the treatment of hard-to-treat autoimmune diseases, such as inflammatory bowel disease (IBD), SLE, and multiple sclerosis (MS). The CD20xCD3 T-cell engager (TCE) ICP-B02 (PRO-203) has completed single ascending dose (SAD) trials of healthy volunteers for severe autoimmune diseases. Meanwhile, Prolium, InnoCare’s partner, has advanced the clinical development of subcutaneously dosed ICP-B02across multiple severe autoimmune diseases. In June 2026, Prolium initiated a multinational Phase I/II study in systemic sclerosis (SSc) and announced plans to further explore ICP-B02 in additional severe autoimmune diseases driven by aberrant B-cell activity. In June 2026, Prolium also announced completion of the 26-week follow-up of all patients in an investigator-initiated study of ICP-B02 in patients with treatment-refractory lupus nephritis. Building Competitive Solid Tumor Pipeline InnoCare has been building a robust and diversified portfolio to address significant unmet medical needs across multiple tumor types. The Company is committed to combining targeted small molecules with next-generation antibody-drug conjugates (ADCs) to maximize clinical benefit while minimizing systemic toxicity. The R&D team aims to focus on tumor types with high unmet needs, and to develop therapies that are differentiated in mechanism of action, potency, and safety profile. By leveraging our proprietary platforms and biomarker-driven patient selection, the Company seeks to accelerate clinical development, increase the likelihood of regulatory success, and ultimately provide innovative treatment options that improve patient outcomes across diverse solid tumor indications. The next-generation TRK inhibitor zurletrectinib was granted priority review for the treatment of pediatric patients (ages 2–12) with solid tumors harboring NTRK fusions, and the NDA application has been accepted. Zurletrectinib showed outstanding efficacy and safety for pediatric solid tumors, with an ORR of 100% as assessed by the independent review committee (IRC). In December 2025, zurletrectinib received approval for the treatment of adult and adolescent patients (aged 12 years and older) with solid tumors harboring NTRK gene fusions in China. The novel B7-H3 targeted ADC ICP-B794 has successfully begun patient enrollment, and its Phase I dose‑escalation trial is being expedited. Preclinical data was selected for presentation at the 2026 American Association for Cancer Research (AACR) annual meeting, demonstrating superior anti-tumor activity and a significantly larger safety window compared with similar drugs. ICP-B794 is a novel ADC comprising a humanized anti-B7-H3 monoclonal antibody conjugated to a potent in-house developed payload via a protease-cleavable linker. This combination ensures precise targeting of tumor cells while minimizing off-target effects, offering a promising treatment for solid tumors such as lung cancer, esophageal cancer, nasopharyngeal cancer, head and neck squamous cell carcinomas, prostate cancer, and others. The novel CDH17-targeted ADC ICP-B208 has entered clinical development, with patient enrollment underway. ICP-B208 will be developed for the treatment of gastrointestinal cancers, including gastric, colorectal, pancreatic ductal adenocarcinoma, and cholangiocarcinoma. In preclinical studies, ICP-B208 demonstrated potent anti-tumor activity even in CDH17-low tumors. The IND application for ICP‑B381, a novel bi-specific ADC targeting PSMA and STEAP1, has been accepted in China for the treatment of solid tumors including prostate cancer. ICP-B381 is InnoCare’s first dual‑antibody ADC built on its established ADC technology platform. In preclinical studies, ICP-B381 demonstrated robust and dose-dependent antitumor activity in a 22Rv1 human prostate cancer xenograft model, outperforming the corresponding single-target PSMA and STEAP1 ADCs at the same dose, with favorable tolerability. The Company plans to submit an IND application in the U.S. Accelerating Globalization In the first half of 2026, the Company accelerated the implementation of its global strategy. Orelabrutinib was approved in Singapore and Australia, and with the rapid advancement of global clinical trials and milestone achieved from BD collaborations, the Company further consolidated its foundation for global growth. Moving forward, InnoCare will continue to unlock the value of its innovation globally through multiple approaches including out‑licensing, regional collaborations and in‑house capability building, generating additional growth opportunities for all stakeholders and benefiting patients worldwide. To know more about the detailed financial data and business updates of InnoCare 2026 interim results, please log in to https://www.innocarepharma.com/investor/home Conference Call Information InnoCare will host a conference call at 8:30 p.m. Beijing time on August 24 in English and at 9:00 a.m. Beijing time in Chinese on August 25, 2026. Participants must register in advance of the conference call. Details are as follows: For English conference call, please register through the below link: https://goldmansachs.zoom.us/webinar/register/WN_RL8rKILHQzKmByY3BxNOgQ#/registration For Chinese conference call, please register through the below link: https://s.comein.cn/m6jbq2jd Forward-looking Statement This report contains the disclosure of some forward-looking statements. Except for statements of facts, all other statements can be regarded as forward-looking statements, that is, about our or our management's intentions, plans, beliefs, or expectations that will or may occur in the future. Such statements are assumptions and estimates made by our management based on its experience and knowledge of historical trends, current conditions, expected future development and other related factors. This forward-looking statement does not guarantee future performance, and actual results, development and business decisions may not match the expectations of the forward-looking statement. Our forward-looking statements are also subject to a large number of risks and uncertainties, which may affect our short-term and long-term performance. About InnoCare Pharma InnoCare (HKEX: 09969; SSE: 688428) is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing innovative drugs for the treatment of cancers and autoimmune diseases, two therapeutic areas with unmet medical needs worldwide. InnoCare has established comprehensive innovation platforms for drug discovery. To date, the Company has developed a robust product pipeline comprising three approved drugs (orelabrutinib, tafasitamab and zurletrectinib), more than ten innovative drug candidates in clinical development, and multiple programs in preclinical stages. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States. For more information about InnoCare, please visit https://www.innocarepharma.com/en and follow us on LinkedIn. ______________________________1 Include cash and bank balances, other financial assets, and interest receivable Contact MediaInvestorsChunhua Lu 86-10-6660987986-10-66609999chunhua.lu@innocarepharma.comir@innocarepharma.com

看前提示：以下新闻中药物、机构、靶点、适应症、临床试验/结果、专利、交易、转化医学等数据信息，均可至「智慧芽新药情报库」进一步检索查询。 https://synapse.zhihuiya.com/ 本周全球药物研发进展 1. 美国FDA加速批准罕见病基因疗法，Ia型糖原贮积病首款获批疗法诞生8月19日，美国FDA加速批准Ultragenyx Pharmaceutical旗下基因疗法Genglycos（pariglasgene brecaparvovec），作为营养管理的辅助治疗，用于减少8岁及以上Ia型糖原贮积病（GSDIa）成人及儿童患者的每日玉米淀粉摄入量。GSDIa是一种罕见的遗传性疾病，由葡萄糖-6-磷酸酶（G6Pase）缺乏所致，这种酶缺乏会导致机体无法正常将储存的糖原分解为葡萄糖。根据FDA新闻稿，Genglycos是首款获批用于治疗该疾病的疗法。Genglycos是一款基于AAV8载体的一次性基因疗法，旨在将具有功能的G6PC基因递送至肝脏，以恢复患者缺乏的酶，使机体能够释放储存的葡萄糖，并帮助患者在空腹状态下维持稳定的血糖水平。Genglycos的疗效在一项随机、双盲、安慰剂对照研究中进行了评估，研究纳入GSDIa患者，并在给药后随访48周。与安慰剂组相比，Genglycos治疗组患者每日玉米淀粉摄入量较基线平均减少31%，且差异具有统计学意义，达到研究的主要终点。 2. FDA批准创新单抗治疗“石头人症”，来自再生元8月19日，再生元（Regeneron Pharmaceuticals）宣布，美国FDA已批准Pasatru（garetosmab），用于减少成人进行性骨化性纤维发育不良（FOP）患者新发异位骨化（HO）病灶的形成以及经临床医生评估的疾病发作。Pasatru是第二款获FDA批准的FOP治疗药物。根据新闻稿，Pasatru是首个在安慰剂对照试验中显示可减少成人FOP患者新发HO病灶和经临床医生评估的疾病发作、并获得FDA批准的疗法。Pasatru是一款源自VelocImmune技术平台的全人源单克隆抗体，可阻断激活素A（Activin A）。此次获批基于在成人FOP患者中开展的3期OPTIMA试验的疗效和安全性数据。在第56周时，Pasatru 10 mg/kg剂量组（n=23）和3 mg/kg剂量组（n=19）均达到主要终点，与安慰剂组（n=21）相比，在减少新发HO病灶总数方面均显示出积极疗效结果。 3. 恒瑞CFB抑制剂「立康可泮」在华获批上市，治疗PNH8月20日，国家药监局（NMPA）官网显示，恒瑞医药的立康可泮（商品名：恒优达，研发代号：HRS-5965）胶囊获批上市，用于治疗既往未接受过补体抑制剂治疗的阵发性睡眠性血红蛋白尿症（PNH）成人患者。立康可泮是一种小分子补体B因子 （CFB）抑制剂，可降低尿蛋白，延缓肾脏疾病进展。III期HRS-5965-301研究结果显示，立康可泮治疗PNH的疗效优于依库珠单抗（补体C5单抗），达到血红蛋白应答的患者比例显著更高（70.0% vs 11.1%）。 4. 国产第2款！三生制药痛风新药「安弗利奇塔单抗」在华获批上市8月20日，国家药监局（NMPA）官网显示，三生制药的安弗利奇塔单抗（anflekitug，研发代号：SSGJ-613，商品名：益赛那）获批上市。安弗利奇塔单是三生制药自主研发的一款重组抗IL-1β人源化单克隆抗体。从发病机制来说，IL-1β是急性痛风发作的关键介质，靶向抗IL-1β治疗是治疗急性痛风性关节炎的一个有效选择。对于痛风频繁发作且秋水仙碱、非甾体抗炎药和糖皮质激素治疗无效、耐受性差或存在禁忌症的患者，国际指南和中国指南均建议应考虑使用IL-1β或TNF-α拮抗剂。目前全球共3款IL-1β药物获批上市，其余两款为卡那奴单抗（诺华，商品名：Ilaris）和伏欣奇拜单抗（金赛药业，商品名：金蓓欣），后者已在国内获批上市。 5. 康希诺生物吸附破伤风疫苗泰特欣®正式获批 8月21日，康希诺生物股份公司宣布，其自主研发的吸附破伤风疫苗泰特欣®正式获得国家药品监督管理局批准，为我国成人破伤风主动免疫预防提供免疫更强效、保护更持久的全新选择。泰特欣®（吸附破伤风疫苗）采用无动物源培养基发酵工艺，从源头控制外源性致敏风险，产业化规模工艺稳定可控。大规模Ⅲ期临床研究结果显示，泰特欣®免疫效果更强效：免后30天抗体GMC、阳性率和阳转率均可达到较高水平，其中抗体几何平均浓度（GMC）优于对照，可达对照组的1.3倍；在18-45岁加强接种人群中，GMC较对照组提升达86%，免疫优势更为突出。保护更持久，免后6个月抗体阳转率仍达98.25%，与免后30天水平基本一致。 6. 阿斯利康「瑞利珠单抗」第3项适应症在中国获批上市 8 月 20 日，NMPA 官网显示，阿斯利康「瑞利珠单抗」国内再获批一项新适应症（受理号：JXSS2500132/3），用于治疗阵发性睡眠性血红蛋白尿症（PNH）。瑞利珠单抗（ALXN-1210）是阿斯利康斥资 390 亿美元重金收购 Alexion 后获得的重要罕见病管线。这是一款长效 C5 补体抑制剂，在国内，瑞利珠单抗于 2025 年 4 月首次获得 NMPA 批准进入中国，用于治疗抗 AChR 抗体阳性的成人全身型重症肌无力，后又拓展适应症至 NMOSD。本次是该药国内获批的第 3 项适应症。 7. 全球首个！维立志博PD-L1/4-1BB双抗申报上市8月21日，CDE官网显示，维立志博的奥帕替苏米单抗（LBL-024）申报上市，用于既往接受过至少两线系统治疗后进展的肺外神经内分泌癌（EP-NEC）。该药物是全球首个递交上市申请的PD-L1/4-1BB双抗。奥帕替苏米单抗是维立志博开发的一种靶向PD-L1与4-1BB的双特异性抗体，2026年5月，维立志博公布了奥帕替苏米单抗单药三线治疗EP-NEC的I/IIa期研究结果。截至2025年8月18日，45例疗效可评估，ORR为33.3%，DCR为51.1%，其中3例CR，12例PR，8例SD。 8. 国产鼻炎1类新药申报上市，来自天辰生物8 月 20 日，CDE 官网显示，天辰生物的 LP-003 注射液上市申请获得受理，用于季节性过敏性鼻炎适应症，这也是天辰生物首个申报上市的创新药。LP-003 是天辰生物开发的一种具有新型序列设计的抗 IgE 抗体，主要开发用于治疗过敏性疾病。目前，天辰生物已在中国获得 LP-003 针对多种适应症的新药临床试验（IND）批准及/或启动相关临床试验，包括季节性过敏性鼻炎、CSU、过敏性哮喘、CRSwNP 及食物过敏。LP-003 针对花生过敏适应症的 IND 申请亦已获美 FDA 批准。 9. 阿斯利康「阿可替尼」新适应症在中国申报上市8 月 17 日，CDE 官网显示，阿斯利康马来酸阿可替尼片一项新适应症上市申请获得受理。根据公开资料和临床试验进展，本次适应症可能为：与维奈克拉联合，用于既往未经治疗的成人慢性淋巴细胞白血病或小淋巴细胞淋巴瘤（CLL/SLL）。阿可替尼是阿斯利康斥资 40 亿美元收购 Acerta Pharma 55% 股权而获得的一款 BTK 抑制剂。作为全球第 2 款获批上市的 BTK 抑制剂，该药自 2017 年获 FDA 批准上市以来就持续拓展适应症。2025 年，该药的全球销售额达到 35.18 亿美元。 10. 首个国产HER2双抗又一新适应症申报上市 8 月 17 日，CDE 官网显示，石药集团/康宁杰瑞安尼妥单抗注射液一项新适应症上市申请获得受理，适应症为联合多西他赛（白蛋白结合型）一线治疗不可切除或转移性 HER2 阳性成人乳腺癌。此前，该适应症已被纳入优先审评。 安尼妥单抗（研发代号：KN026）是康宁杰瑞宣研发的一款 HER2 双抗，2021 年 8 月，石药集团附属公司津曼特生物与康宁杰瑞达成一项 10 亿元的独家授权许可协议，获得该药在中国内地乳腺癌、胃癌适应症上的排他性开发与独占性商业化许可权。 此前，安尼妥单抗已于 2026 年 5 月获 NMPA 批准上市，联合化疗适用于治疗既往至少接受过一种含曲妥珠单抗治疗方案的局部晚期或转移性 HER2 阳性成人胃或胃食管结合部腺癌患者，成为首个获批的国产 HER2 双抗。就在本月 8 月，安尼妥单抗新辅助治疗 HER2 阳性乳腺癌的新适应症上市申请获得 CDE 受理。 更多资讯，请滑动下方文字 FcRn抑制剂自身免疫性肌炎三期临床成功，股价大涨16% 8月17日，Argenx宣布Efgartigimod治疗自身免疫性肌炎的三期临床获得积极数据，研究达到TIS主要终点，也是首个在IMNM亚型实现疾病活动度临床改善的三期临床试验。Argenx当天股价大涨165，目前市值为618亿美元。ALKIVIA研究是一项随机、双盲、安慰剂对照、多中心、2/3期无缝衔接的临床研究，旨在评估艾加莫德治疗特发性炎症性肌病（IIM或肌炎，三种亚型：免疫介导的坏死性肌病、抗合成酶综合征和皮肌炎）的有效性和安全性。Efgartigimod此前已经获批MG、CIDP、ITP等适应症，此次又在自身免疫性肌炎获得成功。Efgartigimod（艾加莫德）上市以来保持持续的高增长趋势，2026年上半年销售额28.14亿美元，预计全年超过60亿美元。 伏罗尼布wAMD三期临床失败，贝达药业拥有大中华区权益8月17日，EyePoint 公布伏罗尼布（EYP-1901，商品名 Duravyu）治疗湿性年龄相关性黄斑变性（wAMD）的三期临床试验 LUGANO 顶线数据，研究未达到非劣于阿柏西普的主要终点。受此影响，EyePoint 当日股价大跌 67%，目前市值约 4.2 亿美元。Duravyu 由贝达药业的伏罗尼布与 EyePoint 的 Durasert E 缓释技术结合开发而成，伏罗尼布是一款多靶点 VEGFR/PDGFR 抑制剂。在全部受试者中，Duravyu 未达到非劣于阿柏西普的主要终点。EyePoint 随后进行了事后分析：去除 9 例因非 wAMD 病因学导致失明的非对称队列患者后，Duravyu 达到非劣效标准，p 值为 0.0096，但最佳矫正视力（BCVA）仍与阿柏西普相差 2.4 个字母。 因安全事故，  再生元终止一项单抗临床研究8月17日，再生元制药公司（Regeneron）宣布暂停其用于治疗眼部炎症的实验性药物REGN7041的Phase 1/2a期临床试验（即TITAN研究）。该试验旨在评估这一款抗CD3单克隆抗体在非感染性葡萄膜炎（即眼球中层发生的非感染性炎症）患者中的安全与疗效。再生元发言人在声明中表示，这一决定源于在试验中观察到的一起安全事件，导致公司对该治疗方案进行了重新评估，并出于风险与收益考量自愿终止了该项研究。虽然再生元已经对该起安全事件展开了调查，但发言人透露，目前引发该事件的具体根本原因尚未确定。再生元强调患者安全是其首要任务，并表示将继续对试验的数据进行评估分析。此外，再生元并未对媒体关于该不良事件的具体性质、严重程度以及该药物未来整体研发计划等进一步提问做出任何回应。 迪哲医药1类新药拟纳入突破性疗法8 月 17 日，CDE 官网显示，迪哲医药申报的 1 类新药 DZD9008 片拟纳入突破性疗法，用于既往未接受过系统性治疗、携带表皮生长因子受体（EGFR）P 环和 αC 螺旋压缩（PACC）或其他（非 EGFR 20 号外显子插入）罕见突变的局部晚期或转移性非小细胞肺癌（NSCLC）成人患者。舒沃替尼（研发代号：DZD9008）是一款口服、不可逆、针对多种 EGFR 突变亚型的高选择性 EGFR 酪氨酸激酶抑制剂（TKI）。2023 年 8 月，舒沃替尼首个适应症获中国 NMPA 批准上市，用于既往经含铂化疗出现疾病进展或不耐受含铂化疗的 EGFR 20 号外显子插入突变（exon20ins）的局部晚期或转移性 NSCLC 患者。2025 年 7 月，美国 FDA 批准舒沃替尼上市，用于二/后线治疗 EGFR exon20ins NSCLC。 创新核药获FDA批准上市，先通医药拥有中国权益当地时间 8 月 14 日，Lantheus 公司宣布，美国 FDA 已批准 MK-6240 （Florquinitau F 18 注射液，TAUKLARIFY）上市。这是一款靶向 tau 蛋白的新型放射性药物，用于阿尔茨海默病（AD）源性轻度认知功能障碍或 AD 痴呆的辅助诊断。MK-6240 旨在靶向聚集的 tau 蛋白，即神经原纤维缠结 (NFT)，NFT 是包括阿尔茨海默病在内多种神经退行性疾病的关键标志。公开资料显示，MK-6240 最初由默沙东‌开发，先通医药于 2017 年通过下属合资公司‌ Cerveau 获得了其全球开发权利。2023 年，Lantheus 公司通过收购 Cerveau 获得 MK-6240 海外权益，先通医药则保留 MK-6240 在中国的独家开发、生产及商业化权益。目前，这款产品正在中国开展 Ⅲ 期临床研究。 阿斯利康/第一三共ADC一线治疗肺癌III期研究成功8月17日，阿斯利康和第一三共联合宣布Enhertu（德曲妥珠单抗）单药一线治疗非小细胞肺癌（NSCLC）的III期DESTINY-Lung04研究取得了高水平的积极结果。该研究是一项全球性、随机、多中心、开放标签临床试验（n=454），评估了Enhertu对比标准治疗（帕博利珠单抗联合含铂双药化疗）一线治疗携带HER2外显子19或外显子20突变的不可切除的局部晚期或转移性非鳞状NSCLC患者的有效性和安全性。研究的主要终点是无进展生存期（PFS）。结果显示，Enhertu组患者的PFS较标准治疗组实现了统计学显著且临床意义显著的改善。该研究将按计划继续进行，以评估包括总生存期（OS）在内的次要终点。值得一提的是，Enhertu是第一个在III期研究中成功证明单药相较标准治疗作为一线治疗方案能够改善NSCLC患者的PFS的ADC药物。百利天恒EGFR/HER3双抗ADC又一项III期研究成功8月17日，百利天恒宣布，公司自主研发的EGFR/HER3双抗ADC伦康依隆妥单抗/宜泽康®（BL-B01D1/iza-bren），用于非小细胞肺癌的Ⅲ期临床试验（研究方案编号：BL-B01D1-301）中，经独立数据监查委员会（iDMC）判断，在预设的期中分析中达到无进展生存期（PFS）主要终点，OS方面亦观察到获益趋势，其适应症为：既往经EGFR-TKI治疗失败的EGFR敏感突变的局部晚期或转移性非小细胞肺癌。这是伦康依隆妥单抗第四个达到主要终点的III期临床研究，也是全球首个在非小细胞肺癌治疗中达到主要终点的双抗ADC药物III期临床研究。 赛沃替尼+奥希替尼联合疗法III期研究取得积极顶线结果8月17日，和黄医药宣布沃瑞沙® (赛沃替尼) 和泰瑞沙® (奥希替尼) 的联合疗法对比铂类双药化疗用于治疗表皮生长因子受体 (EGFR) 突变非小细胞肺癌患者的SAFFRON III期研究取得积极的顶线结果，显示出具有统计学和临床意义的无进展生存期 (PFS) 和总生存期 (OS) 改善。研究中患者的肿瘤伴有高水平的MET过表达或扩增，并且既往曾接受过泰瑞沙®治疗后疾病进展。沃瑞沙®和泰瑞沙®联合疗法的安全性特征与已知的各药物的安全性保持一致，且没有发现新的安全性问题。数据将于即将召开的学术会议公布，并与全球监管机构共享。基于SACHI III期研究，沃瑞沙®和泰瑞沙®联合疗法已于中国获批用于治疗接受EGFR TKI治疗后疾病进展的伴有MET扩增的EGFR突变的局部晚期或转移性非小细胞肺癌患者。 礼来GLP1R/GIPR双激动剂启动第2项针对抑郁症的III期临床8 月 17 日，药物临床试验登记与信息公示平台官网显示，礼来登记了一项 Brenipatide 注射液在成人抑郁症参与者中的 III 期临床研究。Brenipatide 是一款在研 GLP1R/GIPR 双激动剂，也是继替尔泊肽后，礼来第二款 GLP-1/GIP 双靶点新药，全球最高进度在 Ⅲ 期，尚未获批上市。Brenipatide 是全球首个启动抑郁症 III 期临床的 GLP-1 类产品，本次启动的是一项 Ⅲ 期、多中心、随机、双盲、平行组设计研究（RENEW-MDD-2），旨在成人抑郁症参与者中评价 brenipatide 作为辅助治疗与安慰剂相比，在延迟疾病复发时间方面的有效性和安全性。针对抑郁症，此前礼来已启动另一项 Brenipatide 的 III 期 RENEW-MDD-1研究（CTR20260283），研究主要目的是评估 Brenipatide 作为稳定 SoC 药物治疗方案的辅助治疗，在治疗重度抑郁症方面优效于安慰剂。 阿斯利康终止PD-1/CTLA-4双抗治疗肺癌III期临床8月17日，阿斯利康宣布正在终止PD-1/CTLA-4双抗Volrustomig一线治疗非小细胞肺癌（NSCLC）的III期eVOLVE-Lung02研究。该研究是一项全球性、多中心、随机、开放标签临床试验（n=895），旨在评估Volrustomig联合化疗随后单药对比帕博利珠单抗联合化疗随后单药一线治疗肿瘤表达PD-L1<50%的转移性NSCLC患者的疗效和安全性。研究的双重主要终点为肿瘤表达PD-L1<1%患者的无进展生存期（PFS）和总体生存期（OS）。次要终点包括意向性治疗（ITT）人群（PD-L1<50%）的PFS和OS。这一终止决定是基于独立数据监查委员会（IDMC）的建议。在按计划对试验数据进行审查后，IDMC得出结论，Volrustomig联合方案在PD-L1阴性（PD-L1<1%）人群中不太可能达到PFS和OS主要终点。 潜在first-in-class GLP-1受体拮抗剂达3期主要终点，年内申报上市8月18日，Amylyx Pharmaceuticals宣布，评估其在研多肽疗法avexitide治疗减重手术后低血糖（PBH）的3期LUCIDITY临床试验取得积极顶线结果。Avexitide是一款在研、潜在“first-in-class”的胰高血糖素样肽-1（GLP-1）受体拮抗剂，LUCIDITY是一项多中心、随机、双盲、安慰剂对照研究，共纳入78例接受Roux-en-Y胃旁路术（RYGB）后出现PBH的受试者。研究达到与美国FDA商定的主要终点：与安慰剂相比，avexitide使2级和3级低血糖事件复合发生率降低55%（p=0.000003）。此外，研究还达到全部次要终点，包括通过自我血糖监测（SMBG）评估的2级低血糖事件、通过连续血糖监测（CGM）评估的2级低血糖事件，以及3级低血糖事件均显著减少，且结果具有高度统计学显著性和临床意义。安全性方面，avexitide总体耐受性良好，并表现出良好的安全性特征。Amylyx计划于今年年底前向FDA提交avexitide的NDA。 肿瘤新抗原mRNA疫苗三期临床成功，Moderna大涨90%8月19日，Moderna与默沙东宣布肿瘤新抗原mRNA疫苗mRNA-4157+K药联合辅助治疗黑色素瘤的三期临床INTerpath-001达到主要终点RFS和关键次要终点DMFS。这是可手术黑色素瘤首个证明优于K药单药标准疗法的三期临床试验。mRNA-4157为一种个性化肿瘤疫苗，靶向患者的特异性突变，编码最多至34种新生抗原。mRNA-4157可以激活肿瘤新生抗原的特异性T细胞，进而杀伤肿瘤细胞。受此消息影响，Modenra股价盘前大涨89%，市值达到480亿美元。合作伙伴默沙东股价盘前涨8%，市值增加超200亿美元。 Teva在美国申报一款First-in-Class新药，获优先审评资格8月19日，Teva Pharmaceuticals宣布，美国FDA已受理ecopipam的新药申请（NDA），并授予优先审评资格，PDUFA目标日期为2027年第一季度末。Ecopipam是一款潜在“first-in-class”在研疗法，拟用于治疗儿童Tourette综合征患者，同时已获得FDA孤儿药资格认定。该药通过阻断多巴胺D1受体信号发挥作用；D1受体高敏感性可能与Tourette综合征相关的重复性和强迫性行为有关。此次NDA受理主要基于ecopipam在2b期和3期临床研究中取得的积极数据。2b期研究显示，与安慰剂相比，ecopipam在第12周显著降低患者抽动严重程度，并在耶鲁综合抽动严重程度量表总抽动评分（YGTSS-TTS）方面实现具有统计学显著性和临床意义的改善（p=0.01）。 头对头挑战艾伯维，诺诚健华开展III期临床试验8月18日，诺诚健华宣布，其自主研发的新型BCL2抑制剂mesutoclax（ICP-248）联合阿扎胞苷，头对头对比艾伯维维奈克拉联合阿扎胞苷治疗老年或不接受强化疗（unfit）的初治急性髓系白血病（AML）方案，已获国家药品监督管理局（NMPA）药品审评中心（CDE）批准开展注册性III期临床试验。这是一项治疗老年或unfit初治AML的随机、开放标签、多中心的注册性III期临床研究，其主要终点是总生存期（OS）。Mesutoclax是一款新型口服高选择性BCL2抑制剂。 基石药业在研1类ADC癌症新药获批临床8月19日，中国国家药监局药品审评中心（CDE）官网公示显示，基石药业1类新药注射用CS5007获批临床，拟开发治疗晚期实体瘤。公开资料显示，这是一款EGFR/HER3双特异性抗体偶联药物（ADC），已经于今年6月在澳大利亚获批全球多中心1期临床试验。依托基石药业自主研发的创新ADC技术平台，CS5007由抗EGFR/HER3人源IgG1抗体、基石药业创新的亲水性CSL20连接子，以及临床验证的拓扑异构酶I抑制剂依喜替康（Exatecan）组成。 翰森B7-H3 ADC在华拟纳入优先审评8月21日，CDE网站显示，翰森制药的B7-H3 ADC瑞康立伏妥塔单抗（Risvutatug Rezetecan，研发代号：HS-20093）拟纳入优先审评，适应症为经含铂治疗失败的小细胞肺癌（SCLC）。瑞康立伏妥塔单抗是翰森制药自主研发的靶向B7-H3的抗体偶联药物（ADC），由全人源的B7-H3单克隆抗体与拓扑异构酶抑制剂（TOPOi）有效载荷共价连接而成。2023年12月，翰森制药授予葛兰素史克（GSK）该产品在全球（不含中国内地、香港、澳门、台湾）的开发、生产及商业化独家许可。目前GSK正在海外推进III期临床试验。今年7月10日，瑞康立伏妥塔单抗治疗SCLC的III期ARTEMIS-008研究达到了总生存期（OS）主要终点。这是首个在肿瘤III期临床试验中证实B7-H3 ADC能带来显著OS获益阳性结果的研究。 阿斯利康长效Amylin启动三期临床 8月20日，阿斯利康在Clinicaltrials.gov网站上注册了AZD6234治疗肥胖合并或不合并二型糖尿病的三期临床SELENE 3。该三期临床计划入组500例受试者，预计2028年8月完成。AZD6234为一款长效胰淀素受体激动剂，此前开展多项二期临床试验。阿斯利康围绕减重进行了广泛布局，后期临床阶段的包括小分子GLP-1（诚益生物合作开发）、长效Amylin（AZD6234）、GLP-1/GCG（AZD9550），此外还引进了石药集团月制剂GLP-1/GIP等。同机制上，诺和诺德Amylin已经获得三期临床成功，并递交上市申请，礼来偏向性Amylin表现出更好的疗效，并推进到三期临床阶段，阿斯利康成为第三家推进到三期临床的Amylin。 口服司美格鲁肽启动新3期试验，探索更优低剂量日前，诺和诺德（Novo Nordisk）已启动一项安慰剂对照3期临床试验OASIS 5，旨在为其口服GLP-1减重药物Wegovy（semaglutide，司美格鲁肽）探索更优的较低剂量方案。该研究将在肥胖或超重人群中评估两种尚未披露的口服司美格鲁肽剂量，受试者同时配合低热量饮食并增加身体活动。根据目前Wegovy口服制剂的用药方案，患者以每日1.5 mg起始，随后经过两个中间剂量逐步递增，并在治疗第91天达到25 mg维持剂量。OASIS 5研究的结果未来有望为该药新的剂量方案提供依据。 长期数据公布！K药将一线NSCLC的八年生存率提高到10%以上8月19日，即将于2026年9月12 日~15日，在韩国首尔召开的世界肺癌大会（WCLC）公布摘要数据，默沙东进一步更新了KEYNOTE-189和KEYNOTE-407两项研究的八年随访数据。最新数据显示，NSQ和SQ患者中，8年随访情况下仍然有9.1%和8.6%的患者，未出现疾病进展。而生存率方面，NSQ和SQ患者的8年生存率分别达到了16.1%和11.6%，对照组仅为6.2%和7.1%，也就是将8年死亡风险降低了一半以上，两项临床也将一线非小细胞肺癌的8年生存率提高到10%以上。 民为生物GLP-1/GIP/GCG启动减重三期临床8月21日，民为生物在Clinicaltrials.gov网站上注册了GLP-1/GIP/GCG三靶点激动剂MWN109治疗肥胖或超重的三期临床试验。该三期临床计划入组760例肥胖或超重患者，预计2027年9月初步完成。MWN109设置3个剂量组，采用每周一次皮下注射给药，以安慰剂为对照，治疗周期为52周。同靶点方面，礼来Retatrutide为全球首款GLP-1/GIP/GCG三靶点激动剂，已经在四项三期临床获得成功，减重疗效再创新纪录，与替尔泊肽头对头三期临床预计11月读出主要终点数据。 齐鲁KRAS G12D抑制剂公布首个临床数据近日，2026年世界肺癌大会（WCLC）摘要公开，齐鲁制药自主研发的KRAS G12D抑制剂QLC1101的首个I期临床数据浮出水面。截至2026年2月12日，52例携带KRAS G12D突变的经治非小细胞肺癌（NSCLC）患者入组接受QLC1101（100-1600mg，每日2次，口服）治疗，中位治疗时间为58天。结果显示，在42例可评估疗效的患者中，客观缓解率（ORR）为26.2%，疾病控制率（DCR）为78.6%，中位无进展生存期（PFS）为7.2个月，PFS达到9个月的患者比例为37.4%。在II期推荐剂量（1200mg）队列中，ORR为22.7%（5/31），DCR为90.9%，中位PFS尚未达到，PFS达到9个月的患者比例为67.1%。 上下滚动查看更多 全球交易合作动态 1. 超4亿美元！利奥制药引进一款罕见病新药8月18日，利奥制药（LEO Pharma）宣布已达成协议，将从日本田边制药（Tanabe Pharma Corporation）收购其在研的口服、每日一次的小分子黑素皮质素1受体（MC1R）激动剂dersimelagon的全球权益。该药物针对红细胞生成性原卟啉症（EPP）和X连锁原卟啉症（XLP）进行开发，这两种疾病是罕见且严重的终身遗传性疾病。根据协议条款，利奥制药将向田边制药支付高达4.35亿美元的首付款和近期里程碑付款，以及潜在的下游里程碑付款和基于净销售额的阶梯特许权使用费。 2. 针对登革热，罗氏和GSK达成合作 8月18日，罗氏旗下公司中外制药（Chugai Pharmaceutical）宣布与GSK签署了针对抗登革病毒抗体“AID351”的独家许可协议。该协议是继两家公司于2025年1月30日签署合作协议之后的又一重要进展。根据此次协议，GSK获得了在全球范围内开发、生产以及在成功后商业化AID351的独家权利，该药物预计将用于应对包括登革热在内的黄病毒感染。GSK将负责该资产的临床开发（包括I期临床试验）和生产。作为回报，中外制药将有权根据GSK未来的产品销售额获得特许权使用费，并获得GSK从第三方收取的任何分许可收入的分成。 3. 3.7亿美元！礼来押注离子通道新药研发合作8月17日，OmniAb（NASDAQ:OABI）宣布与礼来就一项新的离子通道项目达成全球合作和许可协议。此次合作利用了OmniAb在离子通道发现和筛选方面的技术平台和专业知识。根据协议条款，OmniAb将获得预付款，并有资格获得高达3.7亿美元的研究、开发和商业里程碑付款，以及全球净销售额的分层特许权使用费。合作开发的治疗靶点和药物形式尚未公开。 4. 复宏汉霖与山德士深化全球战略合作，涉至多10款生物类似药 8月17日，复宏汉霖（2696.HK）宣布与全球生物类似药领域龙头企业山德士（Sandoz）达成深度战略合作，双方将就至多10款单抗及/或抗体偶联药物（ADC）生物类似药资产开展全周期合作。这是继2025年双方就伊匹木单抗生物类似药达成46国商业化合作后，在生物类似药领域的进一步协同升级，也是复宏汉霖全球化战略推进的重要里程碑。根据协议，复宏汉霖将授予山德士除中国外全球范围内至多10款合作产品的独家注册与商业化权利。本次合作的产品多数处于早期开发阶段，双方将从研发初期即深度联动，覆盖开发、监管申报、生产供应、上市商业化及全生命周期管理全链条。 5. 4.9亿美元！BioMarin收购Alesta Therapeutics 8月18日，BioMarin Pharmaceutical Inc.宣布，已就收购Alesta Therapeutics达成最终协议，以获得其核心临床阶段资产ALE1。根据协议条款，BioMarin将以自有现金支付交易对价，Alesta股东将获得2.75亿美元首付款，以及最高达2.15亿美元的开发及注册里程碑付款。Alesta的核心资产ALE1为口服活性小分子药物，拟用于治疗低磷酸酯酶症（HPP），一种由ALPL基因突变引发的罕见遗传性骨病。目前，ALE1正在一项持续的1/2a期临床试验中接受评估，未来若获批准，该药将成为首个靶向PPi代谢通路的口服药物。 6. 恒瑞公布2026H1半年报，收入154.56亿元8月19日，恒瑞医药发布2026年半年度报告。报告期内，公司实现营业收入154.56亿元，其中产品销售收入139.48亿元，同比增长1.87%；归属于上市公司股东的净利润44.65亿元，同比增长0.34%。公司研发投入46.05亿元，同比增长18.96%，占营业收入的29.80%，其中费用化研发投入34.93亿元，同比增长8.21%。 7. 先声药业与瑞阳生物达成合作8月20日，先声药业宣布与瑞阳生物就RSV新药库莱韦拜单抗达成战略合作。根据协议，先声药业将获得库莱韦拜单抗在大中华区的独家商业化权益。目前，库莱韦拜单抗上市许可申请已获CDE受理，并被纳入优先审评审批程序，申报的适应症为用于预防1岁以内新生儿和婴儿因RSV引起的LRTI。截止日前，我国已有两款RSV新药上市：尼塞韦单抗（Nirsevimab，2024/1）与克莱罗韦单抗（Clesrovimab，2026/6）。国产方面，进展最快的除了库莱韦拜单抗，还有珠海泰诺麦博的芮特韦拜单抗，两者均处于上市审评阶段，且都被纳入优先审评。 8. 百时美施贵宝与Chai Discovery达成合作8月20日，Chai Discovery宣布与百时美施贵宝（Bristol Myers Squibb）达成合作，双方将利用人工智能技术推进治疗性抗体的发现。根据合作协议，百时美施贵宝将使用Chai Discovery的先进AI模型及平台能力，包括其分子折叠和分子设计模型，以支持其产品管线中抗体候选分子的发现，并进一步推动构建由AI驱动、能够持续学习的药物发现体系。Chai Discovery利用AI预测并重新设计分子间相互作用，可根据预先设定的标准生成具有特定属性的新生物分子，从而帮助科研人员缩短药物发现周期，并探索传统药物发现方法长期以来较难触及的靶点。 9. 礼来押注下一代RNA疫苗 日前，Amplitude Therapeutics宣布与礼来（Eli Lilly and Company）达成一项战略研究合作及许可协议，双方将共同发现和开发用于传染病的反式扩增RNA（trans-amplifying RNA，taRNA）疫苗候选产品。此次合作初期将聚焦若干尚未披露、存在较高未满足医疗需求的传染病疫苗项目，礼来还拥有最多增加两个传染病靶点的选择权。Amplitude的taRNA技术通过将复制酶与编码抗原的RNA组分分离，旨在为不同疫苗项目提供更灵活的抗原设计、制剂调整和剂量优化空间。根据公司介绍，与其他RNA技术路径相比，taRNA有望实现更高效力、更低给药剂量，并改善可制造性。 往期新药速递周报： 7.27全球新药速递周报 8.3全球新药速递周报 8.10全球新药速递周报 8.17全球新药速递周报 🔍智慧芽生物医药推出「Synapse Lens」，一款专为生物医药从业者打造的Chrome插件，能力由智慧芽新药情报库提供支持。它将成为您的“资讯阅读加速器”，一键将普通网页转化为结构化情报。  Synapse Lens，一款专为生物医药从业者打造的智能信息识别助手（内含安装手册）