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产业动态｜中国生物制药：创新药78.1亿增29%，乙肝突破 AI加持下，中国生物制药研发经营持续腾飞，中报业绩出色，2026H1实现收入194.4亿元（yoy+10.6%），经调归母净利润33.4亿元（yoy+92.3%）。在创新药收入保持高增（收入78.1亿元，yoy+29.1%）的背景下，公司经营效率大幅度提升，销售+管理费用率从2025H1的42.9%降至2026H1的32.0%，其中AI大幅度赋能公司经营管理效率。销售方面，AI赋能全体销售：推广效率提高30%，人均单产显著提升，部分项目销管费用下降5~20%。生产方面，生产AI赋能全类型资产，PD-L1抗体产量提高20%以上，制造成本下降20%以上，处于行业头部水平。AIDD管线POC验证，研发效率持续提升 公司AI驱动新药的FIC新药TRD205（靶向AT2R）用于慢性术后神经病理性疼痛（CPSNP）的Ⅱ期临床试验取得关键性突破成果。基于此次临床试验的积极进展，2026年7月TRD205同步被CDE纳入突破性疗法认定。TRD205基于集团第二代AI药物发现平台开发，标志着中国生物制药以AI驱动原创新药研发的能力，正在加速转化为具有全球竞争力的临床成果。此前诺华的同靶点产品EMA401临床试验中止，公司的TRD205的设计思路有望极大加强AT2R的选择性，从而避免脱靶毒性等一系列问题。两笔license-out证明研发实力提升 2026年7月8日，公司宣布与AZ就PDE3/4抑制剂（TQC3721）订立独家授权协议，取得2亿美元预付款，潜在总额21亿美元，以及最高双位数百分比的分级销售分成。2026年3月4日，公司宣布其JAK/ROCK罗伐昔替尼授权给Sanofi，首付款1.35亿美金，潜在总交易金额达15.3亿美金，以及最高双位数的提成。license-in增厚收入，乙肝领域迎来突破 2026年5月11日，中国生物制药宣布与GSK达成独家战略合作，加速FIC新药Bepirovirsen在中国的上市进程。根据协议条款，正大天晴将负责Bepirovirsen在中国内地商业化（全部计入收入），GSK将继续作为MAH。2026年初Bepirovirsen已向CDE递交上市申请，并被纳入优先审评品种名单，有望成为首款实现慢性乙肝功能性治愈的药物，为国内乙肝治疗领域带来革命性突破。股权回收有望增厚利润 此前中国生物制药CEO通过股权激励平台、天晴高管收回正大天晴5%的少数股权，目前已启动转卖给上市公司的程序。交易完成后，上市公司持有正大天晴股份（2025年收入134亿元，净利润58亿元）将增至65%，直接增厚归母净利润。 研报认为，中国生物制药2026年在AI运用、经营效率、创新药销售、license-in、license-out、股权增厚等方面均有进展。根据wind一致预期，当前PE为19x。 风险提示：本文整理自券商研报纪要/公开信息，不构成任何投资建议。股市有风险，决策需谨慎。 一手调研资源 行业研究报告 如体验卡过期，请移步最新文章 关注点火调研⬆️⬆️⬆️获取一手资讯

近日，人福医药自主研发的AT2R拮抗剂HW243040片Ⅰ期临床试验顺利完成首例入组，标志着该产品正式进入人体试验阶段。这项Ⅰ期、随机、双盲、单中心、剂量递增、安慰剂对照临床研究，旨在评价HW243040在健康研究参与者中的安全性、耐受性、药代动力学及药效动力学等，该项临床研究由中南大学湘雅三医院阳国平教授承担主要研究者。 01 关于周围神经病理性疼痛 神经病理性疼痛是由躯体感觉系统损伤或疾病导致的一种慢性疼痛。根据损伤或疾病的解剖位置，可以分为周围神经病理性疼痛和中枢神经病理性疼痛，临床上周围神经病理性疼痛较常见。其中痛性糖尿病周围神经病变（painful diabetic peripheral neuropathy, PDPN）和带状疱疹后神经痛（postherpetic neuralgia, PHN）是周围神经病理性疼痛中发病率最高的两大亚型。PDPN作为糖尿病最常见的慢性并发症，患病率为 8.0%～26.0%，在伴有糖尿病周围神经病变的2型糖尿病病人中，PDPN患病率高达57.2%，并且目前仍存在诊断率偏低、治疗方案不规范等问题[1-3]。PHN是带状疱疹最常见的并发症，年发病率为3.9~42.0/10万，约9%~34%的带状疱疹病人会发生PHN。且随着年龄的增加，周围神经病理性疼痛患病率呈逐渐升高的趋势[1]。 周围神经病理性疼痛表现为感觉异常、自发性疼痛、痛觉过敏和痛觉超敏。病程持续时间长，疼痛持续存在或反复发作，即使原有病因去除、损伤愈合或得到有效控制，疼痛也仍迁延持续，且常伴睡眠障碍、焦虑、抑郁等症状，给患者带来极大痛苦并造成功能障碍。目前指南推荐一线治疗药物主要为钙离子通道调节剂（例如加巴喷丁、普瑞巴林等，常见头晕、嗜睡等中枢神经系统副作用）及抗抑郁药5-羟色胺-去甲肾上腺素再摄取抑制剂（例如文拉法辛、度洛西汀）；三环类抗抑郁药和局部外用药可作为二线治疗选择；阿片类药物因成瘾性、呼吸抑制等严重风险，不推荐常规使用，仅在其他治疗方案无效时谨慎选用。 02 关于AT2R拮抗剂 AT2R（Angiotensin Ⅱ Type 2 Receptor）是肾素-血管紧张素系统（RAS）的重要受体。传统研究认为该靶点是RAS系统的替代通路及保护性通路的重要组成部分[4]，但近几年的靶点研究发现，在神经性损伤痛觉模型中，AT2R与疼痛具有显著关联[5]。 研究证实，神经损伤后，AT2R会在浸润至损伤部位的巨噬细胞特异性高表达。AT2R激活后会促使巨噬细胞释放大量活性氧/氮（ROS/RNS），这些物质作为旁分泌信使，直接激活感觉神经元末梢的TRPA1（瞬时受体电位A1）离子通道，进而引发痛觉过敏与异常疼痛。此外，AT2R的激活还可诱导p38 MAPK及ERK1/2的信号激活，进一步增强感觉神经元兴奋性和离子通道敏感性，促进炎症介质诱导的痛觉放大[6]。AT2R拮抗剂可抑制这些信号通路活化，减弱外周神经损伤及炎症所致的痛觉敏化。作为一种潜在的非阿片类镇痛药物，AT2R拮抗剂有望为周围神经病理性疼痛患者提供新的治疗选择。目前全球暂无AT2R拮抗剂药物获批上市，在研的AT2R拮抗剂中进展最快的处于临床Ⅱ期。 03 关于HW243040 HW243040片是由人福医药研究院自主研发的化药1类创新药，该药物通过拮抗AT2R受体调控疼痛传导通路。临床前研究结果显示，HW243040对AT2R受体具有较好的选择性，在多种疼痛模型中均展现出优良的镇痛效果。此外，HW243040在非临床安全性评价中表现出良好的安全窗口，为临床转化奠定了坚实基础。 HW243040片研发进程的顺利推进，将为周围神经病理性疼痛患者带来安全、有效的非阿片类靶向治疗新选择，进一步丰富该领域的临床治疗手段，助力破解周围神经病理性疼痛长期缺乏理想药物的困境。 About us 关于人福医药研究院 人福医药研究院是人福医药集团的中央研发机构，是集团创新发展的核心引擎，承载着集团战略转型使命，为构建全球研发体系、冲刺世界一流生命科技企业提供核心支撑。研究院聚焦创新药研发，以满足未被满足的临床需求为导向，在集团的优势治疗领域持续深耕，凭借强劲的自主研发与转化能力确立和巩固集团在核心细分赛道的研发优势。研究院将以患者需求为初心、科技创新为引擎，深耕生命健康领域，用优质创新药物赋能人类健康事业，助力集团打造全球竞争力。如需了解更多研发动态，欢迎关注“人福医药研究院”微信公众号。 First Patient Enrolled in Phase Ⅰ Trial of Humanwell Healthcare’s HW243040 for Peripheral Neuropathic Pain Humanwell Healthcare recently dosed the first subject in the Phase Ⅰ clinical trial of HW243040, an in-house developed angiotensin Ⅱ type 2 receptor (AT2R) antagonist, marking the initiation of first-in-human (FIH) evaluation for this investigational drug. This Phase Ⅰ, randomized, double-blind, placebo-controlled, single-center, dose-escalation clinical trial is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of HW243040 in healthy volunteers. The study is led by Professor Guoping Yang from The Third Xiangya Hospital of Central South University as the Principal Investigator (PI). 01 About Peripheral Neuropathic Pain Neuropathic pain is a chronic condition caused by a lesion or disease of the somatosensory nervous system. Based on the anatomical location of the affected site, it is categorized into peripheral and central neuropathic pain, with the peripheral form being far more prevalent in clinical practice. Among the various subtypes of peripheral neuropathic pain, painful diabetic peripheral neuropathy (PDPN) and postherpetic neuralgia (PHN) are the two most prevalent. As one of the most frequent chronic complications of diabetes, PDPN affects an estimated 8.0-26.0% of diabetic patients, with the prevalence reaching as high as 57.2% among individuals with type 2 diabetes and diabetic peripheral neuropathy. Despite this heavy burden, current clinical management continues to face significant hurdles, particularly regarding underdiagnosis and non-standardized treatment approaches[1-3]. As the most frequent complication of herpes zoster, PHN has an annual incidence rate ranging from 3.9 to 42.0 per 100,000 individuals. Approximately 9-34% of patients with herpes zoster will subsequently develop PHN. Furthermore, the prevalence of peripheral neuropathic pain is known to rise steadily with advancing age[1]. Clinically, peripheral neuropathic pain is characterized by paresthesia, spontaneous pain, hyperalgesia, and allodynia. The condition exhibits a prolonged and often intractable clinical course. Notably, the pain frequently persists or recurs long after the underlying cause has been resolved, the initial injury has healed, or the primary disease is effectively controlled. Furthermore, it is frequently accompanied by severe comorbidities such as sleep disturbances, anxiety, and depression, leading to profound functional impairment and a significantly diminished quality of life for patients. Currently, first-line therapies include serotonin-norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine, as well as calcium channel modulators (e.g., gabapentin and pregabalin). However, the clinical utility of calcium channel modulators is often limited by central nervous system (CNS) adverse events, notably dizziness and somnolence. Tricyclic antidepressants (TCAs) and topical agents serve as second-line options. Meanwhile, due to severe risk profiles—including addiction potential and respiratory depression—opioids are not recommended for routine use and are strictly reserved as a last resort for patients unresponsive to other treatments. 02 About AT2R Antagonists The angiotensin Ⅱ type 2 receptor (AT2R) is a crucial component of the renin-angiotensin system (RAS). While traditionally recognized for its role in the protective and alternative pathways of the RAS[4], emerging research has revealed a strong association between AT2R and pain signaling pathway in neuropathic pain models, highlighting its potential as a novel therapeutic target[5]. Research evidence indicates that following nerve injury, AT2R is specifically upregulated in macrophages infiltrating the injury site. Upon activation, AT2R triggers these macrophages to release abundant reactive oxygen and nitrogen species (ROS/RNS). Acting as paracrine messengers, these molecules directly activate transient receptor potential ankyrin 1 (TRPA1) ion channels on sensory nerve terminals, ultimately driving hyperalgesia and allodynia. Furthermore, AT2R activation triggers the downstream activation of p38 mitogen-activated protein kinase (p38 MAPK) and extracellular signal-regulated kinase 1/2 (ERK1/2) signaling pathways. This cascade subsequently amplifies sensory neuron excitability and ion channel sensitivity, thereby potentiating the pain signaling induced by inflammatory mediators[6]. By inhibiting these crucial signaling pathways, AT2R antagonists can effectively attenuate pain sensitization induced by peripheral nerve injury and inflammation. As a highly promising new class of nonopioid analgesics, AT2R antagonists have the potential to deliver a much-needed, novel therapeutic option for patients suffering from peripheral neuropathic pain. To date, no AT2R antagonists have received regulatory approval globally. Within the current global clinical pipeline, the most advanced investigational candidate targeting this receptor is in Phase Ⅱ studies. 03 About HW243040 HW243040 is a small‑molecule innovative drug independently developed by Humanwell Pharmaceutical R&D Institute. It is designed to modulate pain signaling pathway by selectively antagonizing AT2R. Preclinical studies demonstrate that HW243040 exhibits high selectivity for AT2R, delivering robust analgesic efficacy across multiple pain models. Furthermore, HW243040 demonstrated a highly favorable safety profile in preclinical evaluations, providing a robust foundation for its subsequent clinical development. The steady advancement of HW243040 holds the potential to deliver a safe and effective nonopioid therapy for patients suffering from peripheral neuropathic pain. Ultimately, it aims to further expand the clinical treatment landscape and address the profound, long-standing unmet medical needs in this therapeutic area. About us About Humanwell R&D Institute Humanwell Pharmaceutical Research and Development Institute is the central R&D organization of Humanwell Healthcare and the core engine driving Humanwell's innovation-led development. It undertakes Humanwell's strategic transformation mission and provides essential support for building a global R&D system and advancing toward a world-class life sciences enterprise. Focused on innovative drug development and guided by unmet clinical needs, the Institute continues to deepen its expertise in Humanwell's key therapeutic areas, leveraging strong in-house R&D and translational capabilities to establish and reinforce Humanwell's research advantages in core niche segments. With patient needs as its founding mission and technological innovation as its driving force, the Institute is committed to advancing the field of life and health sciences, empowering human health through high-quality innovative medicines, and helping Humanwell build global competitiveness. For more updates on our R&D progress, follow the official WeChat account "Humanwell Pharmaceutical Research Institute". 参考文献： [1]周围神经病理性疼痛诊疗中国专家共识[J]. 中国疼痛医学杂志,2020,26(5):321-328. [2]中国研究型医院学会头痛与感觉障碍专业委员会,于生元. 痛性糖尿病周围神经病变诊疗专家共识(2025年版)[J]. 中国疼痛医学杂志,2025,31(12):881-890. [3]中国神经病理性疼痛诊疗指南制订专家组,中国老年保健协会疼痛病学分会,程志祥,等. 中国神经病理性疼痛诊疗指南（2024版）[J]. 中华疼痛学杂志,2024,20(4):484-508. [4]Steckelings U M, Widdop R E, Sturrock E D, et al. The angiotensin AT2 receptor: from a binding site to a novel therapeutic target[J]. Pharmacological Reviews, 2022, 74(4): 1051-1135. [5]Balogh M, Aguilar C, Nguyen N T, et al. Angiotensin receptors and neuropathic pain[J]. Pain reports, 2021, 6(1): e869. [6]Smith M T. Nonopioid analgesics discovery and the Valley of Death: EMA401 from concept to clinical trial[J]. Pain, 2022, 163(S1): S15-S28. 本文转载自人福医药研究院微信公众号，如有任何问题请联系原作者