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$和誉-B(02256)$

Abbisko reported FY24 revenue of Rmb504mn and net profit of Rmb28mn. R&D expense was Rmb451mn (+4.1% yoy) in 2024, and mgmt. guided for less than US$80mn cash burn for operations in FY25 ($70m in FY24). The company had ~Rmb2.0bn cash/cash equivalents/deposits on hand by YE24. We think 2025 would be a year full of catalysts: 1) pimicotinib’s NDA submission to NMPA/FDA and potential global rights lis-out; 2) irpagratinib pivotal study launch and 1L HCC Ph2 data update; and 3) new novel candidates with best-in-class potential to enter clinical stage. We maintain our Buy/H rating on Abbisko with a new TP of HK$10 (from HK$8.5).

和誉医药报告2024财年收入为5.04亿元人民币，净利润为2800万元人民币。2024年研发费用为4.51亿元人民币，同比增长4.1%，管理层预计2025财年的运营现金消耗将少于8000万美元（2024年为7000万美元）。截至2024年底，公司持有约20亿元人民币的现金及现金等价物/存款。我们认为2025年将是充满催化剂的一年：1）pimicotinib将向中国国家药品监督管理局（NMPA）和美国食品药品监督管理局（FDA）提交新药申请（NDA），并有可能进行全球权益授权；2）irpagratinib将启动关键性研究，并更新一线肝细胞癌（HCC）治疗的二期临床数据；3）具有同类最佳潜力的新候选药物将进入临床阶段。我们维持对和誉医药的买入评级，并将目标价从8.5港元上调至10港元.

Pimicotinib NDA submission expected in mid-25 — Pimicotinib demonstrated promising efficacy and safety in global Ph3 TGCT study, and mgmt. expects to file NDA to NMPA in mid-25 and to FDA in 2H25. Pimicotinib also showed a preliminary ORR of 64% in cGvHD Ph2 study, and mgmt. will discuss with the CN/US regulators on global Ph3 study design after all patients finish 24 weeks follow-up. Given on the promising data, we expect Merck KGaA to exercise the option for pimicotinib’s global rights in 2025.

Pimicotinib预计于2025年年中递交NDA— pimicotinib在全球三期TGCT研究中表现出令人鼓舞的疗效和安全性，管理层预计将于2025年年中向NMPA提交NDA，并于2025年下半年向FDA提交。 pimicotinib在cGvHD二期研究中也显示出64%的初步客观缓解率（ORR），管理层将在所有患者完成24周随访后与中美监管机构讨论全球三期研究设计。鉴于这些令人鼓舞的数据，我们预计默克集团将于2025年行使pimicotinib的全球权益。

Irpagratinib to launch pivotal study in mid-25 — Based on the data of irpagratinib in 2L HCC - 44.8% ORR and 5.5 mPFS in prior ICI & mTKI treated patients in 220mg BID cohort, NMPA has agreed on the pivotal trial for irpagratinib. The pivotal Ph3 study will enroll ~140 pts (irpagratinib:SoC 1:1) with ORR as the primary endpoint, and the trial will be launched in mid-25. Also further data for irpagratinib+ atezolizumab in 1L HCC will be in 2Q25 (previously reported ORR of ~50% in ESMO GI 2024).

Irpagratinib将于2025年年中启动关键性研究—基于irpagratinib在二线HCC中的数据——在220mg BID组中，先前接受过ICI和mTKI治疗的患者的ORR为44.8%，中位无进展生存期（mPFS）为5.5个月，NMPA已同意irpagratinib的关键性临床试验。关键性三期研究将招募约140名患者（irpagratinib：标准治疗=1:1），以ORR为主要终点，试验将于2025年年中启动。此外，irpagratinib联合atezolizumab在一线HCC中的进一步数据将于2025年第二季度公布（此前在2024年ESMO GI大会上报告的ORR约为50%）。

Early pipeline candidates to provide further growth — ABSK043 (oral smallmolecule PD-L1 inhibitor) Ph1 data was updated in ESMO with positive efficacy signals in EGFRm NSCLC. ABSK061 (FGFR2/3 inhibitor) preliminary data in solid tumors was presented in ESMO-TAT 2024, and Ph1 study for achondroplasia (ACH) will be launched in 2Q25. ABSK131 (PRMT5*MTA) Ph1 trial will launch in 3Q25. ABSK141 (KRAS G12D) has best-in-class oral bioavailability and IND submission is expected in 3Q25. Also, a pan-KRAS project is on track for PCC nomination in 1H25.

早期管线候选药物将提供进一步增长—ABSK043（口服小分子PD-L1抑制剂）一期数据在ESMO上更新，在EGFR突变的非小细胞肺癌治疗（NSCLC）中显示出积极的疗效信号。ABSK061（FGFR2/3抑制剂）在实体瘤中的初步数据已在2024年ESMO-TAT大会上展示，针对软骨发育不全（ACH）的一期研究将于2025年第二季度启动。ABSK131（PRMT5*MTA）的一期试验将于2025年第三季度启动。ABSK141（KRAS G12D抑制剂）在多种物种中表现出卓越的口服生物利用度，计划于2025年第三季度提交临床试验申请（IND）。此外，针对多种KRAS突变的项目预计将在2025年上半年确定临床候选化合物（PCC）。

Implications —We included the clinical-stage assets ABSK043 and ABSK061 in our latest model, deriving a new TP to HK$10 (from HK$8.5). We think currently the global potential of pimicotinib is still undervalued, maintain Buy/1H rating.

结论—我们在最新模型中纳入了临床阶段的ABSK043和ABSK061，将目标价从8.5港元上调至10港元。我们认为，目前市场仍低估了pimicotinib的全球潜力，维持买入评级。

$和誉-B(02256)$