Pimicotinib Hydrochloride

Solid first-quarter performance driven by Process Solutions and Semiconductor Materials Strong foreign exchange effects remain a headwind Group net sales of € 5.1 billion (organic growth +2.9%) EBITDA pre of € 1.5 billion (organic growth +5.3%) Company upgrades full-year 2026 guidance Building from a position of strength, the Group sharpens its strategic direction to create mid- to long-term value and growth – and confirms its mid-term guidance Merck KGaA, Darmstadt, Germany, a leading science and technology company, delivered a solid start to fiscal 2026. In the first quarter, the Group generated moderate organic sales growth and sustained profitability. This was driven by Process Solutions and Semiconductor Materials, while strong foreign exchange effects continued to weigh on reported figures. “Our first-quarter performance underlines the strength of the company’s diversified portfolio and its clear focus on complementary science and technology businesses,” said Kai Beckmann, Chairman of the Executive Board and Group CEO of Merck KGaA, Darmstadt, Germany, since May 1. “Based on our performance in the first quarter and our current market conditions, we upgrade our full-year 2026 financial guidance. At the same time, we sharpen the strategic direction of the company for the long-term. As markets, technologies and customer needs evolve, we will adapt our operating model and move towards a stronger focus on integrated workflow solutions for customers, expanding our offerings for customers and patients and bundling capabilities across our businesses.” First-quarter results In the first quarter of 2026, reported Group net sales reached € 5.1 billion (Q1 2025: € 5.3 billion). Despite organic growth of 2.9% compared with the year-earlier quarter, strong foreign exchange effects had an impact of –5.5%, resulting in a 2.8% decline in reported net sales. EBITDA pre grew by 5.3% organically and amounted to € 1.5 billion (Q1 2025: € 1.5 billion), with foreign exchange effects of –5.7%. This corresponds to an improved EBITDA pre margin of 29.8% (Q1 2025: 29.1%), supported by one-time effects in the Electronics business sector. Earnings per share pre came in at € 2.11, in line with the year-earlier quarter (Q1 2025: € 2.12). The development reflects disciplined cost management and differing contributions from all three business sectors, offset by negative foreign exchange effects. Group performance shaped by solid demand In the first quarter of 2026, Merck KGaA, Darmstadt, Germany, recorded solid demand across its portfolio. Despite ongoing macroeconomic uncertainty and geopolitical tensions, this development reflects resilience in the company’s attractive growth markets. Demand trends varied across regions and applications, underscoring the value of the Group’s diversified business model and global footprint. Foreign exchange effects significantly weighed on reported sales and earnings at Group level, driven primarily by the development of the U.S. dollar against the euro as well as foreign exchange effects in key Asian markets. These effects are in line with the assumptions underlying the company’s guidance for the year. Life Science benefits from growth across the business with innovation at its core Life Science delivered a strong start to 2026, with organic growth across the business led by Process Solutions. The performance reflected the business sector’s breadth across research, development, manufacturing, and regulated applications, as well as a sharpened focus on operational effectiveness. Effective January 1, 2026, a new go-to-market model aligned the organization more closely with customer needs and purchasing journeys through three distinct business units: Process Solutions, Discovery Solutions and Advanced Solutions. Net sales of Life Science grew by 2.2% to € 2.3 billion. Strong organic growth of 8.3% overcame foreign exchange effects of –6.0%. EBITDA pre was € 649 million, an increase of 4.2% year-on-year. Organic growth of 7.4% and portfolio effects of 1.6% surpassed foreign exchange effects of –4.8%. Process Solutions, which offers solutions for every step of pharmaceutical manufacturing, remained the growth driver in the first quarter. Net sales grew organically by 16.2% and surpassed the threshold of € 1 billion. Growth was supported by strong momentum in downstream processing and single-use solutions, alongside limited safety stock building in response to regional developments as well as contributions from new customer projects. Order intake remained strong across the portfolio. On March 31, 2026, Life Science also closed the acquisition of JSR Life Sciences’ chromatography business. These technologies help improve productivity and support scalable biologics manufacturing. Discovery Solutions, with its digital-first portfolio of biology and chemistry products for research and early-stage workflows, grew organically by 1.6%. Due to foreign exchange effects, net sales declined to € 692 million. The business unit’s performance was supported by continued demand from academic, biotech and pharmaceutical customers in a gradually improving research spending environment. Advanced Solutions saw organic growth of 4.0%. However, foreign exchange effects and a small portfolio effect led to an overall decline of 2.7% to € 563 million. The business unit delivers tailored products and services that help customers address unique needs in high-touch and regulated environments. Performance was supported by demand for key solutions across the portfolio in quality-critical end markets such as diagnostics, testing and regulated manufacturing. Life Science continued to increase its investment in R&D, expanding its portfolio with solutions for improved performance across research and biopharmaceutical manufacturing. Recent launches include the digitally enabled Milli-Q® CLX 8Series systems, which enable clinical labs to target 99.9% uptime of high-quality purified water. The FemtoQuest™ system enhances capabilities for ultrasensitive biomarker detection with up to 1,000 times greater sensitivity than traditional methods. Furthermore, Millipore Express® Ace supports more efficient and sustainable sterilizing-grade filtration, underlining the company’s commitment to bringing greener alternatives to the market. These innovations help customers improve efficiency and performance across crucial research and manufacturing workflows. Healthcare delivers stable performance amid portfolio dynamics Sales in Healthcare were supported by treatments addressing rare diseases and cardiovascular, metabolic and endocrine diseases, while pricing and lifecycle effects continued to impact mature franchises. The business sector delivered net sales of € 2.1 billion and EBITDA pre of € 718 million in the first quarter of 2026. Overall, net sales declined organically by 3.4%. Positive portfolio effects added 4.4 percentage points, while foreign exchange effects had an impact of –4.0%. EBITDA pre was down 9.7% year-on-year, due mainly to foreign exchange effects of –8.5% and follow-on costs associated with the acquisition of SpringWorks Therapeutics Inc., USA, in 2025. The Rare Diseases franchise contributed significantly to the results, reflected as a portfolio effect of 4.4%. Net sales mainly include Ogsiveo®, which treats progressing desmoid tumors, and Gomekli®, approved for neurofibromatosis type 1. Following approval in China for the treatment of tenosynovial giant cell tumor (TGCT), pimicotinib has had an encouraging start and recorded its first sales in the first quarter of 2026. The Cardiovascular, Metabolism & Endocrinology franchise grew by 1.2% organically against a tough comparative base in the year-earlier quarter. Main drivers were the diabetes medicine Glucophage® with organic growth of 6.3% and the thyroid medicine Euthyrox®, which grew by 5.8% organically. In the Fertility franchise, Pergoveris®, indicated for the stimulation of follicular development in women, grew organically by 19.5% across all regions. This was more than offset by the organic decline of Gonal-f®, a follicle-stimulating hormone treatment, amid remaining net price effects in the United States. Net sales of the Oncology franchise declined organically by 4.9% compared with the year-earlier quarter. Erbitux®, a treatment for metastatic colorectal cancer and for cancer of the head and neck, saw an organic decline of 3.3% due to competition from non-comparable biologics in China. Bavencio®, which is used to treat locally advanced or metastatic urothelial carcinoma, declined organically by 13.5% amid increasing competition. In the Neurology & Immunology (N&I) franchise, Mavenclad®, indicated for relapsing forms of multiple sclerosis, saw an organic decline of 6.8% due to weaker demand in North America following the loss of market exclusivity in the United States. By contrast, organic sales continued to grow in Europe, the Middle East and Africa, and Latin America. Healthcare continues to focus on strengthening its position in rare diseases, advancing its pipeline through both internal and external innovation, and building its portfolio for sustainable profitable growth. Recent progress includes the first patient dosed in the Phase III program, ELOWEN‑1 (NCT07332481) and ELOWEN‑2 (NCT07355218), evaluating enpatoran in people living with lupus who experience active skin manifestations. In addition, ongoing regulatory filings include pimicotinib in the United States and Europe; and the company is filing Pergoveris® for review under the U.S. FDA Commissioner's National Priority Voucher (CNPV) program. Electronics supported by structural semiconductor trends Electronics recorded continued solid performance in the first quarter of 2026, with net sales of € 817 million and EBITDA pre of € 282 million. Demand was supported by advanced semiconductor applications, including materials used in artificial intelligence and high‑performance computing. Net sales grew organically by 4.2%. Due to portfolio effects of –10.6% and foreign exchange effects of –7.5%, reported net sales were lower year-on-year. EBITDA pre increased by 30.1% organically. This strong growth was driven by one-time effects from a reimbursement reflecting the recovery of costs incurred in connection with a non-quality-related supplier mislabeling dispute as well as the sale of OLED patents to Universal Display Corporation, USA. Foreign exchange effects had an impact of –‍9.2% and portfolio effects of –5.4%. Semiconductor Solutions achieved strong organic growth of 7.5%. However, net sales declined slightly to € 640 million due to foreign exchange effects of –9.1%. Semiconductor Materials grew organically in the low-teens percentage range on the back of continued demand for high-value materials for AI chip systems and advanced nodes. Advanced nodes are the latest semiconductor manufacturing processes that enable smaller feature sizes and the most powerful chips. Net sales in Delivery Systems & Services (DS&S) declined compared with the year-earlier quarter but stabilized sequentially. Net sales in Optronics were € 177 million. The Metrology & Inspection business, which provides equipment for semiconductor and optoelectronic manufacturing, grew organically in the mid-double-digit percentage range. The businesses with liquid crystals, photoresists for display applications and OLED materials declined organically due to lower demand. Merck KGaA, Darmstadt, Germany, offers one of the broadest portfolios of materials and material-related tools and equipment for the semiconductor industry. With its system know-how, the Electronics business sector is driving the convergence of optics and semiconductors to meet the demands of next-generation technologies for advanced chip systems. These tools are crucial for highly accurate wafer measurements, enabling process control and defect detection to enhance production yields and accelerate time-to-market. The company's integrated semiconductor solutions are enabling faster, smarter and more energy-efficient devices. Positioning Merck KGaA, Darmstadt, Germany, for evolving markets and future growth opportunities Against a dynamic market backdrop, Merck KGaA, Darmstadt, Germany, is sharpening its strategic direction to strengthen resilience and capture future growth opportunities. Building on its established positions across attractive markets and along the value chain, the company is continuing to align its portfolio, innovation priorities and operating model with areas of highest long-term value creation. This includes the continued development of differentiated, high-growth businesses and a stronger focus on integrated solutions across customer processes. It includes the increased use of platformed capabilities and AI to enhance speed, scalability and execution across the enterprise, and a disciplined approach to external innovation through partnerships, in-licensing and selective acquisitions. Through this approach, Merck KGaA, Darmstadt, Germany, aims to further strengthen its competitive position while advancing the foundations for sustainable, profitable growth over time. At the same time, the company confirms its mid-term guidance, while the multi-year measures outlined today are expected to be implemented progressively and to strengthen the foundation for higher long-term growth while sustaining attractive margins. Kai Beckmann, Chairman of the Executive Board and Group CEO of Merck KGaA, Darmstadt, Germany, said: “Merck KGaA, Darmstadt, Germany, is operating from a position of strength, building on more than 350 years of science-driven innovation. Our unique expertise in biology, chemistry, and physics enables us to play a leading role in translating the digital world into the real world. From the laboratory to our customers and patients, we are active along the entire industrial value chain. Our strategic direction aims to increase focus across our diversified portfolio, strengthen the company’s innovation engine and enhance the scalability of its operating model. This will enable us to respond to changing market conditions, increase implementation speed, flexibility and scalability, and drive growth and sustainable value over the long term.” Guidance for 2026 Based on the Group’s performance in the first quarter and current market conditions, Merck KGaA, Darmstadt, Germany, has upgraded the target corridors for its full‑year 2026 guidance. The company now expects net sales between € 20.4 billion and € 21.4 billion and EBITDA pre between € 5.7 billion and € 6.1 billion. This adjustment primarily reflects assumptions of stronger momentum in Life Science and Healthcare's resilience in a challenging environment. The guidance assumes no sales of Mavenclad® in the United Sates from May 2026 (previous forecast: from March 2026) amid generic competition and furthermore excludes the potential commercialization of Pergoveris® in the United States. As a result, the implied organic growth corridor for Group net sales shifts to 0% to +3%. Organic EBITDA pre growth is now expected at –2% to +2%. The company anticipates foreign exchange effects to impact net sales between –3% to –1%; for EBITDA pre, the range is –5% to –2%. This translates to an EPS pre between € 7.50 and € 8.20. At the same time, the company confirms its previous mid-term guidance. Merck KGaA, Darmstadt, Germany, targets annual organic sales growth in the mid-single-digit percentage range. For the EBITDA pre margin, the company sees potential for a step-up to approximately 30%, while the multi-year measures outlined today are expected to be implemented progressively and to strengthen the foundation for higher long-term growth while sustaining attractive margins. Overview of the key figures for Q1 2026 Merck KGaA, Darmstadt, Germany Key figures € million Q1 2026 Q1 2025 Change Net sales 5,134 5,280 -2.8% Operating result (EBIT)1 937 1,006 -6.8% Margin (% of net sales)1 18.3% 19.0% EBITDA2 1,434 1,479 -3.0% Margin (% of net sales)1 27.9% 28.0% EBITDA pre1 1,530 1,535 -0.3% Margin (% of net sales)1 29.8% 29.1% Profit after income tax 669 738 -9.4% Earnings per share (€) 1.52 1.69 -10.1% Earnings per share pre (€)1 2.11 2.12 -0.5% Operating cash flow 818 556 47.2% Net financial debt1, 3 8,318 8,619 -3.5% Number of employees4 62,477 62,604 -0.2% 1 Not defined by IFRS® Accounting Standards (IFRS Accounting Standards). 2 Not defined by IFRS Accounting Standards; EBITDA corresponds to operating result (EBIT) adjusted by depreciation, amortization, impairment losses, and reversals of impairment losses. 3 Figures for the reporting period ending on March 31, 2026, prior-year figures as of December 31, 2025. Life Science Net sales by business unit € million Q1 2026 Share Organic growth1 Exchange rate effects1 Acquisitions/ divestments1 Total change Q1 20252 Share Process Solutions 1,011 45% 16.2% -6.1% – -10.1% 919 41% Discovery Solutions 692 30% 1.6% -5.6% – -4.0% 721 33% Advanced Solutions 563 25% 4.0% -6.2% -0.5% -2.7% 578 26% Life Science 2,266 100% 8.3% -6.0% -0.1% 2.2% 2,218 100% 1 Not defined by IFRS Accounting Standards. 2 Prior-year figures have been adjusted to reflect the transformation of the three business units. Forecast for the Group Forecast for FY 2026 € million Net sales EBITDA pre1 Free cash flow Group ~20,400 to 21,400 Organic 0% to +3% Foreign exchange effect -3% to -1% Portfolio ~0% ~5,700 to 6,100 Organic -2% to +2% Foreign exchange effect -5% to -2% Portfolio ~0% ~1,600 to 2,100 Life Science ~9,100 to 9,500 Organic +4% to +7% Foreign exchange effect -3% to -1% Portfolio ~0% ~2,600 to 2,800 Organic +4% to +8% Foreign exchange effect -4% to -1% Portfolio ~+1% n/a Healthcare ~8,100 to 8,500 Organic -6% to -3% Foreign exchange effect -3% to 0% Portfolio ~+2% ~2,600 to 2,800 Organic -12% to -8% Foreign exchange effect -5% to -2% Portfolio ~0% n/a Electronics ~3,200 to 3,400 Organic +3% to +7% Foreign exchange effect -4% to -2% Portfolio ~-7% ~900 to 1,000 Organic +21% to +27% Foreign exchange effect -4% to -1% Portfolio ~-4% n/a Corporate and Other n/a ~-450 n/a Notes to editors: The press conference for media representatives will take place at 9:30 a.m. (CEST). The respective presentation and further information for journalists, including a digital press kit, can be found here. The quarterly statement can be found here. Merck KGaA, Darmstadt, Germany, on LinkedIn. Company photos and videos can be found here. Merck KGaA, Darmstadt, Germany, stock symbols: Reuters: MRCG, Bloomberg: MRK GY, Dow Jones: MRK.DE Frankfurt Stock Exchange: ISIN: DE 000 659 9905 – WKN: 659 990

力胜克拉片（Lisaftoclax，APG-2575）是中国首个申报上市的原研Bcl-2抑制剂、全球第二款Bcl-2抑制剂，由亚盛医药自主研发。 基本信息 通用名：力胜克拉片 研发代码：APG-2575 英文名：Lisaftoclax 靶点：Bcl-2（B细胞淋巴瘤因子2） 机制：选择性抑制 Bcl-2，恢复肿瘤细胞凋亡通路，诱导癌细胞死亡。 申报状态：2024-11-16 NDA 获CDE受理并纳入优先审评，适应症为复发/难治性 CLL/SLL。 孤儿药资格：获 FDA 5 项孤儿药资格（CLL、WM、MM、AML、FL）。 关键差异化（vs 维奈克拉） 半衰期：3–4小时（维奈克拉约26小时），无明显药物相互作用（DDI）。 肿瘤溶解综合征（TLS）：风险更低，剂量爬坡更快（约1周完成），耐受性更好。 疗效：单药ORR约73.3%；联合BTK抑制剂（如阿可替尼）ORR达96.6%–98%，初治可达100%。 指南地位：2025年纳入CSCO淋巴瘤指南，唯一国产原研Bcl-2抑制剂推荐。 核心适应症（申报/在研） 已申报：复发/难治性慢性淋巴细胞白血病（CLL）/小淋巴细胞淋巴瘤（SLL）。 在研关键适应症： 联合阿扎胞苷一线治疗MDS/CMML（III 期，ORR 80%，CR 40%）。 多发性骨髓瘤（MM）、急性髓系白血病（AML）、滤泡性淋巴瘤（FL）、华氏巨球蛋白血症（WM）。 临床数据要点（CLL/SLL） 单药（1b/2 期）：n=47，ORR 73.3%，CR/CRi 24.4%，1 年 OS 率 94.8%。 联合阿可替尼：n=87，ORR 96.6%，12个月 PFS 率 89%。 上市情况 力胜克拉片（Lisaftoclax，APG-2575）已正式获批上市（全球第2款、国产首款 Bcl-2 抑制剂）。 中国获批情况 2024-11-16：NDA获CDE受理并纳入优先审评（适应症：r/r CLL/SLL）。 2025-07-10：NMPA正式批准上市，通用名：利沙托克拉片（曾用名：力胜克拉片）。 获批适应症：既往经至少含BTK抑制剂的一种系统治疗的成人r/r CLL/SLL。 获批依据：中国关键注册II期（APG2575CC201），单药ORR 73.3%，CR/CRi 24.4%。 商品名/通用名 通用名：利沙托克拉片（Lisaftoclax） 曾用名：力胜克拉片 研发代码：APG-2575 全球进展 中国：已上市（2025-07-10）。 美国/欧盟：未上市，处于关键临床III期，FDA已授予5项孤儿药资格（CLL、WM、MM、AML、FL）。 国内竞争格局 利沙托克拉（亚盛）：2025-07-10获批，首款国产Bcl-2。 索托克拉（百济）：2025-04 NDA受理，优先审评，待获批。 专利情况 全球专利壁垒稳固，中国已扫清维奈克拉专利障碍，核心化合物专利至2037 年到期，覆盖全球主要市场。 核心化合物专利 专利家族：WO2018027097A1（PCT）、CN201780035965.5（中国母案）、CN201910626474.X（分案） 申请日：2017-08-04（优先权日） 授权状态：中国、美国、欧洲、日本等全球主要市场均已授权 保护期限：自申请日起 20 年，至 2037-08-04到期 核心专利源：密歇根大学（发明人：杨大俊、王少萌），亚盛医药独家全球许可 专利布局（全球/中国） 覆盖化合物、晶型、制剂、工艺、适应症 / 联合用药全链条，构筑严密壁垒： 化合物专利：核心结构专利，全球授权，无重叠维奈克拉核心结构 晶型专利：多晶型及制备工艺，延长保护至 2038 年后 制剂/处方专利：片剂、缓释制剂等，覆盖给药形式 合成工艺专利：关键中间体、路线优化，保护生产技术 用途/联合用药专利：CLL/SLL、MDS、AML等适应症，联合BTK/阿扎胞苷方案。 与维奈克拉（艾伯维）的专利冲突（中国关键突破） 艾伯维专利：维奈克拉中国分案201510165051.4（051 专利），2017-06 授权，曾过度扩大马库什范围，试图覆盖利沙托克拉结构。 亚盛挑战（2021—2022）： 2021-07：首次无效，权利要求 3 被无效 2022-11：二次无效，核心权利要求 1 被无效，彻底扫清中国上市障碍 美国 / 欧洲：艾伯维仅保护维奈克拉具体化合物，不覆盖利沙托克拉，无专利纠纷风险 专利风险与到期时间线 中国：核心专利2037-08到期；晶型/制剂专利2038—2040到期，独占期长； 美国/欧洲：核心专利2037年到期；无维奈克拉专利阻碍； 仿制药威胁：2037年前无合法仿制药；晶型/制剂专利进一步延后仿制至2040年后。 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α₂肾上腺素受体激动剂舌下膜剂 【药品分享】卡匹色替片——全球首个获批上市的AKT抑制剂 【药品分享】库莫西利胶囊——全球首个CDK2/4/6抑制剂 【药品分享】赛贝曲司他片——全球首个HAE急性发作口服疗法 【药品分享】KYGEVVI（Doxecitine/Doxribtimine）——全球首款且唯一获批的TK2d针对性治疗药物 【药品分享】Forzinity（Elamipretide）注射剂——全球首个用于治疗Barth综合征的药物 【药品分享】Brinsupri（Brensocatib, 布伦索卡替布）片——全球首个获批上市的二肽基肽酶1（DPP-1）抑制剂 【药品分享】维立西呱片——全球首个心衰适应症的可溶性鸟苷酸环化酶（sGC）刺激剂 【药品分享】盐酸哌罗匹隆片——非典型抗精神病药 【药品分享】盐酸托泊替康胶囊/注射用盐酸托泊替康——经典的拓扑异构酶Ⅰ抑制剂类抗肿瘤药 【药品分享】阿普昔腾坦片——全球首个获批用于难治性高血压的口服双重内皮素受体拮抗剂（ERA） 【药品分享】注射用盐酸依拉环素——全球首个氟环素类抗生素 【药品分享】奥洛格列净胶囊——国内首款抑制SGLT1与SGLT2的1类创新药 【药品分享】盐酸匹米替尼胶囊——国内首个、全球首个获批的腱鞘巨细胞瘤（TGCT）系统性靶向药，高选择性CSF-1R抑制剂 【药品分享】布地奈德肠溶胶囊——全球首个、中国唯一获批用于原发性IgA肾病对因治疗的靶向药物 【药品分享】艾拉莫德片——中国原研、全球首个上市的小分子抗风湿药（csDMARD） 【药品分享】索托克拉片——新一代BCL2抑制剂 【药品分享】利奈昔巴特片——口服、选择性、可逆性回肠胆汁酸转运体（IBAT/ASBT）抑制剂 【药品分享】多替诺雷片——高选择性URAT1抑制剂 【药品分享】瑞普泊肽片——口服GLP‑1/GIP双靶点激动剂 【药品分享】硫酸索西美雷塞片——口服、强效的KRAS G12C共价抑制剂 【药品分享】罗伐昔替尼片——全球首创JAK/ROCK双靶点口服小分子抑制剂 【药品分享】埃诺格鲁肽注射液——全球首个获批上市的cAMP偏向型长效GLP-1受体激动剂 【药品分享】维培那肽注射液——长效GLP-1受体激动剂 【药品分享】普乐司兰钠注射液——全球首个靶向APOC3 mRNA的siRNA降脂药 【药品分享】玛仕度肽注射液——全球首个GCG/GLP-1双激动剂 【药品分享】瑞米布替尼片——全球首个获批用于CSU的口服靶向药 【药品分享】溴莫尼定噻吗洛尔滴眼液——α₂受体激动剂与非选择性 β 受体阻滞剂组成的复方降眼压药 【药品分享】吡洛西利片——国内首个CDK2/4/6多靶点抑制剂 【药品分享】奥氟格列隆片（Orforglipron） ——中国首个、全球首批上市的口服小分子 GLP-1受体激动剂 【药品分享】Copper Histidine注射液（Zycubo）——全球首个、唯一用于治疗儿童门克斯病（Menkes disease）的铜替代注射剂 【药品分享】依来格列隆片（Elecoglipron）——口服小分子非肽类GLP-1受体激动剂 【药品分享】阿利奈普仑（Aleniglipron）——口服小分子、非肽类、偏向性GLP-1受体激动剂 【药品分享】甲磺酸阿美替尼片——中国首个原研三代EGFR酪氨酸激酶抑制剂（TKI） 【药品分享】甲磺酸达麦利替尼片——口服高选择性c-MET酪氨酸激酶抑制剂 【药品分享】盐酸Acoramidis片——转甲状腺素蛋白（TTR）稳定剂 【药品分享】阿莫西林伏诺拉生胃漂浮片——3D打印胃漂浮片 【药品分享】盐酸伊可白滞素片——全球首创口服IL‑23受体拮抗剂 【药品分享】马来酸吡咯替尼片——中国首个自研的HER1/HER2/HER4不可逆酪氨酸激酶抑制剂（TKI） 【药品分享】本维莫德乳膏——全球首创芳香烃受体（AhR）调节剂（TAMA）类皮肤病外用药 【药品分享】盐酸莫托咪酯注射液——化药1类静脉麻醉新药 【药品分享】注射用罗哌卡因微晶——长效缓释局部麻醉药 【药品分享】盐酸伊立替康脂质体注射液——一款针对吉西他滨治疗失败的转移性胰腺癌的二线标准脂质体化疗药 【药品分享】甲磺酸氟马替尼片——Bcr-Abl酪氨酸激酶选择性抑制剂 【药品分享】注射用阿加糖酶β——国内获批的首个用于治疗法布雷病的药物 【药品分享】甲苯磺酸尼拉帕利胶囊——高选择性PARP1/2抑制剂 【药品分享】帕米帕利胶囊——强效、选择性PARP1/2抑制剂 【药品分享】苯环喹溴铵鼻喷雾剂——选择性M胆碱能受体拮抗剂 【药品分享】注射用拉罗尼酶浓溶液——MPS Ⅰ型的特异性酶替代治疗药物 【药品分享】海博麦布片——国产自主原研的胆固醇吸收抑制剂 【药品分享】盐酸可洛派韦胶囊——直接抗病毒药物（DAA）→ NS5A抑制剂 【药品分享】克拉考特酮乳膏——外用、非甾体、选择性雄激素受体（AR）抑制剂 【药品分享】非卢替尼片——全球首个用于多发性硬化的口服BTK抑制剂 【药品分享】Brenipatide注射液——GLP-1R/GIPR双受体激动剂（继替尔泊肽之后的第二款） 【药品分享】罗赛促红素α注射液——国产首个长效重组促红细胞生成素（EPO）创新药 【药品分享】贝组替凡片——全球首个口服小分子HIF-2α抑制剂 【药品分享】那米司特片——口服选择性PDE4B抑制剂 【药品分享】富马酸立康可泮胶囊——一款针对罕见病PNH的口服补体B因子抑制剂 【药品分享】醋酸索乐匹尼布片——高选择性脾酪氨酸激酶（Syk）抑制剂 【药品分享】甲磺酸艾多替尼片——全球首款专为肺癌脑转移设计的第三代EGFR-TKI 【药品分享】安瑞克芬注射液——全球首个获批镇痛适应症的高选择性外周κ-阿片受体（KOR）激动剂 【药品分享】Difelikefalin注射液——全球首个获批的外周选择性κ-阿片受体（KOR）激动剂 【药品分享】Obefazimod——口服、靶向 CBC、特异性增强miR-124的首创小分子 【药品分享】拉尼兰诺片——口服泛PPAR激动剂 【药品分享】舒洛地特注射液——抗血栓药、血管保护剂 【药品分享】贝普若韦生注射液——反义寡核苷酸（ASO）类乙肝新药 【药品分享】氨酚右敏口服溶液（奥肯能®）——中国内地唯一获批的氨酚右敏口服溶液 【药品分享】佩玛贝特片——新型过氧化物酶体增殖物激活受体α/δ双重激动剂 (PPARα/δ) 【药品分享】盐酸依匹斯汀乳膏——外用第二代非镇静抗组胺抗过敏药膏 【药品分享】注射用双羟萘酸帕瑞肽微球——一款用于治疗肢端肥大症的第二代长效生长抑素类似物（SRL）微球制剂 【药品分享】埃拉菲布拉诺片——治疗原发性胆汁性胆管炎（PBC）的口服靶向新药 【药品分享】泽卢克布仑钠注射液——新一代皮下注射型C5补体抑制剂 【药品分享】依达拉奉右莰醇注射用浓溶液——一款复方神经保护类注射剂 【药品分享】醋酸戈那瑞林注射液——促性腺激素释放激素（GnRH）类药物 【药品分享】甲磺酸贝舒地尔片——全球首个选择性ROCK2激酶抑制剂 【药品分享】伊托法替布软膏——外用JAK抑制剂（JAK1/JAK3） 【药品分享】注射用华卟啉钠——新型肿瘤光动力治疗（PDT）专用光敏剂 【药品分享】优替德隆胶囊——口服埃博霉素类微管抑制剂 【药品分享】艾普美妥司他片——EZH1/2双靶创新药 【药品分享】精氨酸艾曲莫德片——新型选择性鞘氨醇1-磷酸受体（S1P₁）调节剂 【药品分享】磷酸芦可替尼乳膏——全球/国内首款、唯一获批用于非节段型白癜风复色的外用JAK1/JAK2选择性抑制剂 【药品分享】盐酸右哌甲酯缓释胶囊——治疗6岁及以上注意缺陷多动障碍（ADHD）的一线药物 【药品分享】抗菌肽PL-3301口腔凝胶——中国首创的抗菌肽类抗口腔真菌感染药物 【药品分享】Zasocitinib (TAK-279) 胶囊——新一代高选择性口服 TYK2 抑制剂 【药品分享】注射用Abelacimab——一款全人源IgG1单克隆抗体，靶向凝血因子XI（FXI） 【药品分享】Duvakitug注射液——首创性人源化IgG1-λ2单克隆抗体，靶向TL1A（TNFSF15） 【药品分享】醋酸氟轻松/氢醌/维A酸乳膏——治疗中重度黄褐斑疗效明确的外用复方 【药品分享】富马酸伏诺拉生氯化钠注射液——钾离子竞争性酸阻滞剂（P‑CAB）||东阳光药业研发的2.2,2.4类改良新型新药 【药品分享】盐酸阿曲生坦片——诺华研发的高选择性内皮素 A（ETA）受体拮抗剂||中国首个获批用于IgA 肾病的非免疫性口服靶向药 【药品分享】RGT-274-CR胶囊——上海齐鲁锐格医药研发的口服小分子GLP-1受体激动剂 【药品分享】酒石酸西尼必利片——高选择性5-HT₄受体激动剂类胃肠动力药 【药品分享】石杉碱甲控释片——采用双相控释/渗透泵技术的2.2类改良型新药 【药品分享】塞伐艾替尼片——口服、可逆、选择性酪氨酸激酶抑制剂（TKI） 【药品分享】Admilparant片——口服小分子LPA₁受体拮抗剂 【药品分享】瑞拉可兰胶囊——全球首个选择性糖皮质激素受体（GR）拮抗剂 【药品分享】盐酸依特卡肽注射液——全球首个、国内唯一获批的静脉注射型拟钙剂 【药品分享】Avacincaptad pegol玻璃体内注射液——全球首批用于AMD继发地图样萎缩（GA）的靶向药物 【药品分享】盐酸达利雷生片——新一代非管制、非苯二氮䓬类抗失眠药物 【药品分享】甲磺酸瑞索利塞片——高选择性PI3Kα小分子靶向抑制剂 || 全球首个获批用于特定卵巢癌的靶向新药 【药品分享】富马酸西他沙星注射液——新型喹诺酮类抗菌药物 【药品分享】Icotrokinra——全球首个获批的口服 IL-23 受体（IL-23R）选择性拮抗多肽 【药品分享】氘可来昔替尼片（Deucravacitinib）——全球首个口服、选择性 TYK2 变构抑制剂 【药品分享】柯美奇拜单抗注射液——鼻用糖皮质激素治疗后症状控制不佳的成人中重度季节性过敏性鼻炎患者的福音 【药品分享】吉诺昔替尼——口服小分子JAK1/TYK2双重抑制剂 【药品分享】洛替拉纳（Lotilaner）——GABA 门控氯离子通道非竞争性拮抗剂 || 兼具兽医驱虫与人用眼科两大用途 【药品分享】CagriSema——由卡格列肽（cagrilintide）2.4 mg与司美格鲁肽（semaglutide）2.4 mg组成的强效减重复方药 【药品分享】苹果酸卡博替尼——口服、多靶点酪氨酸激酶抑制剂（TKI） 【药品分享】迪高替尼（Delgocitinib）——一款外用泛JAK抑制剂 【药品分享】拉氟莫司(Laflunimus)——口服免疫抑制剂 || 兼具免疫抑制与抗炎双重活性 【药品分享】伏昔尼布片——全球首个IDH1/IDH2双重突变抑制剂靶向药 【药品分享】盐酸奥昔布宁片——M受体抗胆碱药 【药品分享】贝泽昔替尼片——国内首款获批的高选择性JAK2单靶点抑制剂 【药品分享】苯甲酸安达艾替尼胶囊——新型小分子酪氨酸激酶不可逆抑制剂（EGFR-TKI） 【药品分享】伏欣奇拜单抗注射液——全人源抗IL‑1β单克隆抗体 || 用于急性痛风性关节炎的1类创新生物药 【药品分享】利多卡因丁卡因乳膏 【药品分享】伐米奇拜单抗注射液——玻璃体内注射用抗IL-6人源化单抗 【药品分享】依赛弗酶α注射液（Efzimfotase alfa 注射液）——第二代重组组织非特异性碱性磷酸酶（TNSALP）酶替代疗法 【药品分享】格达托利西布（Gedatolisib）——first‑in-class 泛 PI3K/mTORC1/2 双重抑制剂 免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。