核心观点 12 月31 日，公司宣布就ZG006 与艾伯维达成深度全球合作，首付款1 亿美元，交易总包为12.35 亿美 元。此前在ESMO Asia会议中，ZG006 已经初步展现出了在SCLC 适应症中优异的临床缓解率和良好的 持续缓解能力，我们认为公司此次与艾伯维的合作将有望进一步加速推进ZG006 在海外肿瘤适应症上 的推进，最大化的实现产品管线价值，整体看，公司未来发展可期。 事件 12 月31 日，公司发布公告，与艾伯维就ZG006 的开发和商业化权益达成全球战略合作与许可选择权协 议，泽璟制药将获得1 亿美元首付款，及基于临床进展的近期里程碑付款和与许可选择相关的付款最高 6,000 万美元，如艾伯维行使许可选择权，泽璟还有资格获得最高达10.75 亿美元的里程碑付款。 简评 注射用重组人促甲状腺激素：产品在术后辅助诊断适应症III 期临床中达到终点，已于2024 年6 月递交 上市许可申请并获得受理，目前已完成临床核查和二合一检查，审评处于正常流程。我国2022 年甲状 腺癌新发患者约46.61 万人，根据弗若斯特沙利文数据，预计2028 年中国重组人促甲状腺激素市场将达 5.71 亿元，公司 ...

Core Viewpoint - He Mei Pharmaceutical has submitted a prospectus to the Hong Kong Stock Exchange after the approval of its first new drug, Mufemilast, but faces significant challenges due to weak clinical data compared to competitors and limited market potential [1][2][11]. Company Overview - He Mei Pharmaceutical, established in 2002, focuses on discovering and developing small molecule drugs for autoimmune diseases and tumors [1][11]. - The company has completed several rounds of financing, with a post-investment valuation of 3.9 billion yuan after the E round [1][11]. Financial Performance - The company has not yet commercialized any products and has consistently reported losses, with projected losses of 156 million yuan, 123 million yuan, and 73 million yuan for 2023, 2024, and the first half of 2025, respectively [2][11]. - Cash reserves as of June 30, 2025, are approximately 73 million yuan, which may not sustain operations for a year based on historical cash usage [2][11]. Product Pipeline - He Mei Pharmaceutical has developed seven small molecule candidates, including Mufemilast, which has been approved for treating moderate to severe plaque psoriasis [2][11]. - Mufemilast's clinical efficacy data is significantly lower than that of comparable competitors, with PASI-75 and PASI-90 scores of 53.6% and 32.5% at week 16, respectively [4][14]. Competitive Landscape - The psoriasis treatment market is highly competitive, with 18 approved targeted drugs, including 13 biologics, and several others in clinical development [4][13]. - Mufemilast faces competition from established products with better clinical data and lower prices, which may limit its market entry and profitability [15][11]. Market Challenges - The pricing of psoriasis drugs has been significantly reduced due to national health insurance negotiations, putting pressure on Mufemilast's pricing and profit margins [15][11]. - The market for He Mei Pharmaceutical's unique indication for Mufemilast, treating Behçet's disease, is limited due to the low prevalence of the disease [10][18]. Additional Product Insights - Hemay022, another candidate for treating advanced breast cancer, is in phase III trials but targets a small patient population, which may limit its commercial potential [7][16]. - Clinical data for Hemay022 shows an objective response rate of 29.1% and a median progression-free survival (mPFS) of 9.0 months, which is lower than competitors [9][18].

Core Viewpoint - Haitong International has raised its revenue forecasts for BeiGene (06160) for FY25-27 to $5.3 billion, $6.4 billion, and $7.1 billion respectively, reflecting a three-year revenue CAGR of 23% due to stronger-than-expected market performance of Zebrutinib in the US and Europe [1] Group 1: Financial Performance - In Q3 2025, BeiGene achieved revenue of $1.41 billion, representing a year-on-year increase of 41% and a quarter-on-quarter increase of 7.7%, with product revenue at $1.40 billion [1] - The company reported a gross margin of 86.1%, an increase of 3.1 percentage points year-on-year [1] - R&D expenses were $520 million, reflecting a year-on-year increase of 5.5% [1] Group 2: Product Performance - Zebrutinib's global revenue is expected to approach $3.9 billion in 2025, with Q3 2025 global revenue at $1.04 billion, a year-on-year increase of 50.8% and a quarter-on-quarter increase of 9.6% [1] - In the US, Zebrutinib generated $740 million, a year-on-year increase of 46.7% and a quarter-on-quarter increase of 8.0% [1] - In Europe, Zebrutinib's revenue was $160 million, a year-on-year increase of 67.5% [1] Group 3: Pipeline Developments - In the hematological malignancies area, the focus is on BCL-2 inhibitors and BTK CDAC [1] - Management anticipates data for Sotigalimab (BCL-2 inhibitor) in R/R MCL to be released at the 2025 ASH meeting, with plans to submit a US marketing application for R/R MCL [1] - For BTK CDAC, phase II clinical data for R/R CLL is expected in 1H26, and a phase III trial has been initiated [1] Group 4: Solid Tumor Developments - The company is focusing on CDK4 inhibitors, with ongoing phase II clinical trials exploring two dosage levels, showing high response rates that support the initiation of phase III trials [2] - The B7-H4 ADC (BG-C9074) has completed dose escalation and is currently undergoing dose optimization studies in ovarian cancer, endometrial cancer, and breast cancer [2] - The PRMT5i (BGB-58067) has shown good safety and efficacy data, while the GPC3-targeting T-cell activator has demonstrated effectiveness in previously treated liver cancer patients [2]

Financial Data and Key Metrics Changes - Total revenues for Q3 2025 were $27.5 million, consisting of $25.7 million from Gemyto and $1.8 million from Zesturi, with Gemyto sales showing a 13% year-over-year growth when excluding CreateX sales from the previous year [22][24] - Net loss for Q3 2025 was $33.3 million, or $0.69 per share, compared to a net loss of $23.7 million, or $0.51 per share in Q3 2024 [24] - Cash, cash equivalents, and marketable securities totaled $127.4 million as of September 30, 2025 [24] Business Line Data and Key Metrics Changes - Gemyto generated net product revenue of $25.7 million, reflecting a 13% increase in underlying demand revenue over the same period in 2024 [6][22] - Zesturi sales were $1.8 million in Q3 2025, with a preliminary demand revenue estimate of $4.5 million for October, indicating strong early momentum [15][22] Market Data and Key Metrics Changes - Zesturi addresses an estimated $5 billion annual market, with expectations to become a standard of care and deliver over $1 billion in peak revenue [5][6] - The company has secured broad coverage across major payers, with Zesturi now accessible to over 95% of covered lives, approximately 296 million eligible patients [16] Company Strategy and Development Direction - The company is focused on the ongoing commercialization of Zesturi and Gemyto, with Zesturi being the primary growth driver [3][4] - A permanent product-specific J code for Zesturi is expected to take effect on January 1, 2026, which is anticipated to accelerate adoption [19][20] - The company plans to submit a New Drug Application (NDA) for UGN-103 in the second half of 2026, with potential approval anticipated in 2027 [8][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term potential for Zesturi, citing positive physician feedback and increasing patient enrollment forms [4][5] - The company acknowledged logistical and operational challenges affecting the conversion of patient enrollment forms to actual patient dosing but expects improvements as practices gain experience [18][32] - Management emphasized the importance of the upcoming permanent J code in simplifying reimbursement and reducing barriers to adoption [19][20] Other Important Information - R&D expenses for Q3 2025 were $14 million, primarily driven by costs associated with the phase 3 Utopia trial for UGN-103 [22] - Selling, general, and administrative expenses increased to $37.6 million, driven by Zesturi commercial preparation activities and expansion of the sales force [23] Q&A Session Summary Question: Can you explain the timing for revenue recording and remittance? - Management indicated that the average lag time between patient enrollment form submission and patient dosing is currently 45-60 days, with expectations for gradual improvement as practices gain experience [31][33] Question: What visibility is there into physicians waiting for the permanent J code? - Management noted that many physicians are interested in prescribing Zesturi but are waiting for the permanent J code to take effect [36][40] Question: How are patient enrollment forms tracking month over month? - Management reported steady growth in patient enrollment forms, with some weeks showing equal or greater numbers compared to Gemyto [45][48] Question: What is the expected impact of the J code on lag time for patient dosing? - Management anticipates that the lag time will gradually decrease, potentially reaching below 30 days as practices become more familiar with the process [58][61] Question: Will additional capital be needed in 2026? - Management expressed confidence in their current cash position and operational plans, believing they can reach profitability without needing additional capital [70]

（一家於中華人民共和國註冊成立的股份有限公司） 重要提示 重要提示： 閣下如對本招股章程的任何內容有任何疑問，應徵詢獨立專業意見。 Xuanzhu Biopharmaceutical Co., Ltd. 軒竹生物科技股份有限公司 全球發售 獨家保薦人及保薦人兼整體協調人 聯席整體協調人、聯席全球協調人、聯席賬簿管理人及聯席牽頭經辦人 香港交易及結算所有限公司、香港聯合交易所有限公司及香港中央結算有限公司對本招股章程的內容概不負責，對其準確性或完整性亦不發表任何聲明，並明 確表示概不就因本招股章程全部或任何部分內容而產生或因倚賴該等內容而引致的任何損失承擔任何責任。 本招股章程，連同本招股章程「附錄七－送呈公司註冊處處長及展示文件」所述的文件，已按照香港法例第32章公司（清盤及雜項條文）條例第342C條的規定由 香港公司註冊處處長登記。香港證券及期貨事務監察委員會及香港公司註冊處處長對本招股章程或上述任何其他文件的內容概不負責。 發售價將為11.60港元。香港發售股份申請人於申請時須支付發售價每股香港發售股份11.60港元，連同1.0%經紀佣金、0.0027%證監會交易徵費、0.00015%會 財局交易徵費及0 ...

Company Overview - Esperion Therapeutics is focused on commercializing life-saving medications, specifically NEXLIZET and NEXLETOL [3] - The company is also developing additional life-saving medications, with a recent R&D Day highlighting interesting compounds [3] Financial Performance - Esperion reported significant momentum in its Q2 results, showing double-digit growth across all metrics [3] Industry Engagement - The company had a successful presence at the European Society of Cardiology, which positively influenced its guidelines [3]

Performance Highlights - The company reported cash and cash equivalents of 1.051 billion [4] - Significant progress in core pipeline with the acceptance of NDA for both 0.01% and 0.02% concentrations of Atropine (NVK002) for myopia in children by the National Medical Products Administration [4][21] - The company is the only one in China with two specifications of Atropine under review [19] Product Pipeline - The company has initiated clinical trials for the new drug application (NDA) of Cyclosporine eye gel for dry eye syndrome, which has been accepted by the regulatory authority [5] - The company has received FDA approval for the Phase III clinical trial application for the same product in the U.S. [5] - The company is advancing its product pipeline with several candidates including BRIMOCHOL™ PF for presbyopia and TAB014 for wet age-related macular degeneration (wAMD) [40][36] Market Expansion - The company is expanding its overseas presence and has established partnerships for drug production and supply in various regions including Australia, New Zealand, and Southeast Asia [60] - The company has covered over 1,200 hospitals across 30 provinces in China, including major eye hospitals [57] - The company is leveraging e-commerce platforms such as Tmall and JD for product distribution [58] Research and Development - The company is focusing on innovative drug formulations and delivery methods to improve patient compliance and reduce treatment burden [47][49] - The company has a comprehensive clinical data set supporting its product candidates, enhancing its competitive advantage in the market [22][29] - The company is preparing for IND submissions for several candidates, including PAN-90806 for wAMD and diabetic macular edema [50][46]

Group 1 - The company achieved a revenue of 950 million yuan in H1 2025, a year-on-year decrease of 31.3%, primarily due to high milestone payments recognized in the same period of 2024 [1] - The net loss attributable to the parent company was 145 million yuan, with an adjusted net loss of 69 million yuan [1] - The pharmaceutical sales revenue reached 309.8 million yuan, with sac-TMT accounting for 97.6% of total pharmaceutical sales, indicating successful commercialization progress [1][2] Group 2 - The sales revenue from sac-TMT is mainly derived from second-line triple-negative breast cancer and third-line EGFR mutation NSCLC, with the second-line EGFR mutation NSCLC indication expected to be approved in China soon, potentially driving stronger annual sales growth [2] - Sac-TMT's two approved indications will participate in the 2025 medical insurance negotiations, with expectations for accelerated sales growth after entering the insurance directory in 2026 [2] - Multiple clinical data will be disclosed at the ESMO conference in H2 2025, including phase III data for sac-TMT in second-line EGFR mutation NSCLC and phase I data for SKB315 (CLDN18.2 ADC) [2] Group 3 - The company's other core product, HER2 ADC (Bodutuzumab), received NDA acceptance in January 2025 and is expected to be approved for market launch in H2 2025 [3] - The company plans to submit the NDA application for the next-generation RET inhibitor A400 in H2 2025 [3] - The next major product, SKB571/MK-2750 (dual antibody ADC), is set to begin phase II clinical trials in China soon [3]

Core Viewpoint - HeYue-B (02256) has seen a significant stock price increase of nearly 9%, with a cumulative rise of almost 40% post-earnings report, reaching a historical high of 14.65 HKD [1] Financial Performance - For the first half of the year, the company reported revenue of 612 million HKD, representing a year-on-year growth of 23% [1] - The profit for the same period was 328 million HKD, showing a substantial year-on-year increase of 59% [1] Key Drivers - The earnings exceeded expectations primarily due to Merck's exercise of the commercialization option, which was above forecasts [1] - In April, HeYue announced that Merck exercised its global commercialization option for pimicotinib, followed by receiving an 85 million USD fee in May [1] Valuation and Future Prospects - Citigroup indicated that the current valuation of HeYue is low, considering the high certainty of its two late-stage candidates, pimicotinib and irpagratinib, along with a differentiated innovation pipeline that may lead to external licensing opportunities [1] - The firm anticipates a high success rate for the phase III clinical trial of irpagratinib in second-line hepatocellular carcinoma, suggesting that this should be factored into the company's valuation [1] - Key catalysts are expected in 2025 and 2026, including the approval and commercialization performance of pimicotinib, the release of phase III data for irpagratinib, updates on other candidates like ABSK043 and ABSK061, and potential commercial collaborations [1]

Core Viewpoint - HeYue-B (02256) has seen a significant stock price increase of nearly 9% post-earnings, with a cumulative rise of close to 40%, reaching a historical high of 14.65 HKD, driven by strong financial performance and positive market sentiment [1] Financial Performance - For the first half of the year, HeYue reported revenue of 612 million HKD, representing a year-on-year growth of 23% [1] - The company's profit reached 328 million HKD, marking a substantial year-on-year increase of 59% [1] Market Reactions - CICC noted that the company's performance exceeded expectations, primarily due to higher-than-expected income from Merck [1] - Citigroup highlighted that HeYue's current valuation is low, considering the high certainty of its two late-stage candidates, pimicotinib and irpagratinib, and the potential for differentiated innovation pipeline to secure external licensing [1] Future Catalysts - Citigroup anticipates key catalysts for HeYue in 2025 and 2026, focusing on the approval and commercialization of pimicotinib, the release of phase III data for irpagratinib, and updates on other candidates like ABSK043 and ABSK061, along with potential commercial collaborations [1]