香港交易及結算所有限公司及香港聯合交易所有限公司（「聯交所」）對本公告的內容概不負責，對其 準確性或完整性亦不發表任何聲明，並明確表示，概不對因本公告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。 CLOUDBREAK PHARMA INC. CBT-004是一種潛在的同類首創眼科藥物，採用多激酶抑制劑，靶向血管內皮生長因子受體及血小板 衍生生長因子受體，適用於治療血管化瞼裂斑。本集團於2023年12月開始CBT-004的第2期臨床試驗， 並於2025年5月完成。結果表明，CBT-004 在受試者中是安全且耐受性良好的，並在療效方面達到 了主要終點以及若干次要終點。本集團已於2025年7月完成臨床試驗報告並計劃與美國食品及藥物管 理局舉行第2期臨床試驗後會議。 撥 康 視 雲 製 藥 有 限 公 司 * （於開曼群島註冊成立的有限公司） （股份代號：2592） 自願公告 業務最新進展 本公告乃由撥康視雲製藥有限公司（「本公司」，連同其附屬公司統稱「本集團」）作出的自願公 告，以知會本公司股東及潛在投資者有關本集團的最新業務發展。 本公司董事會（「董事會」）欣然宣佈，本公司於美利堅合眾 ...

Core Viewpoint - Cytokinetics reported a narrower net loss in Q3 2025 compared to previous estimates, but revenues fell short of expectations, leading to a mixed outlook for the company as it prepares for upcoming regulatory decisions regarding its lead drug candidate, aficamten [2][3][4]. Financial Performance - The net loss for Q3 2025 was $1.54 per share, which was better than the Zacks Consensus Estimate of a loss of $1.59, but worse than the loss of $1.36 per share reported in the same quarter last year [2]. - Revenues for the quarter totaled $1.9 million, missing the Zacks Consensus Estimate of $6 million, but showing an increase from $0.4 million in the year-ago quarter [3]. - R&D expenses rose by 17.3% year-over-year to $99.2 million, driven by clinical trial advancements and higher personnel costs [4]. - General and administrative expenses increased by 22.6% to $69.4 million, attributed to investments in the commercial readiness of aficamten and personnel-related expenses [4]. - As of September 30, 2025, the company had approximately $1.25 billion in cash and investments, up from $1.04 billion at June 30, 2025 [4]. Drug Development Updates - Aficamten, a cardiac myosin inhibitor for obstructive hypertrophic cardiomyopathy (HCM), has had its FDA target action date extended to December 26, 2025 [5]. - Cytokinetics participated in a late-cycle meeting with the FDA regarding aficamten's NDA, discussing its proposed Risk Evaluation and Mitigation Strategy (REMS) [6]. - The company is also addressing questions from the EMA regarding aficamten's marketing authorization application, with a potential decision expected in the first half of 2026 [7]. - Aficamten is being evaluated in multiple clinical trials, including MAPLE-HCM, which reported positive top-line results, and ACACIA-HCM, with results expected in Q2 2026 [8][9]. Pipeline Candidates - Other pipeline candidates include omecamtiv mecarbil, currently in a phase III trial for heart failure, and ulacamten, which is in a phase II trial for heart failure with preserved ejection fraction [10][11]. Market Sentiment and Outlook - Since the earnings release, there has been a downward trend in fresh estimates, with the consensus estimate shifting by 8.51% [12]. - Cytokinetics has a subpar Growth Score of D and a Momentum Score of B, but an overall VGM Score of F, indicating challenges in value [13]. - The stock has a Zacks Rank of 3 (Hold), suggesting an expectation of in-line returns in the coming months [14].

Axsome Therapeutics FY Conference Summary Company Overview - **Company**: Axsome Therapeutics (NasdaqGM:AXSM) - **Event**: FY Conference on December 03, 2025 Key Points Industry and Product Updates - **Auvelity and Alzheimer's Disease (AD) Agitation**: - Axsome is awaiting an acceptance decision for the supplemental new drug application (SNDA) for Auvelity in AD agitation, which was submitted in early November [3][5][10] - The expectation is for a standard review due to FDA resource constraints, despite having three positive trials and breakthrough therapy designation [10][11] - The company believes the trial package is robust, consisting of one randomized parallel group study and two randomized withdrawal studies [10][12][22] Commercialization Strategy - **Sales Force Expansion**: - Currently, Axsome has approximately 300 sales representatives detailing for Major Depressive Disorder (MDD) and plans to expand the team upon approval for AD agitation [24][26] - The peak sales opportunity for AD agitation is estimated between $1.5 billion and $3 billion, while MDD is estimated at $1 billion to $3 billion, totaling $2.5 billion to $6 billion [30][32] - A discrete field force team will be established for long-term care facilities, recognizing the comorbidity between MDD and AD agitation [32][34] Market Access and Coverage - **Access to Auvelity**: - Currently, there is 100% access in the government channel and 75% in the commercial channel, leading to an overall 85% total covered lives [47][47] - The majority of prescriptions are expected to come from the government channel, with high-quality access anticipated for the AD agitation indication [47][123] Direct-to-Consumer (DTC) Campaign - **DTC Campaign for Auvelity**: - A national TV DTC campaign launched in September has shown positive results, with new prescriptions (NBRXs) increasing from 2,000 to over 2,800 per week [75][78] - The campaign is expected to continue through 2026, with adjustments made based on market conditions [79][100] Product Performance and Market Position - **Auvelity in MDD**: - Over 50% of prescriptions are now for monotherapy, with 15% first-line and 35% second-line usage [103][108] - The gross-to-net (GTN) improved from mid-50s% in Q1 and Q2 to high 40s% in Q3, with expectations for a slight uptick in Q4 [122][123] Pipeline Developments - **Solriamfetol**: - Axsome is excited about the potential of Solriamfetol in various CNS settings, with studies underway for ADHD, MDD with excessive daytime sleepiness, and binge eating disorder [159][161][186] - The company anticipates starting a pediatric ADHD study this quarter and expects top-line results for binge eating disorder next year [174][190] New Product Development - **GABA-A Alpha 2/3 Modulator**: - Axsome is exploring the value proposition of a new GABA-A modulator for epilepsy and psychiatric indications, with preclinical work already underway [200][206] - The company is taking an opportunistic approach to expand its early-stage pipeline [211][220] Conclusion - Axsome Therapeutics is strategically positioned with a robust pipeline and commercialization plans, focusing on expanding its market presence in both existing and new indications while maintaining a strong emphasis on data-driven decision-making and market access strategies.

Financial Data and Key Metrics Changes - The company announced a $7 billion commitment to expand R&D capabilities and domestic manufacturing [6] - The cash balance remains substantial, with ongoing dividends and buybacks, but the company is open to M&A opportunities if the right conditions arise [11][12] Business Line Data and Key Metrics Changes - Eylea HD received recent approvals for RVO and Q4 dosing, with expectations for commercial impact starting in 2026 [17] - Dupixent continues to grow robustly, treating over 1.3 million patients globally, with significant market expansion opportunities in atopic dermatitis and asthma [30][31] Market Data and Key Metrics Changes - The company is actively monitoring the impact of biosimilars on Eylea, noting that any conversions to biosimilars still position patients as candidates for Eylea HD [24] - The COPD launch has shown strong performance, with Dupixent being the best-performing respiratory launch for the company [34] Company Strategy and Development Direction - The company is committed to domestic manufacturing and enhancing internal capabilities while exploring external opportunities for growth [6][12] - The focus remains on investing in the pipeline and fostering innovation to drive long-term shareholder value [10] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, particularly regarding the Eylea HD enhancements and the ongoing growth of Dupixent [21][30] - The company is closely watching policy changes related to drug pricing and their potential impact on Eylea and other products [26] Other Important Information - The company is preparing for a submission for a prefilled syringe for Eylea HD, expected in the second quarter [18] - Linvoseltamab has shown promising data in the myeloma market, with plans for further studies in earlier lines of therapy [63] Q&A Session Summary Question: Update on policy and macro environment - The company has committed to domestic manufacturing and is in active negotiations regarding drug pricing policies [6][9] Question: Thoughts on M&A and business development - The company is open to M&A opportunities but prioritizes internal investments and collaborations [12][13] Question: Eylea HD commercial impact and competition - Eylea HD enhancements are expected to drive growth starting in 2026, despite current payer issues [21][24] Question: Dupixent growth drivers - Dupixent is benefiting from market expansion in atopic dermatitis and asthma, with significant room for growth [30][31] Question: Linvoseltamab in myeloma - Linvoseltamab has shown best-in-class data among BCMA bispecifics, with ongoing studies to simplify treatment algorithms [62][63]

Financial Data and Key Metrics Changes - The company announced a $7 billion commitment to expand R&D capabilities and domestic manufacturing, indicating a strong focus on internal growth and innovation [6][9] - The company has a substantial cash balance and has initiated dividends and buybacks, reflecting a solid financial position [11] Business Line Data and Key Metrics Changes - Eylea HD received recent approvals for RVO and Q4 dosing, with expectations for commercial impact starting in 2026 [17][18] - Dupixent continues to grow robustly, treating over 1.3 million patients globally, with significant market expansion opportunities in atopic dermatitis and asthma [30][31] Market Data and Key Metrics Changes - The company is actively monitoring the impact of biosimilars on Eylea, noting that while they present challenges, Eylea HD remains a strong competitor [24] - The COPD launch has been successful, with Dupixent showing a significant reduction in exacerbation rates compared to competitors [33][34] Company Strategy and Development Direction - The company is committed to domestic manufacturing and enhancing its R&D capabilities, aiming to meet the demands of its growing pipeline [6][15] - There is an openness to exploring external opportunities for M&A, although the focus remains on internal capabilities and collaborations [12][13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the alignment with government goals regarding drug pricing and innovation, emphasizing the importance of fostering a supportive environment for the industry [9] - The company is optimistic about the future growth of its products, particularly with the enhancements to Eylea and the ongoing success of Dupixent [22][30] Other Important Information - The company is awaiting the first round of Part B IRA drug selections, which could impact Eylea's market position [26][28] - Linvoseltamab is showing promising results in a crowded myeloma market, with best-in-class data among BCMA bispecifics [62] Q&A Session Summary Question: Update on manufacturing and policy context - The company has committed to expanding domestic manufacturing and is in active negotiations regarding drug pricing with the administration [6][7] Question: Future M&A considerations - The company is open to external opportunities but prioritizes internal investments and collaborations [12][13] Question: Eylea HD commercial impact - Eylea HD enhancements are expected to have a significant impact starting in 2026, with ongoing efforts to convert patients from Eylea 2 mg to Eylea HD [21][22] Question: Competition from biosimilars - Biosimilars present challenges, but Eylea HD is positioned as a strong competitor with unique advantages [24] Question: Growth drivers for Dupixent - Dupixent continues to grow due to its market-leading position and under-penetrated opportunities in atopic dermatitis and asthma [30][31] Question: COPD launch and patient adoption - The COPD launch has been successful, with significant patient adoption and positive feedback on efficacy [33][34] Question: Future pipeline developments - The company is focused on advancing its pipeline, including LAG-3 and Linvoseltamab, with promising data expected in the near future [40][62]

Core Insights - The demand for flu medications, particularly Oseltamivir, has surged due to the onset of the flu season, leading to significant sales increases for products like Oseltamivir and Marbofloxacin [1] - Dongyangguang Pharmaceutical has raised the price of its new Oseltamivir granules after opting out of the national centralized procurement, which has resulted in a substantial decline in the company's net profit since 2024 [1][3] - The company has seen a drastic drop in revenue and market share for its flagship product, "Kewai" (Oseltamivir), which previously dominated the market [2][3] Company Performance - Dongyangguang Pharmaceutical's revenue fell from 6.386 billion yuan in 2023 to 4.019 billion yuan in 2024, with net profit plummeting from 1.014 billion yuan to 24.8 million yuan, a decline of 97% [3] - The sales revenue of Oseltamivir dropped to 2.58 billion yuan in 2024, down 50% year-on-year, and its market share decreased from 64.8% in 2023 to 54.8% in 2024 [2][3] Market Dynamics - The 11th batch of national centralized procurement for Oseltamivir saw winning bids at prices of 17.88 yuan and 19.03 yuan for 900mg specifications, which is 16 times lower than Dongyangguang's new product price [2] - The competitive landscape for Oseltamivir has intensified, with over 40 companies now selling the drug, including notable firms like Shuanglu Pharmaceutical and Jilin Aodong [2] Strategic Shifts - Dongyangguang is attempting to reduce its reliance on Oseltamivir by focusing on chronic disease treatments, which contributed 1.068 billion yuan in revenue in 2024, accounting for 26.6% of total revenue [4] - The company has over 100 products in its research pipeline, but only one is at the application stage for market approval, indicating a low maturity level in its product development [4] Future Outlook - If the market share for Oseltamivir continues to decline, it may be challenging for new business segments to compensate for the revenue shortfall [5]

Financial Data and Key Metrics Changes - The company expects over $1 billion in sales from its two commercial products, NUPLAZID and DAYBUE, for the current year [5] - NUPLAZID's sales guidance for the year has been narrowed to a range of $685 million to $695 million, indicating an upward shift from previous estimates [23][24] - The company maintains a strong balance sheet with over $800 million in cash and no debt, allowing for continued investment in business development [6][105] Business Line Data and Key Metrics Changes - NUPLAZID has seen a 20% increase in both referrals and new patient starts, marking the strongest quarter in new patient starts in a long time [10] - DAYBUE has experienced significant increases in new referrals, the largest since Q3 2024, indicating early success from increased investment in U.S. infrastructure [12] - The company plans to expand its customer-facing field force to further drive growth and profitability for both NUPLAZID and DAYBUE [11] Market Data and Key Metrics Changes - The company is preparing for European approval of DAYBUE next year, aiming to expand its market presence outside the U.S. [12][55] - The market for Alzheimer's disease psychosis (ADP) is significantly larger than that for Parkinson's disease psychosis (PDP), presenting a substantial growth opportunity [70] Company Strategy and Development Direction - The company is focused on expanding its commercial footprint and increasing investments in marketing and sales to enhance product awareness and penetration [11][12] - A robust pipeline is in place, with ACP-204 being the most advanced program targeting Alzheimer's disease psychosis and Lewy body dementia psychosis [6][61] - The company is committed to maintaining profitability while navigating potential price decreases due to future negotiations under the IRA [34] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in continued meaningful growth for both franchises, with plans to provide guidance on peak sales for NUPLAZID next year [28] - The company is mindful of potential legislative impacts but does not anticipate significant disruptions to its growth strategy in the near term [34] Other Important Information - The company has a stable patient base for DAYBUE, with over 70% of patients on therapy for 12 months or longer, indicating strong treatment adherence [40] - The company is actively building a team in Europe to prepare for the launch of DAYBUE, with a focus on establishing scientific conversations and market access [55] Q&A Session Summary Question: Can you provide an overview of the commercial performance for NUPLAZID and DAYBUE? - Management highlighted a strong quarter for NUPLAZID with a 20% increase in new patient starts and significant growth for DAYBUE due to increased referrals [10][12] Question: What is the sales guidance for NUPLAZID this year? - The sales guidance has been narrowed to a range of $685 million to $695 million, reflecting an upward adjustment [23][24] Question: How does the IRA impact the company? - Management indicated that while there may be price decreases in the future, the company expects to remain profitable and continue driving growth [34] Question: What is the strategy for expanding DAYBUE in Europe? - The company plans to market DAYBUE independently in Europe, starting with Germany, and has begun building a team to support this effort [55] Question: What are the expectations for the upcoming phase II readout for ACP-204? - Management expressed excitement about the phase II readout for ACP-204, viewing it as a higher probability of success due to prior learnings from pimavanserin [61][62]

Summary of Nuvation Bio Conference Call Company Overview - **Company**: Nuvation Bio - **Key Executives**: CEO David Hung, CFO Philippe Sauvage - **Industry**: Biotechnology, specifically focused on oncology treatments Key Accomplishments in 2025 - **Acquisition of AnHeart**: Marked a transformative event for the company, leading to FDA approval and the launch of Ibtrozy, establishing Nuvation as a commercial-stage company [2] - **Sales Performance**: First full quarter of sales for Ibtrozy was robust, with 204 patient starts, significantly higher than competitors [8][9] Product Focus: Ibtrozy (ROS1 Inhibitor) - **Clinical Data**: - Response rate of 90% and progression-free survival (PFS) of 40 months, with a duration of response (DOR) of 50 months [5] - Compared to competitors, Ibtrozy shows superior efficacy with lower discontinuation rates (0.3% for top adverse events) [6][7] - **Market Demand**: Strong initial demand with no patient bolus from clinical trials, indicating a significant unmet need in the market [9][10] - **NCCN Guidelines Impact**: Recent changes in guidelines now mandate the use of ROS1 agents over immuno-oncology chemotherapy, providing a favorable market environment for Ibtrozy [11][12][13] Future Growth Potential - **Revenue Projections**: Anticipated revenues could exceed $4 billion annually from DNA testing and over $5 billion from RNA testing due to the drug's efficacy and market demand [7][17] - **Testing Transition**: Shift from DNA to RNA testing expected to increase patient identification and treatment opportunities [17][18] Other Product Development: Safusidenib - **Pivotal Trial for High-Grade Glioma**: Expected to differentiate from existing treatments, with a response rate of 44% compared to 11% for the competitor [20][21] - **Adverse Event Profile**: Favorable tolerability with immune-like adverse events, suggesting a unique mechanism of action [22][23] Strategic Outlook for 2026 - **Sales Expectations**: Continued strong sales for Ibtrozy anticipated, with ongoing enrollment in pivotal studies for Safusidenib [33] - **Financial Position**: Company holds $550 million in cash, allowing for strategic business development and internal program advancements [33][34] Additional Insights - **DDC Platform**: NUV1511 was discontinued due to inconsistent responses in trials, but the company remains committed to the DDC platform with plans for future developments [30][31] - **Regulatory Environment**: Ongoing discussions with the FDA regarding trial endpoints and imaging techniques may influence future study designs and timelines [27][28] This summary encapsulates the key points discussed during the conference call, highlighting Nuvation Bio's strategic positioning, product performance, and future growth potential in the biotechnology sector.

Core Viewpoint - Sanofi Pharmaceutical (01530) announced a share placement agreement to raise approximately HKD 31.15 billion, with a share price discount compared to recent trading prices [1] Group 1: Share Placement Details - The company will issue 105 million shares at a price of HKD 29.62 per share [1] - The placement price represents a 6.50% discount to the closing price of HKD 31.68 on the trading day prior to the agreement [1] - The average closing price over the previous five trading days was HKD 31.28, indicating a discount of approximately 5.29% [1] Group 2: Fund Utilization - Approximately 80% of the raised funds will be allocated to research and development expenditures, focusing on advancing clinical studies for innovative drugs [1] - The remaining 20% will be used for operational funding and other general purposes [1]

Core Insights - Bristol Myers Squibb (BMY) received European Commission approval for Breyanzi, expanding its label to include treatment for adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton's tyrosine kinase (BTK) inhibitor [1][9] Group 1: Breyanzi Approval and Indications - The latest approval marks the fourth for Breyanzi in Europe, which is already approved for several other indications including relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBCL) [2] - Breyanzi is indicated for patients who relapsed within 12 months of first-line chemoimmunotherapy or are refractory to it, as well as for those with relapsed or refractory DLBCL, PMBCL, and FL3B after two or more lines of therapy [3] Group 2: Clinical Trial Results - The approval is based on the TRANSCEND NHL 001 trial results, where 82.7% of patients responded to Breyanzi, with 71.6% achieving a complete response, and 41.2% of patients maintained their response at 24 months [4][9] Group 3: Pipeline Expansion and Market Impact - Bristol Myers is focusing on expanding its pipeline due to the negative impact of generics on its legacy portfolio, including Revlimid and Pomalyst [5] - The company’s shares gained 3.3% following positive data from Bayer's cardiovascular candidate asundexian, which may boost investor confidence in BMY's own cardiovascular candidate, milvexian [6][8] Group 4: Discontinuation of Librexia Study - Bristol Myers and Johnson & Johnson decided to discontinue the late-stage Librexia study for milvexian after an interim analysis indicated it was unlikely to meet primary efficacy endpoints, although two other studies for milvexian will continue [10][11]