Dramatically improved disease control with 21.2 months vs. 2.9 months median event-free survival (EFS) Favorable safety profile with 7% vascular occlusion rate Broad patient benefit with proven effectiveness even in patients without T315I mutation (11.9 vs. 3.1 months event-free survival) ROCKVILLE, Md. and SUZHOU, China, Dec. 08, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855), a global, commercial stage, integrated biopharmaceutical company engaged in the discovery ...

76.7% complete cytogenetic response rate achieved in patients who failed second-generation TKI first-line therapy Molecular responses continue to deepen with extended treatment duration, reaching 60% major molecular response at 21 cyclesStrong efficacy data support potential advancement to earlier treatment lines for a broader patient population ROCKVILLE, Md. and SUZHOU, China, Dec. 08, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855), a global, commercial-stage, int ...

Core Insights - Ascentage Pharma has received FDA and EMA clearance for a global Phase III study of olverembatinib in combination with chemotherapy for newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) patients [1][2] - The POLARIS-1 trial aims to accelerate the registration process of olverembatinib in the US and European markets [1] - Initial data from the POLARIS-1 study indicates a 65% minimal residual disease (MRD) negativity rate and molecular MRD-negative complete response (CR) rate after three treatment cycles, showing improved efficacy compared to existing therapies [3] Company Overview - Ascentage Pharma is a global biopharmaceutical company focused on developing novel therapies for unmet medical needs in cancer [6] - The company has a diverse pipeline, including olverembatinib, a third-generation BCR-ABL inhibitor, and lisaftoclax, a Bcl-2 inhibitor [7][8] - Olverembatinib has been approved in China for multiple indications in drug-resistant chronic myeloid leukemia (CML) and is included in the National Reimbursement Drug List (NRDL) [7] Clinical Development - The POLARIS-1 study is a multicenter, randomized controlled trial designed to evaluate the safety and efficacy of olverembatinib in Ph+ ALL patients [2] - The study has also been initiated in China following clearance from the China Center for Drug Evaluation (CDE) [2] - Olverembatinib has received Breakthrough Therapy Designation from the China CDE, highlighting its potential in treating Ph+ ALL [3][4] Strategic Partnerships - Ascentage Pharma has signed an exclusive option agreement with Takeda for olverembatinib, which could lead to Takeda licensing global rights outside of certain regions [4] - The company collaborates with various leading biotechnology and pharmaceutical firms, enhancing its research and development capabilities [9]

Summary of the Conference Call on China Healthcare Sector Industry Overview - The conference call focused on the **China healthcare sector**, highlighting recent weaknesses and potential opportunities for 2026 [2][5][6]. Core Insights and Arguments - **Current Market Performance**: The Hang Seng Healthcare Index (HSHCI) has declined by **3.1%**, while the Hang Seng Index fell by **1.6%**. The HSHCI has dropped approximately **17%** from its year-to-date high in early October, with some small and mid-cap stocks down around **30%** [2][5]. - **Valuation Outlook**: Despite the current weakness, the fundamentals of the sector remain intact, and valuations are becoming more attractive, suggesting a potential rebound in 2026 [2][5][6]. - **Investment Recommendations**: - **Biotech**: Innovent and Kelun Biotech (rated Overweight) - **Pharma**: Hansoh Pharma and Hengrui-A (rated Overweight) - **CXO**: WuXi Apptec and WuXi XDC (rated Overweight) - Caution is advised regarding Akeso due to unclear updates on HARMONi-2 OS [2][5][6]. Upcoming Events and Legislative Considerations - **NRDL Price Negotiations**: Anticipated results from the National Reimbursement Drug List (NRDL) price negotiations are expected to be neutral to negative, reflecting the current weak sentiment [5][6]. - **Biosecure Act**: The potential passing of the Biosecure Act could be a negative headline event, although it is not expected to significantly impact China CXOs' business [5][6]. - **Medical Conferences**: Upcoming medical conferences in December (e.g., ASH'25 and SABCS'25) are not expected to affect overall sentiment towards the China healthcare sector [5][6]. Emerging Themes for 2026 - Potential interest in new drug modalities such as **siRNA** (small interfering RNA) and **RDC** (radionuclide drug conjugate) is anticipated, along with expectations for global Phase 3 data from out-licensed assets [5][6]. - A healthy out-licensing deal flow is expected in 2026, although it may not surpass the total deal size of 2025 due to several significant deals this year [6]. - The **JPM Global Healthcare Conference** in January 2026 is expected to provide further insights into the prospects for the China healthcare sector, with presentations from over a dozen public and private Chinese companies [6]. Key Companies Discussed - **Akeso** (9926.HK) - **Hansoh Pharma** (3692.HK) - **Hengrui** (600276.SS) - **Innovent Biologics** (1801.HK) - **Kelun Biotech** (6990.HK) - **WuXi AppTec** (603259.SS and 2359.HK) - **WuXi XDC** (2268.HK) [8]. Conclusion - The China healthcare sector is currently facing challenges but presents potential investment opportunities as valuations become more attractive. Key themes and developments in 2026 will be closely monitored, particularly in light of upcoming conferences and legislative changes [2][5][6].

Core Insights - Ascentage Pharma announced promising results from a Phase Ib study of olverembatinib for treating SDH-deficient GIST, published in a high-impact journal [2][4][3] - The study is the largest prospective clinical trial to date for this rare tumor subtype, demonstrating significant clinical benefits and a novel mechanism of action [4][7][8] Company Overview - Ascentage Pharma is a global biopharmaceutical company focused on developing therapies for unmet medical needs in cancer [12] - The company has a diverse pipeline, including olverembatinib, which is a third-generation BCR::ABL1 inhibitor approved in China for specific indications [13][12] Clinical Study Details - The Phase Ib study involved 66 patients, including 26 with SDH-deficient GIST, showing an objective response rate (ORR) of 23.1% and a clinical benefit rate (CBR) of 84.6% [4][5] - The median progression-free survival (mPFS) for patients with SDH-deficient GIST was reported at 25.7 months [4][5] Mechanism of Action - Olverembatinib modulates lipid metabolism, inhibiting CD36 expression, which is linked to enhanced uptake of exogenous lipids in SDH-deficient tumors [6][7] - The study established a direct link between SDH deficiency and dysregulated lipid metabolism, providing a new therapeutic target for SDH-deficient GIST [7][6] Future Directions - Ascentage Pharma plans to continue clinical development of olverembatinib, with ongoing studies to validate its efficacy and safety in SDH-deficient GIST [9][10] - The drug has received Breakthrough Therapy Designation in China for this indication, indicating its potential as a new treatment option [10][11]

Summary of Innovent Biologics (1801.HK) Conference Call Company Overview - **Company**: Innovent Biologics (1801.HK) - **Industry**: China Pharma, Biotech & Medtech Key Points Takeda Partnership - Innovent Biologics announced an **US$11 billion** deal with Takeda, highlighting Takeda's commitment as a partner for IBI363 and IBI343 [5] - The collaboration reflects a **US$50 billion+** global total addressable market (TAM) as outlined in Takeda's Q2 2025 results [5] - The clinical development plan (CDP) will focus on **NSCLC (Non-Small Cell Lung Cancer)** and **CRC (Colorectal Cancer)**, with five global Phase 3 trials planned [5] - Innovent will lead exploratory trials in China for other indications to guide global trials [5] - Innovent has a strong cash position, with **US$1.3 billion** in cash as of June 30, 2025, to support a **40/60** split on global R&D costs, estimated at **US$1.5-2 billion** for the first five global Phase 3 trials [5] Near-term Growth Drivers - **CVM (Cardiovascular Metabolism)** assets are identified as the primary growth drivers towards a target of **RMB 20 billion** by 2027 [5] - Key contributors include: - **Mazdutide**: Participating in the Double 11 online promotion with encouraging initial orders [5] - **Tafolecimab (PCSK9)**: Experienced a quick ramp-up post-NRDL coverage, with market growth observed at **20+%** [6] - **IBI311 (IGF-1R)**: Good initial adoption expected to increase with potential NRDL coverage in 2026 [6] IBI363 Catalyst - Multiple data readouts for IBI363 are planned in 2026, including: - Phase 1/2 POC data for **1L NSCLC** and **1L CRC** in **2H26**, considered a key catalyst [6] - Novel ADC pipeline readouts, including IBI3001, IBI3005, and IBI3020 [6] - Phase 1 data for an oral small-molecule GLP-1 and autoimmune readouts [6] Financial Outlook and Risks - The 12-month price target is set at **HK$103.22**, with a current price of **HK$90.20**, indicating an upside of **14.4%** [7] - Key financial metrics include: - Market cap: **HK$146.3 billion / US$18.8 billion** - Revenue projections for 2025E: **RMB 12,694.9 million** [7] - EPS projections for 2025E: **RMB 0.54** [7] - Risks include: - Intensifying competition in the PD-1/L1 market in China - Uncertain approval timelines for key candidates - Potential restrictions on off-label use due to safety issues - Failure of R&D projects [6] Valuation Metrics - **P/E Ratio**: Projected to be **30.3x** in 2026E [7] - **P/B Ratio**: Expected to be **7.5x** in 2026E [7] - **Free Cash Flow Yield**: Projected at **2.7%** in 2026E [7] Additional Insights - The management emphasized the importance of maintaining a competitive edge through innovative product designs and strategic partnerships [5][6] - The focus on market share gain in 2026 is prioritized over reducing sales expense ratios [6] This summary encapsulates the critical insights from the conference call, providing a comprehensive overview of Innovent Biologics' strategic direction, financial outlook, and market positioning.

Core Insights - Fangzhou Inc. has achieved a significant milestone with the successful launch of its "XingJie" Large Language Model (XJ LLM), enhancing its AI-driven chronic disease management capabilities [2][3] - The company aims to integrate advanced AI technologies with professional medical services to provide smarter, more accessible, and personalized healthcare solutions [2][8] Company Developments - Fangzhou's XJ LLM has completed the National Generative AI Service Filing, solidifying its leadership in AI-powered chronic disease management [3] - The dual-model architecture, including the XS LLM and XJ LLM, supports comprehensive management across various specialty disease areas, enhancing the AI+H2H ecosystem [5] - The XJ LLM is designed to improve service experience through technological advancements, application transformation, and operational efficiency, enabling natural interactions and autonomous task execution [4] Strategic Partnerships - The company has formed strategic partnerships with leading pharmaceutical firms such as Novo Nordisk, Innovent Biologics, and Fosun Pharma to advance AI-enabled disease management frameworks [7] User Base and Market Position - As of June 30, 2025, Fangzhou serves 52.8 million registered users and 229,000 physicians, positioning itself as a leading online chronic disease management platform in China [9]

Financial Data and Key Metrics Changes - Revenue in H1 was just over JPY 2,200 billion, a decrease of 6.9% or 3.9% at constant exchange rates [11] - Core operating profit was JPY 639.2 billion, a year-on-year decrease of 11.2% at actual FX or 8.8% at constant rates [11] - Reported operating profit declined by 27.7% due to larger impairment losses this fiscal year [11] - Core EPS was JPY 279 and reported EPS was JPY 72, reflecting a 40% decline in reported net profit [11] Business Line Data and Key Metrics Changes - Growth on launch products grew 5.3% at constant exchange rates, representing over 50% of revenue [12] - ENTYVIO grew at 5.1% at constant rates, with a revision of full year forecast for NTDO to 6% at constant exchange rates [12][13] - TAKHZYRO grew steadily with 5.9% growth at constant rates [13] - Immunoglobulin and albumin are expected to grow at high single digits [15] Market Data and Key Metrics Changes - The U.S. market for ENTYVIO is seeing increased active pen patients, but revenue growth has been slightly below expectations [12][13] - The impact of Medicare Part D redesign is affecting several products in the U.S. [14] - The strength of the euro against the Brazilian real is impacting QDenga sales [16] Company Strategy and Development Direction - The company is entering a new business cycle with the Vyvanse generic impact mainly behind it, with potential launches for three new products [7] - The partnership with Innovent Biologics is expected to enhance the oncology pipeline significantly [8][34] - The company is focused on leveraging technology and AI to transform operations [7] Management's Comments on Operating Environment and Future Outlook - Management expects better growth rates for the full fiscal year despite H1 being impacted by loss of exclusivity [22] - The company is committed to maintaining cost discipline while investing for future growth [22] - Management acknowledges the challenges posed by foreign exchange fluctuations, particularly the euro's strength [20][68] Other Important Information - The company has revised its full year guidance for corporate profits and core EPS to reflect unfavorable changes in product mix and transaction FX dynamics [20] - The dividend outlook remains at JPY 200 per share for the full year [21] Q&A Session All Questions and Answers Question: Regarding the Innovent deal and R&D spending - Management emphasized commitment to investment in oncology while managing R&D expenses effectively, with a focus on achieving mid to long-term margins driven by top-line growth [64][66] Question: About the growth rate of ENTYVIO and competitive pressures - Management noted that ENTYVIO remains a market leader but faces intensified competition, particularly in Crohn's disease, impacting growth expectations [93][94] Question: On the gross margin trend and revised guidance - Management explained that the gross margin decline is primarily due to transaction effects and product mix changes, with expectations for lower gross margins in the second half [82][84] Question: About the Innovent partnership and data replicability - Management expressed confidence in the data from the Innovent partnership, noting significant due diligence was conducted to ensure data applicability in global trials [96]

Financial Performance - FY2025 H1 revenue decreased by 69% to JPY 22195 billion[21], a 39% decrease at CER[21] - FY2025 H1 core operating profit decreased by 112% to JPY 6392 billion[21], an 88% decrease at CER[21] - FY2025 H1 adjusted free cash flow increased by 1123% to JPY 5254 billion[21] - Growth & Launch Products increased by 53% at CER in H1[18, 24] - The company maintains broadly flat revenue guidance at CER[18, 36] Pipeline Update - Rusfertide and oveporexton are on track to file within FY2025[18] - Zasocitinib Ph3 psoriasis data is expected in H2[18] - Mezagitamab Ph1b IgAN data show durable eGFR over 18 months[18] - A partnership with Innovent Biologics to bolster the oncology pipeline[18] Oncology Partnership - Takeda entered into a license and collaboration agreement with Innovent Biologics for rights to IBI343 and IBI363, and an exclusive option to license rights to IBI3001, in each case worldwide outside of mainland China, Hong Kong, Macau and Taiwan[12] - IBI363 has demonstrated encouraging data across multiple solid tumor types, with a confirmed objective response rate (cORR) of 367% in sqNSCLC (IO-Refractory) and a median overall survival (mOS) of 153 months at 1/15 mg/kg[80] - IBI343 has shown robust monotherapy activity and a favorable safety profile, with a cORR of ~30% in 2L Pancreatic Cancer (CLDN182 1+/2+/3+ ≥60% expression) and an mOS of 121 months[94]

Summary of Innovent Biologics and Takeda Pharmaceuticals Collaboration Company and Industry Overview - **Company**: Innovent Biologics (1801.HK) - **Partner**: Takeda Pharmaceuticals - **Industry**: Biopharmaceuticals, specifically focusing on oncology and immuno-oncology Key Points and Arguments 1. **Mega Deal Announcement**: Innovent announced a global strategic collaboration with Takeda on IBI363 (PD-1/IL-2α-bias BsAb), IBI343 (CLDN18.2 ADC), and a license option for IBI3001 (EGFR/B7H3 ADC) with a total deal size of **US$11.4 billion** [1] 2. **Financial Breakdown of the Deal**: - Upfront cash payment of **US$1.1 billion** - Upfront equity investment of **US$100 million** at HK$112.56 per share (20% premium) - Development and commercial milestones up to **US$10.2 billion** - Tiered sales royalties up to high-teens from ex-China sales (excluding IBI363 US sales) [1] 3. **Co-Development Agreement**: The agreement includes a **40/60** cost-sharing model for development and commercialization in the US, indicating a strong partnership dynamic [1][2] 4. **Strategic Importance for Takeda**: This deal is noted as Takeda's largest oncology deal, requiring significant R&D investment, which is crucial for balancing its oncology pipeline, particularly with a focus on solid tumors [3][7] 5. **Clinical Development Plans**: - IBI363 focuses on NSCLC (1L, IO-resistant) and CRC (1L/3L) with global phase 3 trials initiated or planned - IBI343 aims to differentiate with fewer GI toxicity, expanding combo opportunities for PDAC and GC [8][9] 6. **Innovent's Growth Strategy**: Innovent management views Takeda as a model for successful globalization, aiming to grow its global team and capabilities by 2030 through this collaboration [2] 7. **Market Positioning**: Innovent is recognized for its strong pipeline of over 30 assets and commercialization capabilities, particularly with its leading PD-1 inhibitor, sintilimab [13] 8. **Investment Rating**: Innovent is rated as a "Buy" with a 12-month price target of **HK$103.22**, indicating a potential upside of **21.1%** from its current price of **HK$85.20** [15] Additional Important Insights - **Takeda's Revenue Contribution**: Oncology accounts for approximately **12%** of Takeda's sales in FY3/25, with the highest year-over-year growth among its segments [10] - **Risks Identified**: Key risks for Innovent include intensifying competition in the PD-1/L1 market in China, uncertain approval timelines for key candidates, and potential restrictions on off-label use due to safety issues [14] This summary encapsulates the critical aspects of the collaboration between Innovent Biologics and Takeda Pharmaceuticals, highlighting the financial implications, strategic importance, and future growth potential within the biopharmaceutical industry.