The Stock Exchange of Hong Kong Limited and the Securities and Futures Commission take no responsibility for the contents of this Application Proof, make no representation as to its accuracy or completeness and expressly disclaim any liability whatsoever for any loss howsoever arising from or in reliance upon the whole or any part of the contents of this Application Proof. Application Proof of DIZAL PHARMACEUTICAL CO., LTD. 迪哲(江蘇)醫藥股份有限公司 (the "Company") (A joint stock company incorporated in the People's R ...

Core Viewpoint - The company is shifting its strategy from primarily self-research to integrating external research resources, exemplified by the introduction of the innovative cancer drug ACT001, aiming to accelerate commercialization and enrich its pipeline [1][3]. Group 1: Company Strategy - The company has signed exclusive agreements to obtain the rights for the development, production, and commercialization of ACT001 in specific regions and indications, requiring an initial payment of 100 million RMB and potential milestone payments [1][2]. - The company aims to establish a systematic mechanism for external project introduction, evaluation, and integration, focusing on enhancing its pipeline and accelerating commercialization efforts [3]. Group 2: Drug Development and Clinical Trials - ACT001 is a novel class 1 innovative drug developed by Shangde Pharmaceutical, which has undergone 8 years of preclinical development and 8 years of clinical trials, with over 400 patients participating in exploratory I-II phase clinical trials globally [2]. - ACT001 targets cancer stem cells selectively and can be used in combination with other drugs, making it the first drug in development targeting both STAT3 and NF-κB with favorable safety and pharmacokinetic profiles [2]. Group 3: Market Potential - According to the National Cancer Center, lung cancer is the most prevalent and deadly cancer in China, with approximately 1.0606 million new cases in 2022, representing 22% of all malignancies [4]. - The company estimates that there are over 90,000 new patients with small cell lung cancer brain metastases annually, indicating a significant potential market for ACT001, although pricing remains uncertain [4].

Group 1 - The core point of the news is that Shanghai Haihe Pharmaceutical has been included in the "Star Plan" for the development of pediatric anti-tumor drugs, highlighting its strength in small molecule innovative drug research and development [1][2] - CYH33, a selective PI3Kα inhibitor, targets rare diseases such as PIK3CA-related overgrowth spectrum (PROS) and PIK3CA-related vascular malformations (PRVM), addressing a significant treatment gap for patients [2] - The inclusion of CYH33 in the Star Plan reflects the company's long-term commitment to small molecule innovative drug development, following previous successes with other innovative drugs [2][3] Group 2 - Haihe Pharmaceutical is advancing its value in the market through a comprehensive approach that includes research, clinical trials, commercialization, and internationalization [3] - The innovative drug industry is undergoing structural adjustments, and companies with core technologies and clear clinical value are better positioned to succeed in a competitive environment [3] - The ongoing clinical trials, expansion into overseas markets, and the launch of more pipeline products are expected to drive growth for Haihe Pharmaceutical and contribute to the overall value increase for the Huayi family [3]

Investment Rating - The report maintains a "Buy" rating for the company [2][6]. Core Insights - The approval of the CSF-1R inhibitor, Pimitinib, by the Chinese regulatory authority marks the beginning of a new commercialization journey for the company. This drug is the first self-developed new drug and will be commercialized by Merck [6]. - Pimitinib has shown best-in-class overall response rates (ORR) in clinical trials, with a significant increase from 54% to 76.2% in ORR during a median follow-up of 14.3 months [6]. - The company has multiple ongoing pipeline projects, including the approval of IND for the oral KRAS G12D inhibitor and the completion of the first patient dosing in a clinical trial for the FGFR2/3 inhibitor [6]. Financial Data and Profit Forecast - Revenue projections for the company are as follows: - 2023: 19 million - 2024: 504 million - 2025E: 612 million - 2026E: 756 million - 2027E: 627 million - The net profit attributable to ordinary shareholders is expected to be: - 2023: -432 million - 2024: 28 million - 2025E: 63 million - 2026E: 151 million - 2027E: 133 million - The projected earnings per share (EPS) are: - 2023: -0.67 - 2024: 0.04 - 2025E: 0.09 - 2026E: 0.22 - 2027E: 0.20 [3][7].

Core Insights - The collaboration between Fosun Pharma and Pfizer marks a significant milestone in the competitive landscape of GLP-1 therapies, highlighting Fosun's innovative capabilities in small molecule drug development [3][8][10] Group 1: Transaction Details - On December 9, Fosun Pharma announced a licensing agreement with Pfizer for its orally administered small molecule GLP-1 receptor agonist YP05002, granting Pfizer global rights for development, production, and commercialization [4][5] - Fosun Pharma will receive an upfront payment of up to $150 million, with potential milestone payments totaling up to $1.935 billion, along with tiered royalties post-approval [4][5] Group 2: Market Context - The GLP-1 market is experiencing intense competition, with major pharmaceutical companies actively pursuing next-generation therapies. Sales of existing GLP-1 products like semaglutide and tirzepatide have reached $25.462 billion and $24.837 billion respectively in the first three quarters of the year, indicating a strong market demand [6][7] - The collaboration signifies Fosun Pharma's recognition in the global market, as it aligns with the trend of multinational corporations seeking innovative GLP-1 solutions [5][6] Group 3: Strategic Implications - Fosun Pharma's chairman emphasized that this partnership is a key step in the company's strategy for innovation and internationalization, aiming to address unmet clinical needs in obesity and metabolic diseases [5][8] - The deal is part of a broader trend where Fosun Pharma has secured multiple business development transactions in 2023, totaling approximately $4 billion, showcasing its diverse research capabilities [9][10]

Core Viewpoint - Harmony Biosciences has received approval for its IPO application on the Hong Kong Stock Exchange, with its prospectus now publicly available [1]. Company Overview - Harmony Biosciences was established in 2002 and focuses on developing small molecule innovative drugs for autoimmune diseases and tumors. The company has a pipeline that includes seven innovative drugs, with the lead candidate being the PDE4B inhibitor Mufemilast, which has already been approved for market [3][10]. - The pipeline also includes TNFα inhibitor Hemay007, IgE/PDE4 inhibitor Hemay808, and EGFR/HER2 inhibitor Hemay022, among others [3]. Financial Information - The company has undergone multiple rounds of financing, with the latest being a Series E round completed in December 2024, raising 118 million RMB, resulting in a pre-money valuation of 3.8 billion RMB and a post-money valuation of 3.918 billion RMB [3]. Drug Pipeline Details - Mufemilast is the first domestically produced PDE4B inhibitor, showing potential for treating various autoimmune diseases. The company also has several differentiated small molecule new drugs targeting autoimmune diseases and tumors, with expectations for further clinical progress [10]. - The drug pipeline includes: - Mufemilast® (PDE4B) for moderate to severe plaque psoriasis and other autoimmune conditions [5]. - Hemay007 (TNFα) for moderate to severe rheumatoid arthritis [5]. - Hemay808 (IgE/PDE4) for mild to moderate atopic dermatitis [5]. - Hemay022 (EGFR/HER2) for late-stage ER+/HER2+ breast cancer [5]. Market Context - The company is positioned within a competitive landscape of PDE4 inhibitors, with several products already approved in China, indicating a growing market for these types of treatments [11].

Financial Performance - In the first nine months of 2025, the company achieved revenue of CNY 3.624 billion, a year-on-year increase of 6.23% [1] - Net profit attributable to the parent company was CNY 1.033 billion, up 6.08% year-on-year [1] - Revenue breakdown: - Traditional Chinese medicine: CNY 1.138 billion, up 8.72% [1] - Chemical drugs: CNY 441 million, down 14.21% [1] - Biological drugs: CNY 2.040 billion, up 11.36% [1] R&D Progress - KH902-R10 (high-dose Conbercept for diabetic macular edema) is in Phase II clinical trials [2] - Gene therapy products KH631 and KH658 (for neovascular age-related macular degeneration) are in Phase II in China and Phase I in the U.S. [2] - KH617 (for advanced solid tumors) is in Phase II [2] - Antibody-drug conjugate KH815 (for various advanced solid tumors) is in Phase I in China and Australia [2] - Traditional Chinese medicine KH110 (for Alzheimer's disease) is in Phase III [2] - Small molecule innovation drug KH607 (for depression) is in Phase II [2] Market Insights - The global market for nAMD drugs is expected to become more competitive, with anti-VEGF drugs remaining mainstream [3] - The U.S. market holds a significant share, with China ranking second in terms of market size [3] - The company aims to leverage its product lineup to meet diverse clinical needs in the ophthalmology sector [3] Future Plans - The company will focus on chronic diseases, including cardiovascular, central nervous system, metabolic, and oncology areas for innovative R&D [4] - Plans to expand the pipeline in oncology with antibody conjugates and small molecule drugs [5] - The company anticipates a revenue and net profit growth of 5%-15% for 2025 compared to 2024 [4] Competitive Landscape - Conbercept is currently a leader in the domestic anti-VEGF market [4] - The company plans to enhance its product line with high-concentration Conbercept expected to be approved by 2028 [7] - The company is committed to optimizing drug delivery methods and addressing unmet clinical needs through innovative research [4]

Group 1 - The core viewpoint is that He Yu-B (02256) is a leader in small molecule innovative drugs, with projected revenues of RMB 650 million, 680 million, and 730 million for 2025-2027, and net profits of RMB 97 million, 111 million, and 142 million respectively, leading to a target price of HKD 22.06, indicating a potential upside of 48.5% from the current price [1] Group 2 - Global BIC product Pimiatin has shown excellent data at ESMO, with an overall response rate (ORR) of 76.2% in the III phase MANEUVER study for patients with giant cell tumor of the tendon sheath, and a significant improvement in joint activity by 23.9% compared to baseline [2] - The NDA for Pimiatin has been submitted domestically, and the FDA NDA submission is progressing, expected to be submitted in Q4 2025 [2] - Pimiatin is also advancing in a II phase study for treating chronic graft-versus-host disease [2] Group 3 - The development of innovative drugs is accelerating, with the oral PD-L1 inhibitor ABSK043 and the KRASG12C inhibitor from Ailis receiving IND approval for treating KRASG12C mutated non-small cell lung cancer (NSCLC) patients [3] - The single-agent treatment of Ipagotin for advanced hepatocellular carcinoma (HCC) has commenced, with the first patient dosed in June 2025, targeting a population with poor prognosis due to FGF19 overexpression [3] - A novel targeted therapy approach for HCC is being developed, with a II phase study showing an ORR of ≥50% and a progression-free survival (PFS) of ≥7 months when combined with Atezolizumab [3]

Group 1 - The core viewpoint is that He Yu-B (02256) is a leading player in small molecule innovative drugs, with projected revenues of RMB 650 million, 680 million, and 730 million for 2025-2027, and net profits of RMB 97 million, 111 million, and 142 million respectively, leading to a target price of HKD 22.06, indicating a potential upside of 48.5% from the current price [1] Group 2 - Global BIC product Pimiatin has shown excellent data at ESMO, with an overall response rate (ORR) of 76.2% in the III phase MANEUVER study for patients with giant cell tumor of the tendon sheath, and a significant improvement in joint activity by 23.9% compared to baseline [2] - The NDA for Pimiatin has been submitted domestically, and the FDA NDA submission is progressing, expected to be submitted in Q4 2025 [2] - Pimiatin is also advancing in a Phase II study for treating chronic graft-versus-host disease [2] Group 3 - The development of innovative drugs is accelerating, with the oral PD-L1 inhibitor ABSK043 and the KRASG12C inhibitor from Ailis receiving IND approval for treating KRASG12C mutated non-small cell lung cancer (NSCLC) patients [3] - The single-agent treatment of Ipagotini for advanced hepatocellular carcinoma (HCC) is underway, with the first patient dosed in June 2025, targeting a population with poor prognosis due to FGF19 overexpression [3] - A novel targeted therapy approach for HCC is being developed, with a Phase II study showing an ORR of ≥50% and a progression-free survival (PFS) of ≥7 months when combined with Atezolizumab [3]

Market Performance - The pharmaceutical and biotechnology index rose by 0.35% from October 20 to October 24, underperforming the Shanghai Composite Index by 0.36 percentage points, marking five consecutive weeks of underperformance [1] - The innovative drug index (BK1106) saw a slight increase of 0.03%, ending a four-week decline [1] - The Hang Seng Healthcare Index fell by 0.77%, although the decline was less severe than the previous week, indicating a continued downward trend [1] - The Hong Kong innovative drug ETF (513120) decreased by 2.82%, failing to capitalize on positive news from the ESMO conference and significant business development transactions by Innovent Biologics [1] IPO Developments - Jiangxi Biological Products Research Institute Co., Ltd. has submitted a new application for listing on the Hong Kong Stock Exchange, following a failed attempt in April 2023 [2] - Jiangxi Biological is the largest provider and exporter of human tetanus antitoxin (TAT) in China, holding a global market share of 36.6% and a domestic market share of 65.8% in 2024 [2] - The company's revenue is relatively low, projected at 221 million yuan in 2024 and 99.7 million yuan in the first half of 2025, primarily due to the low price of TAT, which averages 3.6 yuan per unit for exports, about 30% of the domestic price [2] Clinical Trials - From October 20 to October 26, the National Medical Products Administration disclosed 95 new clinical trial registrations, with 30 of these being innovative drugs in Phase II or higher, mainly in oncology, cardiovascular, and dermatology fields [6] Drug Approvals - Three small molecule innovative drugs were approved last week, including a PDE4B inhibitor for idiopathic pulmonary fibrosis (IPF), marking the first successful approval for IPF treatment in nearly a decade [9] - The drug, developed by Boehringer Ingelheim, achieved its primary endpoint in Phase III trials and was approved in both the U.S. and China within two weeks [9] - Other approved drugs include a first-line treatment for advanced non-small cell lung cancer (NSCLC) and a new oral hypoglycemic agent for type 2 diabetes [10][11] Company Performance - Huahao Zhongtian Pharmaceutical-B has seen a cumulative decline of over 33% in the past two weeks, attributed to low trading volumes and a general downturn in the innovative drug sector [12] - The company reported a revenue of 14.78 million yuan in the first half of the year, a decrease of 55.36% year-on-year, with a net loss of 54.04 million yuan, slightly improved from the previous year's loss [12]