Group 1 - The core patent of Dongyangguang Pharmaceutical's invention "Bridge cyclic compound as a hepatitis C inhibitor and its preparation method" has won the second Hubei Patent Gold Award, highlighting the company's innovation and core competitiveness in new drug development [1][5][12] - The hepatitis C virus (HCV) infection rate in China is approximately 10 million, with new reported cases around 200,000 per year, indicating a significant public health challenge due to low diagnosis and treatment rates [6][7] - Dongyangguang Pharmaceutical established its research goal in 2010 to develop hepatitis C drugs tailored for the Chinese market, aiming to provide effective treatment options for the large patient population [6][7] Group 2 - The drug, Phosphoric acid imetavine, was developed over ten years and became the first domestically developed hepatitis C NS5A inhibitor in China, receiving approval in 2020 [7][8] - Phosphoric acid imetavine has a high overall cure rate of 99.8% when used in combination with Sofosbuvir, and it was included in the national medical insurance directory in December 2021, significantly reducing the cost for patients [7][8] - The patent strategy for Phosphoric acid imetavine includes a comprehensive layout that began in 2013 and has expanded to cover various aspects of the drug, enhancing its market competitiveness and protecting its innovations [10][11] Group 3 - Since its establishment in 2001, Dongyangguang Pharmaceutical has focused on R&D, applying for over 2,400 invention patents and holding more than 1,400 authorized patents, making it a leader in patent filings among domestic pharmaceutical companies [12] - The company has built a complete innovation chain from basic research to clinical transformation, with 150 approved drugs globally and over 100 in development, including nearly 50 first-class innovative drugs [12] - Dongyangguang Pharmaceutical aims to continue driving development through innovation, enhancing its core competitiveness, and contributing to the high-quality development of the pharmaceutical industry [12]

Core Insights - The company has made significant progress in the development of its innovative drug SYN045, which has received approval for Phase I clinical trials in three different dosages from the National Medical Products Administration of China [1] - The results from the completed clinical trials indicate favorable pharmacokinetic characteristics, enhanced safety, and tolerability compared to similar drugs, supporting the potential for long-term oral administration [1] - The company has submitted a total of 18 invention patents related to the SYN045 project, including 5 international patents and 13 domestic patents, with some already granted [1] Group 1: SYN045 Development - SYN045 is a highly selective PGI2 receptor agonist showing significant anti-pulmonary arterial hypertension effects in animal studies [1] - The company plans to conduct Phase IIa clinical trials based on the final results of Phase I to determine the dose-response relationship and explore efficacy and safety in patients [1] Group 2: Other Drug Developments - The company is developing an innovative anti-epileptic drug targeting the potassium ion channel KCNQ2/3, currently in the compound screening phase and preparing for toxicity evaluation [2] - An innovative drug for diabetic peripheral neuropathic pain is also under development, targeting AAK1, with compound screening currently underway [2] - The company is working on three new drug reformulation projects, with two completing pharmacokinetic-based formulation studies and one planned for IND submission within the year [2]

Investment Rating - The report maintains an investment rating of "Outperform the Market - A" for the biopharmaceutical sector [7]. Core Insights - The National Healthcare Security Administration has initiated the adjustment work for the 2025 National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance Drug Catalog, which is expected to include multiple new drugs for negotiation [2]. - From July 1, 2024, to June 30, 2025, approximately 19 oncology drugs and 23 non-oncology drugs are anticipated to be approved and may participate in the 2025 medical insurance negotiations [2]. Summary by Sections 1. Weekly New Drug Market Review - From June 30, 2025, to July 4, 2025, the top five companies in the new drug sector by stock price increase were: - Zai Lab (45.00%) - Sanofi (36.30%) - Frontier Biopharma (30.60%) - Micron Biomedicine (30.50%) - Kangfang Biopharma (25.50%) - The top five companies with the largest declines were: - Oconview (-12.90%) - Kexin Pharmaceuticals (-9.10%) - Dongyao Pharmaceuticals (-6.70%) - Lepu Biopharma (-6.40%) - Yifang Biopharma (-3.60%) [1][16]. 2. Weekly New Drug Industry Analysis - The adjustment work for the 2025 medical insurance catalog has begun, allowing new generic drugs approved between January 1, 2020, and June 30, 2025, to apply for inclusion [2]. - The expected new drugs for negotiation in 2025 will primarily be those approved between July 1, 2024, and June 30, 2025 [2]. 3. Weekly New Drug Approval & Acceptance Status - This week, 22 new drugs or new indications received approval for market entry, while one new drug application was accepted [3][26]. 4. Weekly New Drug Clinical Application Approval & Acceptance Status - A total of 46 new drug clinical applications were approved this week, and 31 new drug clinical applications were accepted [4][32]. 5. Key Domestic Market Events - Key events included the approval of a MET inhibitor by Hutchison China MediTech for treating advanced non-squamous non-small cell lung cancer and the approval of an anti-IL-1β monoclonal antibody by Junshi Biosciences for treating acute attacks of gouty arthritis [5][12]. 6. Key Overseas Market Events - Notable overseas events included Moderna's positive progress in its seasonal flu mRNA vaccine study, Regeneron's accelerated approval of a dual antibody for multiple myeloma, and Pfizer's announcement of a significant reduction in bleeding rates in hemophilia patients [13].

香 港 交 易 及 結 算 所 有 限 公 司 及 香 港 聯 合 交 易 所 有 限 公 司 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 或任何部份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。 Laekna, Inc. 來凱醫藥有限公司 （於開曼群島註冊成立之有限公司） （股份代號：2105） 自願公告 LAE103向美國食品藥品監督管理局(FDA) 遞交新藥臨床試驗(IND)申請 本 公 告 由 來 凱 醫 藥 有 限 公 司（「 本 公 司 」， 連 同 其 附 屬 公 司 統 稱「 本 集 團 」）自 願 作 出，以告知本公司股東及潛在投資者本集團最新業務進展。 關於LAE103 LAE103是一款Act RIIB選擇性抗體。本集團正積極推動該候選藥物進入臨床研究 階段，旨在為肌少性肥胖症及肌肉相關疾病提供創新療法。 – 1 – 風險提示 LAE103最終不一定能夠成功開發及商業化。本公司股東及潛在投資者於買賣本公 司證券時務請審慎行事。 公司董事（「董事」）會（「董事會」）欣然宣佈，本集團已就自主研發的LAE103（ 一 ...

Group 1: Company Overview - The company achieved a revenue of 72.11 million yuan in 2024, representing a year-on-year growth of 20.8%, while the net profit attributable to shareholders was -45.18 million yuan, a reduction in losses compared to the same period in 2023 [1] - In Q1 2025, the company reported a revenue of 16.42 million yuan, a year-on-year increase of 1.85%, with a net profit of -0.77 million yuan, marking a 37.01% reduction in losses compared to the previous year [1] - The company has not yet launched any new drugs, but its ophthalmic products are the core revenue source, continuously supporting new drug development [1] Group 2: Clinical Progress - The company's NL003 project, a recombinant human hepatocyte growth factor naked plasmid injection, has made significant progress, with both the ulcer group and resting pain group of the Phase III clinical trials completing unblinding [2] - The primary endpoint of the NL003 resting pain group showed a significant improvement over the placebo group, with a p-value of less than 0.0001, indicating statistical significance [2] - NL003 successfully passed registration inspection in September 2024, with its production process meeting GMP standards, establishing a stable and controllable production and quality management system [2] Group 3: Production and Commercialization - The company's biopharmaceutical industrialization project in Tongzhou, Beijing, has achieved important milestones, including the completion of municipal power capacity approval and design for various facilities [3] - The completion of this project is expected to significantly enhance the company's production capacity in the biopharmaceutical field, providing strong support for the commercialization of innovative drugs [3] - In October 2024, the company opened a branch in Shanghai, further facilitating its commercialization efforts [3] Group 4: Financial Forecast - The company forecasts revenues of 88 million yuan, 185 million yuan, and 371 million yuan for 2025, 2026, and 2027 respectively, with corresponding EPS of -0.19, -0.01, and 0.30 yuan [4] - The current stock price corresponds to PE ratios of -114.7, -2402.2, and 70.6 times for the years 2025, 2026, and 2027 respectively, with an initial coverage rating of "buy" [4]

Core Viewpoint - Jiangsu Aidi Pharmaceutical Co., Ltd. is adjusting its fundraising investment projects to enhance the efficiency of fund usage and expedite the development of advantageous projects, specifically by reallocating funds from the "Ustectidine New Indication Research Project" to the "Integrase Inhibitor Drug Research and Clinical Study Project" [4][8][14] Fundraising Investment Project Overview - As of June 20, 2025, the raw material drug production research and supporting facilities project has been completed, while other fundraising projects are ongoing [2] - The total amount of committed investment for the projects is 542.8 million yuan, with 396.6 million yuan invested by June 20, 2025 [3] Changes and Amount Adjustments - The company plans to change the name of the project "Ustectidine New Indication Research Project" to "Integrase Inhibitor Drug Research and Clinical Study Project" and adjust the investment amounts accordingly [4][5] - The remaining funds of 84.3699 million yuan from the original project will be fully allocated to the new project to meet its funding needs [6][9] Reasons for Changes - The original project faced delays due to stricter regulatory requirements and the need for further evaluations, prompting the company to reallocate funds to a project with more immediate needs [7][8] - The "Integrase Inhibitor Drug Research and Clinical Study Project" is crucial for the company's pipeline, aiming to develop a new generation of integrase inhibitors for HIV treatment [9][10] Impact of Changes - The adjustments are expected to improve the efficiency of fund usage and support the company's long-term development strategy without adversely affecting normal operations [12][14] - The project aims to enhance the effectiveness and safety of HIV treatments, aligning with national policy goals and expanding the company's product offerings [10][12] Approval Process - The board of directors and the supervisory board have approved the changes, which will be submitted for shareholder approval [13][14]

Core Viewpoint - Yifang Biotech (688382.SH) reported a revenue of 169 million yuan for 2024, a year-on-year decrease of 9.02%, while the net loss attributable to shareholders was 240 million yuan, a reduction in loss of 15.41% [1] Financial Performance - The company’s revenue heavily relies on technology licensing and sales commissions, with 96% of revenue coming from these sources [1] - Milestone revenue from Gexolex (格索雷塞) accounted for 151 million yuan (89% of total revenue), while sales commissions from Beifutini (贝福替尼) contributed 16.38 million yuan (9.7%) [1] - The company reported that the revenue from milestone payments is one-time income, leading to significant fluctuations in annual revenue, thus the gross margin is reported as "not applicable" [1] Accounts Receivable - The overdue receivables amount to 180 million yuan, which are milestone payments from Betta Pharmaceuticals (贝达药业) [2] - Betta Pharmaceuticals has delayed the payment due to its own financial arrangements but has committed to fulfilling its payment obligations as per the agreement [2] - Yifang Biotech has made a provision for bad debts of 18 million yuan against the overdue amount, which is considered sufficient [2] Research and Development - R&D investment for 2024 was 384 million yuan, a decrease of 13.22% year-on-year, with a reduction of 36 R&D personnel [2] - The reduction in personnel was attributed to the completion of clinical trials for D-1553 (Gexolex), and the adjustments did not affect key positions or the overall R&D capability of the company [2] Business Outlook - The company has indicated potential risks related to ongoing losses and significant declines in performance, with most products still in clinical development and not yet generating sales revenue [3] - Future profitability is expected to improve as clinical development and commercialization progress, leading to milestone payments and sales sharing [3]

Investment Rating - The industry rating is neutral, indicating that the overall return is expected to be between -5% and 5% relative to the CSI 300 index over the next six months [9]. Core Insights - The pharmaceutical sector experienced a slight increase of +0.41% on June 25, 2025, underperforming the CSI 300 index by 1.03 percentage points, ranking 23rd among 31 sub-industries in the Shenwan classification [4]. - Among sub-industries, medical consumables (+1.34%), medical devices (+1.24%), and hospitals (+1.23%) performed well, while offline pharmacies (-0.10%), blood products (+0.10%), and in vitro diagnostics (+0.12%) lagged behind [4]. - AstraZeneca's two new drugs, AZD6234 and AZD9550, received clinical trial approval in China for long-term weight management in overweight or obese adults with at least one obesity-related comorbidity [5]. Summary by Sections Market Performance - On June 25, 2025, the pharmaceutical sector's performance was +0.41%, underperforming the CSI 300 index by 1.03 percentage points [4]. - The top three gainers were Huachang Technology (+13.48%), Shuyuan Pingmin (+6.80%), and Huitai Medical (+6.07%), while the top three losers were Yiming Pharmaceutical (-8.56%), Yong'an Pharmaceutical (-7.87%), and Beilu Pharmaceutical (-7.35%) [4]. Industry News - AstraZeneca's AZD6234 is a long-acting insulin receptor agonist approved for clinical trials in China, while AZD9550 is a synthetic GLP-1/glucagon dual receptor agonist, marking its first clinical approval in China [5]. - Yifan Pharmaceutical announced the approval for clinical trials of its biosimilar insulin injection [6]. - Shenzhou Cell and Hanyu Pharmaceutical also received approvals for their respective clinical trials and drug listings [6].

Core Viewpoint - The article discusses the significant progress of AI-driven drug Rentosertib, which has shown promising results in clinical trials for idiopathic pulmonary fibrosis, marking a potential breakthrough in AI drug development [3][4][5]. Group 1: Clinical Trial Results - The 2a phase clinical trial of Rentosertib demonstrated a mean increase in forced vital capacity (FVC) of 98.4 milliliters for patients, while the control group experienced a decrease of 20.3 milliliters, indicating a substantial improvement in lung function [6][8]. - The trial involved 71 patients across 22 research centers in China, with various treatment regimens, confirming the drug's potential to reverse disease progression [7][8]. - Rentosertib is the first AI drug to achieve conceptual validation, with plans to advance to phase 3 clinical trials in China [4][5]. Group 2: Drug Development Process - The discovery of Rentosertib involved AI-driven data mining and analysis, identifying TNIK as a novel target, which is linked to various diseases beyond pulmonary fibrosis [12][14]. - The company utilized its AI platform, PadnaOmics, to generate a list of 20 potential drug targets, with TNIK being prioritized based on novelty and druggability [13]. - The AI-generated candidate, Rentosertib, is positioned to be the first clinical TNIK inhibitor if approved [12][13]. Group 3: Industry Context and Challenges - The AI drug development sector faces challenges, including funding constraints and the high failure rate of new drug approvals, with current success rates around 7.5% [16][22]. - Despite the promising results of Rentosertib, the company must navigate the complexities of clinical trials and regulatory approvals, particularly in the U.S. market, where competition is fierce [21][22]. - The company has raised approximately $123 million in its latest funding round, which will support further development and innovation in its drug pipeline [20][21].

Core Insights - The clinical data for Aosheng Pharmaceutical's core product, Orebatinib, presented at the EHA annual meeting indicates its potential to improve long-term outcomes for patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) through various combination therapies [1] - Aosheng Pharmaceutical's APG-2575 showed promising results in treating myeloid malignancies, enhancing its commercial prospects against competitors like Venetoclax [2] - The company is expected to experience rapid revenue growth due to the sales ramp-up of Orebatinib and potential payments from Takeda, with revenue forecasts for 2025-2027 indicating significant increases [3] Group 1: Orebatinib Clinical Data - Orebatinib combined with Belinostat in a single-arm clinical trial for Ph+ or Ph-like ALL showed a median follow-up of 17 months, with a complete response (CR) rate of 100% after one treatment cycle and an overall survival (OS) rate of 100% at 18 months [1] - In the Orebatinib combined with VP regimen for adult Ph+ ALL, the overall response rate (ORR) was 100%, with a CR rate of 97.3% and a 2-year OS rate of 96.3% [1] Group 2: APG-2575 Clinical Data - The ASCO annual meeting revealed that APG-2575 combined with Azacitidine in a clinical study for previously treated or untreated myeloid malignancies had an ORR of 31.8%, with 4.6% of patients achieving a partial response (PR) [2] - The data suggests that APG-2575 may have a competitive edge over Venetoclax, particularly in differentiated indications, and the company is also exploring potential markets in MDS and MM [2] Group 3: Revenue Forecast and Investment Outlook - The company anticipates rapid revenue growth, maintaining revenue forecasts of 519 million yuan and 3.215 billion yuan for 2025 and 2026, respectively, with an additional forecast of 2.095 billion yuan for 2027 [3] - The strong growth outlook is supported by the overseas market potential and the expected sales increase of Orebatinib, leading to a "buy" rating for the stock [3]