Core Viewpoint - The Sci-Tech Innovation Board (STAR Market) has successfully created a multi-path listing approach for unprofitable companies, allowing them to access capital markets without the traditional profit threshold, thus facilitating the transformation of R&D capabilities into operational performance and industrial value [1][2]. Group 1: Listing Standards - The STAR Market has five sets of listing standards, with the second to fifth sets not requiring profit, instead focusing on revenue scale combined with various factors such as R&D intensity, cash flow, and market capitalization [2]. - The second to fourth sets cater to "hard technology" companies with strong R&D capabilities, while the fifth set targets innovative companies with leading technologies but no commercialized products yet, based on market capitalization and R&D achievements [2][4]. Group 2: Performance of Unprofitable Companies - Among the 54 unprofitable companies listed, 40% have achieved profitability, with a total revenue of 1,745 billion yuan in 2024, marking a 24% year-on-year increase, and a net loss reduction of 36% [3]. - By the first half of 2025, these companies reported a revenue of 999 billion yuan, an 8% increase year-on-year, with a significant reduction in net loss by 70% [3]. Group 3: Industry Leaders and Innovations - Leading companies like BeiGene and Cambricon have achieved significant milestones, with BeiGene's new cancer drug generating over 10 billion yuan in half-year sales, and Baillie Gifford's ADC drug achieving record overseas licensing deals [3][4]. - In the semiconductor sector, companies like SMIC and Cambrian are driving innovation and breaking foreign monopolies, enhancing the self-sufficiency of the industry [4]. Group 4: Policy Support and Market Dynamics - The introduction of the "1+6" policy and the establishment of the "Sci-Tech Growth Layer" aim to support unprofitable companies in emerging fields like AI and commercial aerospace, balancing innovation support with market risk management [5][6]. - Since the policy's implementation, 15 new IPO applications have been accepted, including four from unprofitable companies, indicating a positive trend in capital market access for innovative firms [6].

Core Insights - The article highlights the significant breakthroughs achieved by innovative pharmaceutical companies listed on the STAR Market, particularly in the context of the 2025 World Lung Cancer Conference, where several companies presented important research findings [1][2]. Group 1: Innovative Drug Approvals - As of now, nine domestic innovative drugs have received FDA approval in the U.S., with four of these coming from STAR Market companies, including BeiGene, Junshi Biosciences, and Dizal Pharmaceuticals [1]. - The STAR Market's registration system is seen as a key factor in identifying high-quality innovative drug companies, with a call for greater tolerance for the volatility exhibited by these firms [1][2]. Group 2: Investment and R&D Growth - Bai Li Tianheng's R&D investment increased from 181 million yuan to 375 million yuan between 2019 and 2022, with R&D expenses rising from 15% to 53% of revenue [3]. - The company successfully went public on the STAR Market in January 2023, benefiting from the market's inclusive listing standards that allow unprofitable companies to list [3][4]. Group 3: Financial Performance and Market Position - Bai Li Tianheng's strategic partnership with Bristol-Myers Squibb for its drug BL-B01D1 resulted in a total transaction value of 8.4 billion USD, marking a record for domestic innovative drug business development [7]. - The company's market capitalization exceeded 100 billion yuan, making it one of the youngest innovative drug companies in the A-share market [8]. Group 4: Clinical Trials and Drug Development - Bai Li Tianheng has over 80 clinical trials ongoing globally for its 15 candidate drugs, with a projected funding gap of 4.819 billion yuan over the next three years [9]. - The company reported a 90.74% year-on-year increase in R&D investment in the first half of 2024, reaching 1.043 billion yuan [8]. Group 5: Capital Market Dynamics - The STAR Market's efficient capital formation mechanism supports drug companies at various stages of development, facilitating a cycle of investment, cultivation, listing, exit, and reinvestment [13]. - The recent regulatory changes have expedited the refinancing process for STAR Market companies, allowing Bai Li Tianheng to raise up to 3.9 billion yuan for R&D projects in a short timeframe [12].

Investment Rating - The report maintains an "Accumulate" rating for the pharmaceutical and biotechnology industry [1] Core Insights - The 2025 World Conference on Lung Cancer (WCLC) highlighted the promising clinical data of domestic lung cancer drugs, particularly the innovative drug iza-bren developed by BaiLi Tianheng, which demonstrated a 100% objective response rate (ORR) in first-line patients with EGFR mutation non-small cell lung cancer (NSCLC) [2][17] - The report suggests a favorable outlook for the pharmaceutical sector, particularly in innovative drugs, research services, and CXO [3][12] Summary by Sections Industry Performance - The A-share pharmaceutical index has seen a year-to-date increase of 26.8%, while the Hang Seng Biotechnology Index has surged by 103.3% [11] - Notable stock performances include Zhend Medical (+41.3%) and Haooubo (+28.0%), while Yuekang Pharmaceutical (-18.4%) and Maiwei Biological (-14.4%) faced significant declines [11] New Drug Developments - Novartis' lung cancer drug, Capmatinib, received approval for a new indication in China, and Johnson & Johnson initiated a Phase III clinical trial for its KLK2/CD3 dual antibody [2] - BaiLi Tianheng's iza-bren showed a 100% ORR in a Phase II study for EGFR mutation NSCLC, with a median progression-free survival (mPFS) of 12.5 months [17][21] Investment Recommendations - The report ranks preferred sub-sectors as follows: innovative drugs > research services > CXO > traditional Chinese medicine > medical devices > pharmacies [3][12] - Specific companies to watch include: - From GLP-1 perspective: BoRui Pharmaceutical, GeLi Pharmaceutical, and XinDa Biologics - From PD-1/VEGF dual antibody perspective: Kangfang Biologics and Shenzhou Cell - From AI drug development perspective: JingTai Holdings and Chengdu XianDao [3][12] Clinical Research Updates - The HARMONi study by Kangfang Biologics showed improved overall survival (OS) with a hazard ratio (HR) of 0.78, indicating a significant benefit for patients, especially in North America [25] - The report emphasizes the ongoing clinical trials for innovative drugs, including the registration Phase III study for iza-bren [20][24]

Core Viewpoint - A Chinese innovative drug, iza-bren, has received breakthrough therapy designations from both the FDA and the Chinese regulatory authority, showcasing its potential in lung cancer treatment with a remarkable objective response rate (ORR) of 100% in clinical trials [3][18]. Group 1: Clinical Data and Breakthroughs - The Phase II clinical trial of iza-bren combined with Osimertinib for EGFR-mutant non-small cell lung cancer (NSCLC) reported an ORR of 100%, the highest recorded for first-line treatments in this category [4][8]. - The trial included 154 patients, with the 2.5 mg/kg dose group showing significant efficacy, leading to the selection of this dosage for future Phase III studies [11][12]. - The median progression-free survival (PFS) rate at 12 months was 92.1%, and the overall survival (OS) rate was 94.8%, indicating strong potential for long-term benefits [10][18]. Group 2: Challenges and Solutions - The drug addresses significant challenges in lung cancer treatment, such as tumor heterogeneity and resistance, with a 100% ORR suggesting a breakthrough in overcoming these issues [9][14]. - The median tumor shrinkage was nearly 57%, indicating substantial tumor reduction, which lays a solid foundation for long-term disease control [9][10]. Group 3: Future Research and Development - The Phase III clinical trial has been initiated, focusing on the efficacy and safety of iza-bren combined with Osimertinib compared to Osimertinib alone, with primary endpoints including PFS and secondary endpoints covering OS and safety [11][12]. - The collaboration with BMS (Bristol-Myers Squibb) is aimed at leveraging their global clinical development expertise to enhance the trial's design and execution [13][20]. Group 4: Market Position and Recognition - Iza-bren has been recognized as a "First-in-class" and "New concept" drug, marking a significant advancement for Chinese innovative pharmaceuticals in the global market [20]. - The drug's breakthrough therapy designations from both the FDA and the Chinese regulatory authority are expected to expedite its development and approval processes, potentially benefiting a large patient population [18][20].

Core Viewpoint - The innovative Chinese drug iza-bren has achieved a 100% objective response rate (ORR) in clinical data presented at the 2025 World Lung Cancer Conference (WCLC), attracting significant global attention from experts [1] Company Summary - Iza-bren is developed by Bai Li Tian Heng and has received one breakthrough therapy designation from the U.S. Food and Drug Administration (FDA) and six from the China National Medical Products Administration [1] - The clinical results indicate that both the combination therapy and monotherapy of iza-bren demonstrate significant efficacy, providing a new "Chinese solution" for lung cancer patients [1] - The chairman of Bai Li Tian Heng, Zhu Yi, stated that this breakthrough signifies a shift in Chinese innovative drugs from "catching up" to "leading," with the potential to reshape the global lung cancer treatment landscape [1]

Core Viewpoint - Baili Tianheng announced the nomination of candidates for the fifth board of directors, including both non-independent and independent directors [2] Group 1: Non-Independent Directors - The board has proposed the nomination of Mr. Zhu Yi, Ms. Zhang Suya, Mr. Zhuo Shi, Mr. Zhu Hai, Mr. David Guowei Wang, and Mr. Wan Wei Li as candidates for non-independent directors [2] Group 2: Independent Directors - The board has also proposed the nomination of Mr. Li Mingyuan, Mr. Xiao Geng, and Mr. Dai Zewei as candidates for independent directors [2]

Core Insights - The drug molecule iza-bren (BL-B01D1) has demonstrated unprecedented clinical results in treating advanced or metastatic EGFR-mutant non-small cell lung cancer (NSCLC), with 94% of patients experiencing tumor shrinkage and a median progression-free survival (PFS) of 12.5 months [4][8][10] - Iza-bren is a first-in-class, innovative dual-target antibody-drug conjugate (ADC) developed by the Chinese company BaiLi Tianheng, which is currently in Phase III clinical trials and has the potential to be a game-changer in cancer treatment [5][12][19] - The drug has received breakthrough therapy designation from both the Chinese National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA) for multiple indications, indicating its significant clinical value [10][11][12] Company Insights - BaiLi Tianheng has successfully retained substantial global rights while partnering with Bristol-Myers Squibb (BMS) for the development of iza-bren, which was licensed for $8.4 billion, reflecting the drug's high potential value [5][16][18] - The company is positioned to become a major player in the global pharmaceutical market, aiming to achieve annual sales of $20 billion for iza-bren, which would place it among the top pharmaceutical companies worldwide [18][20][22] - BaiLi Tianheng is actively developing additional ADCs and has a robust pipeline, indicating its commitment to innovation and long-term growth in the biopharmaceutical sector [23][24]

Investment Rating - The report assigns an "Accumulate" rating to the company [6]. Core Views - The report highlights the promising potential of the company's drug, Iza-bren, in first-line treatment for EGFRm NSCLC, supported by strong clinical data presented at the WCLC conference [3][17]. - The company is expected to see significant revenue growth in the coming years, with projected revenues of 22.66 billion, 23.35 billion, and 12.01 billion yuan for 2025, 2026, and 2027 respectively [13][14]. - The target price for the company's stock is set at 500.68 yuan, reflecting a substantial upside based on the current market conditions [6]. Financial Summary - Total revenue is projected to decline by 20.1% in 2023, followed by a dramatic increase of 936.3% in 2024, before experiencing a significant drop of 61.1% in 2025 [5]. - The net profit attributable to the parent company is expected to be -780 million yuan in 2023, with a recovery to 3.708 billion yuan in 2024, followed by losses in subsequent years [5]. - The earnings per share (EPS) is forecasted to be -1.95 yuan in 2023, improving to 9.25 yuan in 2024, and then declining again in the following years [5]. Clinical Data Highlights - Iza-bren has shown excellent efficacy in clinical trials, with an overall response rate (ORR) of 83.8% and a disease control rate (DCR) of 96.8% in first-line EGFRm NSCLC patients [18][24]. - The combination of Iza-bren and Osimertinib has demonstrated superior results compared to standard therapies, with a 12-month progression-free survival (PFS) rate of 92.1% [21][30]. - In the second-line treatment for EGFRm NSCLC, Iza-bren has shown an ORR of 57% and a median overall survival (OS) of 20.4 months, indicating strong competitive positioning in the market [34][37]. Market Position and Future Outlook - The report anticipates that the company will initiate several pivotal clinical trials in the next 12-18 months, which could further validate the efficacy of Iza-bren and enhance its market position [3][30]. - The competitive landscape for EGFRm NSCLC treatments is evolving, with Iza-bren positioned as a potential new standard of care based on its clinical performance [32][34].

Group 1 - The core viewpoint is that China Merchants Securities has given Sichuan Baili Tianheng Pharmaceutical Co., Ltd. a strong buy initial rating [1]

章程 二〇二五年九月 1 目 录 2 第一章 总则 第二章 经营宗旨和范围 第三章 股份 第一节 股份发行 第二节 股份增减和回购 第三节 股份转让 第四章 股东和股东会 第一节 股东的一般规定 第二节 控股股东和实际控制人 第三节 股东会的一般规定 第四节 股东会的召集 第五节 股东会的提案与通知 第六节 股东会的召开 第七节 股东会的表决和决议 第五章 董事和董事会 第一节 董事的一般规定 第二节 董事会 第三节 独立董事 第四节 董事会专门委员会 第六章 高级管理人员 第七章 财务会计制度、利润分配和审计 3 第一节 财务会计制度 第二节 内部审计 第三节 会计师事务所的聘任 第八章 通知与公告 第一节 通知 第二节 公告 第九章 合并、分立、增资、减资、解散和清算 第一节 合并、分立、增资和减资 第二节 解散和清算 第十章 修改章程 第十一章 附则 第一章 总则 第一条 为适应建立现代企业制度的需要，规范四川百利天恒药业股份有限 公司（以下简称"公司"）的组织和行为，维护公司、股东、职工和债权人的合 法权益，根据《中华人民共和国公司法》（以下简称"《公司法》"）、《中华人民共 和国外商投资法》（以下简 ...