Investment Rating - The report maintains an investment rating of "Leading the Market-B" for the chemical pharmaceutical industry [1]. Core Viewpoints - The report highlights the promising clinical efficacy and safety profile of BGB-43395, a CDK4 inhibitor developed by BeiGene, which shows potential as a best-in-class treatment for HR+/HER2- metastatic breast cancer [3][5]. - The global market for CDK4/6 inhibitors is substantial, projected to reach approximately $13 billion by 2024, indicating significant growth potential in this therapeutic area [5]. Summary by Sections Industry Performance - The chemical pharmaceutical industry has shown strong market performance over the past year, with a focus on innovative drug developments [1]. Drug Development Insights - BGB-43395 demonstrates high selectivity and inhibition of CDK4, with a favorable safety profile compared to existing CDK4/6 inhibitors [3][4]. - The drug is set to enter Phase III trials for HR+/HER2- metastatic breast cancer, with the second-line study expected to start in Q4 2025 [3]. Clinical Trial Results - Initial results from clinical trials indicate that BGB-43395, when combined with fulvestrant, shows preliminary anti-tumor activity in patients with solid tumors, particularly breast cancer [5][6]. - The overall response rate (ORR) for evaluable breast cancer patients was reported at 11% [5]. Market Context - The report emphasizes the challenges faced by current CDK4/6 inhibitors, including hematological toxicity and off-target effects, which BGB-43395 aims to address [5].

Group 1: Report Overview - The research object is Gongtong Pharmaceutical Co., Ltd., belonging to the chemical pharmaceutical industry, and the reception time was on June 12, 2025 [16]. - The participants in the research include investors who participated in the "2025 Online Collective Reception Day for Investors of Listed Companies in Hubei Province" [19]. Group 2: Company's Market Position and Strategy - In the field of steroid drug starting materials, the company has achieved large - scale production of a full range of products such as 4 - androstenedione (4 - AD), androstadienedione (ADD), 9 - hydroxyandrostenedione (9 - OH - AD), 11 - hydroxy - AD, and dihydroxyalcohol, with its production capacity scale and product variety diversity ranking among the top in the world; in the intermediate field, it has built a vertically integrated system covering the entire steroid drug industry chain and has become an important R & D and production base for steroid drug intermediates in China; in the API field, relying on the API project of its subsidiary Huahai Gongtong, it will become the first integrated supplier in China to simultaneously layout sex hormones, progestogens, corticosteroids, and other types of steroid APIs, realizing the full - chain connection from starting materials to APIs [23]. - To face market competition, the company adheres to innovation - driven development, with its product strategy focusing on three directions: deepening the integration of biotransformation and synthetic biology technologies through technological iteration to reduce the production cost of key intermediates; optimizing the automation level of existing production lines through capacity expansion to increase the proportion of high - value - added product production capacity; and continuously exploring the market, consolidating strategic cooperation with global leading pharmaceutical companies, and expanding the layout of intermediates in emerging fields such as anti - cancer and assisted reproduction [23]. Group 3: R & D - related Information - The Hubei Gongtong Steroid Research Institute, established over three years ago, aims to break through four core technologies: targeted screening of strains, targeted modification of enzyme engineering, efficient conversion of sterols, and green synthesis processes, and form a closed - loop innovation system from basic research to industrial transformation. Its technological achievements have won many authoritative certifications such as the National Science and Technology Progress Award [24][25]. - From 2022 to 2024, the company's R & D investments were 45.15 million yuan, 38.10 million yuan, and 51.08 million yuan respectively, and the proportion of R & D investment in operating income has been increasing year by year. The company has established a special R & D center to promote the R & D of new products and processes and the upgrading and optimization of existing processes [25]. Group 4: Overseas Market and Other Business Information - In 2024, the company's overseas sales accounted for 28.54%, and the proportion has been increasing year by year. In 2025, the company will continue to adhere to the international development strategy, strengthen brand promotion overseas and increase sales channels by establishing subsidiaries overseas, and seek business cooperation through overseas resources [25]. - The vitamin D3 industrialization project has been filed and is being implemented according to the company's project plan [27]. - Regarding the company's share repurchase, the period is within 12 months from the date of the board of directors' review. The company will promote the repurchase work according to market conditions and disclose the repurchase progress as of the end of the previous month at the beginning of each month [27]. - For specific information on innovative drugs such as fluvestrant, it shall be subject to the information disclosed on the company's designated information disclosure website; for the follow - up plan of convertible bonds, it shall be subject to the company's announcements; and for the question of whether the company's losses in the first half of the year will increase year - on - year after the capitalization of the raised projects, it is necessary to refer to the semi - annual report of 2025 [25][27]

Core Insights - The approval of Truqap® (capivasertib) in combination with fulvestrant for the treatment of adult patients with HR-positive, HER2-negative breast cancer with specific genetic alterations marks a significant advancement in targeted therapy options for this patient population [1][3]. Group 1: Approval and Study Results - The approval is based on positive results from the global phase III CAPItello-291 study, which showed that capivasertib combined with fulvestrant reduced the risk of disease progression or death by 50% in patients with PIK3CA/AKT1/PTEN alterations compared to fulvestrant alone [3]. - In the Chinese cohort, the combination therapy demonstrated a 59% reduction in disease progression or death risk for patients with PIK3CA, AKT1, or PTEN gene alterations compared to fulvestrant monotherapy [3]. Group 2: Breast Cancer Statistics and Treatment Landscape - Breast cancer is the most common malignant tumor among women in China, with HR-positive breast cancer accounting for 70% of cases globally [4]. - Approximately 50% of HR-positive advanced breast cancer patients carry alterations in PIK3CA, AKT1, or PTEN genes, with this figure rising to 57% in the Chinese population [4]. - The presence of these genetic alterations often leads to resistance against standard endocrine therapies, highlighting the need for combination treatment strategies to enhance therapeutic efficacy [4]. Group 3: Expert Commentary - Professor Hu Xichun, a leading researcher in the CAPItello-291 study, emphasized the importance of this approval as it provides a new treatment option for patients with advanced HR-positive breast cancer who have specific genetic alterations, potentially extending survival and improving disease management [5].

Core Insights - AstraZeneca announced the approval of Capivasertib (brand name: QianKede) in China for the treatment of locally advanced or metastatic breast cancer in adult patients with HR-positive, HER2-negative tumors and specific genetic alterations [1][2] - This approval is based on positive results from the global Phase III CAPItello-291 study, which showed that Capivasertib combined with Fulvestrant significantly reduces the risk of disease progression or death in patients with PIK3CA/AKT1/PTEN alterations [1][2] Summary by Sections - **Approval Details** - Capivasertib is the first and only AKT inhibitor approved in China for the specified indication [1] - The approval follows positive results from the CAPItello-291 study published in the New England Journal of Medicine [1] - **Clinical Study Results** - In the global population, 69% of patients had previously received CDK4/6 inhibitors [2] - Capivasertib combined with Fulvestrant reduced the risk of disease progression or death by 50% compared to Fulvestrant alone in patients with relevant biomarkers [2] - In the Chinese cohort, the combination therapy reduced the risk by 59% for patients with PIK3CA, AKT1, or PTEN alterations [2] - **Clinical Implications** - The approval provides a new treatment option for patients with advanced HR-positive breast cancer who have developed resistance to initial endocrine therapy [2] - It highlights the importance of precision medicine in breast cancer treatment [2]

智通财经APP讯，四环医药(00460)发布公告，本集团旗下非全资附属公司轩竹生物科技股份有限公司 (轩竹生物)研发的创新药吡洛西利(Bireociclib)取得了重大科研突破，其联合氟维司群治疗HR+/HER2-晚 期乳腺癌临床III期研究( BRIGHT-2，NCT05077449)期中分析结果，已正式刊登于顶级期刊Nature子刊 《Nature Communications》。 BRIGHT-2研究是由中国医学科学院肿瘤医院徐兵河院士牵头开展的随机双盲 III期试验。该试验聚焦中 国乳腺癌患者，他们普遍诊断年龄小、分期晚，Luminal B型比例高，晚期化疗应用多，复发风险大。 研究从国内64个中心招募305例经内分泌治疗后进展的HR+/HER2-晚期乳腺癌患者。这些患者中位年龄 55岁， 37.0%绝经前，68.2%有内脏转移，25.6%原发耐药，23.9%晚期接受过化疗，91.5% 在治疗期病 情进展，整体病情复杂棘手。 在此次试验里，吡洛西利联合氟维司群疗效显著。中位随访8.7个月时，联合组中位PFS达12.94个月， 远超氟维司群组的7.29个月。各亚组患者均有PFS获益，尤其是内分泌原发耐药 ...