Core Viewpoint - Northeast Pharmaceutical's subsidiary, Beijing Dingcheng Peptide Source Biotechnology Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of DCTY0801 injection, marking a significant milestone in the product's development [1] Company Summary - DCTY0801 injection targets the EGFRvIII mutation antigen and is a CAR-T cell product aimed at treating recurrent or progressive high-grade gliomas [1] - The approval of the clinical trial for DCTY0801 injection is expected to accelerate the development progress of the company's pipeline products and enhance its core competitiveness in the field of cancer treatment [1]

Core Viewpoint - The approval of the clinical trial for DCTY0801 injection marks a significant milestone in the product development process for the company, enhancing its competitiveness in the oncology treatment sector [1] Group 1 - The company's subsidiary, Beijing Dingcheng Peptide Source Biotechnology Co., Ltd., received the clinical trial approval notice from the National Medical Products Administration [1] - The drug DCTY0801 is indicated for EGFRvIII positive recurrent or progressive high-grade glioma [1] - This clinical trial approval is expected to accelerate the progress of the company's research and development products [1]

香港聯合交易所有限公司與證券及期貨事務監察委員會對本申請版本的內容概不負責，對其準確性或完整 性亦不發表任何意見，並明確表示概不就因本申請版本全部或任何部分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。 Betta Pharmaceuticals Co., Ltd. 貝達藥業股份有限公司 （於中華人民共和國註冊成立的股份有限公司） 的申請版本 警告 本申請版本乃根據香港聯合交易所有限公司（「聯交所」）及證券及期貨事務監察委員會（「證監會」）的要求 而刊發，僅用作提供資料予香港公眾人士。 本申請版本為草擬本，其內所載資料並不完整，亦可能會作出重大變動。 閣下閱覽本文件，即代表 閣 下知悉、接納並向貝達藥業股份有限公司（「本公司」）、其聯席保薦人、整體協調人、顧問或包銷團成員 表示同意： 本公司文件根據香港法例第32章公司（清盤及雜項條文）條例送呈香港公司註冊處處長登記前，本公司不 會向香港公眾人士提出要約或邀請。倘於適當時候向香港公眾人士提出要約或邀請，有意投資者務請僅依 據呈交香港公司註冊處註冊的本公司文件作出投資決定；有關文本將於發售期內向公眾刊發。 (a) 本文件僅為向香港公眾人士提供有關本公 ...

Core Insights - Gilead Sciences, Inc. (GILD) has demonstrated strong performance in 2025, with shares rising 26.5% year to date, significantly outperforming the industry growth of 6% [1][9] - The FDA approval of lenacapavir, branded as Yeztugo, for HIV prevention has been a pivotal event, marking it as the first twice-yearly injectable pre-exposure prophylaxis (PrEP) option in the U.S. [3][7] Gilead's HIV Portfolio - Gilead holds a leading position in the HIV treatment market, with its flagship drug Biktarvy commanding over 51% market share in the U.S. [4] - The company anticipates a 3% growth in HIV sales for 2025, up from previous expectations of flat revenue, driven by strong performances from Biktarvy and Descovy [5] - The approval of Yeztugo enhances Gilead's HIV portfolio, especially as Truvada faces generic competition [6] Oncology and Cell Therapy - Gilead's oncology portfolio includes Trodelvy, which has shown strong performance in treating metastatic triple-negative breast cancer, with plans for further approvals [11] - However, the Cell Therapy franchise, including Yescarta and Tecartus, is facing competitive pressures in the U.S. and Europe [12] - Gilead's subsidiary Kite has acquired Interius BioTherapeutics for $350 million, enhancing its capabilities in CAR T-cell therapies [13] Liver Disease Portfolio - The FDA approval of seladelpar, branded as Livdelzi, for primary biliary cholangitis (PBC) has strengthened Gilead's liver disease portfolio [14][15] Financial Performance and Estimates - Gilead's shares are currently trading at a price/earnings ratio of 13.62x forward earnings, lower than the large-cap pharma industry's average of 14.83x [16] - Earnings estimates for 2025 have increased to $8.10 from $8.02, while the estimate for 2026 has slightly decreased to $8.50 from $8.53 [17] Strategic Collaborations - Gilead has partnered with the U.S. State Department to deliver lenacapavir, indicating a commitment to expanding its HIV prevention efforts [10] - The company is also collaborating with Merck to evaluate a combination treatment for HIV, with updates expected in 2026 [20] Dividend and Cash Position - Gilead has maintained a strong cash position, with $7.1 billion in cash and equivalents as of June 30, 2025, supporting its sustainable dividend yield of 2.76% [22] - In Q2 2025, Gilead paid out $994 million in dividends and repurchased $527 million of common stock, reflecting its commitment to returning value to shareholders [21]

Core Insights - The 28th Annual Academic Conference of the Chinese Society of Clinical Oncology (CSCO) showcased significant research findings on innovative cancer treatments, particularly focusing on the efficacy and safety of Anlotinib in various cancer types [1][2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22]. Non-Small Cell Lung Cancer (NSCLC) - Anlotinib combined with immune checkpoint inhibitors (ICIs) shows potential as an adjuvant therapy for non-pathological complete response (non-pCR) NSCLC patients post-neoadjuvant immunotherapy, with manageable safety profiles and promising disease-free survival [1]. - A prospective study indicates that the combination of Tislelizumab, Anlotinib, and chemotherapy is effective for resectable NSCLC, achieving a major pathological response (MPR) rate of 81.3% [2]. - Anlotinib combined with Pembrolizumab demonstrates efficacy in elderly patients with advanced PD-L1 positive NSCLC, with a median progression-free survival (PFS) of 8.2 months [3][4]. - The combination of Anlotinib, Pembrolizumab, and chemotherapy shows promising results in treating pulmonary sarcomatoid carcinoma, with an overall response rate (ORR) of 80% [5]. - Real-world data suggests that Anlotinib combined with PD-1/PD-L1 inhibitors is effective for advanced NSCLC, with a median PFS of 7.8 months and an overall survival (OS) of 17.0 months [6]. - A retrospective analysis indicates that Anlotinib combined with ICIs is a viable option for advanced NSCLC patients who have progressed after prior immunotherapy, showing an ORR of 28.6% [8]. Small Cell Lung Cancer (SCLC) - A study on the combination of liposomal Irinotecan, platinum-based chemotherapy, and Anlotinib for extensive-stage SCLC shows promising results, with a focus on maintaining treatment efficacy post-induction therapy [9]. - The combination of Surufatinib, albumin-bound Paclitaxel, and Anlotinib in second-line treatment for extensive-stage SCLC demonstrates a high ORR of 73.33% [10]. - Anlotinib combined with ICIs shows improved efficacy compared to Anlotinib alone in treating extensive-stage SCLC, with a median PFS of 6.5 months [11]. Gastrointestinal Tumors - Anlotinib combined with TAS-102 shows potential as a third-line treatment for metastatic colorectal cancer, with a DCR of 95% and a median PFS of 5.6 months [12]. - The combination of Anlotinib and chemoradiotherapy demonstrates significant efficacy in treating postoperative lymph node recurrence of esophageal squamous cell carcinoma, with a median PFS of 20.2 months [13]. Soft Tissue Sarcoma - Anlotinib combined with Cadonilimab shows promising results in advanced soft tissue sarcoma patients who have failed first-line treatment, with a median PFS of 6.9 months [14]. - The combination of Atezolizumab and Anlotinib in treating advanced liposarcoma and leiomyosarcoma shows a DCR of 89.5% [15]. Thyroid Cancer - Anlotinib combined with Sintilimab shows efficacy in treating BRAF wild-type anaplastic thyroid cancer, with an ORR of 47.6% and a median PFS of 9.63 months [17][18]. Other Cancers - The combination of Sintilimab and Anlotinib shows efficacy in treating advanced SMARCA4-deficient thoracic tumors, with an ORR of 51% [19]. - A real-world study indicates that prior treatment with Bevacizumab does not affect the efficacy of Anlotinib in treating solid tumors, with significant benefits observed in combination therapies [20]. Neutropenia Prevention - The Guard-04 study demonstrates that Aibegersit can effectively prevent chemotherapy-induced neutropenia in colorectal and pancreatic cancer patients, with manageable safety profiles [22].

Group 1 - The core viewpoint of the article highlights the successful IPO of Jinfang Pharmaceutical-B (02595), with shares priced at HKD 20.39 and a total issuance of 89.24 million shares, raising approximately HKD 1.6699 billion in net proceeds [1] - As of the report, the stock price surged by 128.05%, reaching HKD 46.50, with a trading volume of HKD 651 million [1] - Jinfang Pharmaceutical focuses on developing new treatment solutions for oncology, autoimmune, and inflammatory diseases, with a product pipeline that includes eight candidate products, five of which are in clinical development [1] Group 2 - The company’s core products include GFH925, the first KRAS G12C inhibitor approved in China and the third globally, which received approval from the National Medical Products Administration for non-small cell lung cancer (NSCLC) in August 2024 [1] - GFH375 is an oral KRAS G12D inhibitor currently undergoing Phase II clinical trials in China [1] - Jinfang Pharmaceutical has entered into a licensing agreement with Verastem for three candidate products, including GFH375, granting Verastem development and commercialization rights outside Greater China [1]

Core Viewpoint - Jinfang Pharmaceutical-B (2595.HK) debuted on the Hong Kong Stock Exchange today, opening 115.79% higher at HKD 44, with a market capitalization of HKD 15.2 billion [1] Company Overview - Jinfang Pharmaceutical was established in 2017, focusing on developing new treatment solutions for oncology (covering various solid tumors) as well as autoimmune and inflammatory diseases [1] Financial Performance - In the first four months of 2023, 2024, and 2025, the company reported revenues of CNY 74 million, CNY 105 million, and CNY 82 million respectively [1] - Research and development expenditures for the same periods were CNY 313 million, CNY 332 million, and CNY 69.8 million respectively [1] - The net losses for these periods were CNY 508 million, CNY 678 million, and CNY 66 million, totaling over CNY 1.2 billion in losses over two years [1] Product Development - Jinfang Pharmaceutical currently has one core product, GFH925 (brand name: Daberut), which has been approved for market launch [1] - The commercialization of GFH925 in the domestic market relies on partnerships, and in January 2024, the company terminated the overseas option under the licensing agreement with Innovent Biologics, requiring a refund of USD 20 million [1]

Group 1 - The core viewpoint of the article highlights the successful listing of Jinfang Pharmaceutical-B (02595) with a share price of HKD 20.39, raising approximately HKD 1.6699 billion from the issuance of 89.24 million shares [1] - As of the report, the stock surged by 115.79%, trading at HKD 44 with a transaction volume of HKD 491 million [1] - Jinfang Pharmaceutical focuses on developing new treatment solutions for tumors, autoimmune, and inflammatory diseases, with a product pipeline that includes 8 candidate products, 5 of which are in clinical development [1] Group 2 - GFH925, one of the core products, is the first KRAS G12C inhibitor approved in China and the third globally, having received approval from the National Medical Products Administration for non-small cell lung cancer (NSCLC) in August 2024 [1] - The company is conducting a Phase II trial of GFH925 in the EU under the KORCUS study [1] - GFH375, an oral KRAS G12D inhibitor, is currently undergoing Phase II clinical trials in China, and the company has entered into a licensing agreement with Verastem for GFH375 and two other candidate products, granting Verastem development and commercialization rights outside Greater China [1]

Core Insights - The company, Jinfang Pharmaceutical-B (02595), conducted an IPO from September 11 to 16, raising significant interest with a subscription amount of HKD 349.85 billion, resulting in an oversubscription rate of 2,210 times for the public offering portion [1] - The company plans to issue 77.6 million H-shares at a price of HKD 20.39 per share, aiming to raise HKD 1.58 billion, with the shares expected to be listed in Hong Kong on September 19 [1] - Jinfang Pharmaceutical focuses on developing new treatment solutions for oncology, autoimmune, and inflammatory diseases, with a product pipeline that includes eight candidate products, five of which are in clinical development [1][2] Financial Details - The net proceeds from the IPO will be allocated as follows: approximately 33% for the clinical development of core product GFH925, about 38% for core product GFH375, around 19% for the development of other candidates in the pipeline, and about 10% for working capital and general corporate purposes [2] Product Pipeline - Core product GFH925 (fulzerasib, marketed as Daberet®) has been commercially approved in China for the treatment of advanced non-small cell lung cancer (NSCLC) and is currently undergoing Phase II trials in the EU [1] - Another core product, GFH375, is an oral small molecule inhibitor targeting KRAS G12D mutations, with ongoing Phase I/II clinical trials in China for patients with advanced solid tumors carrying this mutation [2]

Core Viewpoint - The company, Jinfang Pharmaceutical-B, is planning a global offering of 77.6 million H-shares, with a proposed price of HKD 20.39 per share, aiming to raise approximately HKD 1.4436 billion for further development of its core products and other candidates [1][2]. Group 1: Offering Details - The company intends to offer 77.6 million H-shares, with 7.76 million shares available in Hong Kong and 69.84 million shares for international investors [1]. - The subscription period for the shares is set from September 11 to September 16, 2025, with trading expected to commence on September 19, 2025 [1]. - The company has appointed CITIC Securities as the sole sponsor for the offering [1]. Group 2: Use of Proceeds - Approximately 71% of the net proceeds from the global offering will be allocated to the further development of core products GFH925 and GFH375 [2]. - About 19% of the net proceeds will be used for the development of other candidate products, including GFH312, GFS202A, GFH276, GFS784, and other preclinical candidates [2]. - The remaining 10% of the net proceeds will be utilized for operational expenses and other general corporate purposes [2]. Group 3: Cornerstone Investment - The company has entered into cornerstone investment agreements, with investors agreeing to subscribe for shares totaling USD 100 million (approximately HKD 780 million) under certain conditions [2]. - The cornerstone investors include notable entities such as RTW Fund, TruMed, OrbiMed, UBS Asset Management (Singapore) Ltd., Vivo Fund, and others [2]. - Assuming the offering price of HKD 20.39 per share, cornerstone investors are expected to purchase a total of 38.234 million shares [2].