Core Insights - Company announced the latest progress of the CS1003-305 study, a Phase III clinical trial evaluating the efficacy and safety of PD-1 monoclonal antibody nofazinlimab in combination with lenvatinib for patients with unresectable or metastatic hepatocellular carcinoma (HCC) [1] - The study involved 74 research centers globally and aimed to compare the combination therapy against placebo plus lenvatinib, with overall survival (OS) as the primary endpoint [1] - Final analysis indicated a clear clinical benefit trend for the combination therapy, although it did not reach statistical significance, showing tangible patient benefits [1] - The combination therapy also demonstrated clinically meaningful improvements in progression-free survival (PFS) and objective response rate (ORR), comparable to current standard treatments [1] - Nofazinlimab exhibited good safety profile consistent with previous studies and existing PD-(L)1 antibodies, with no new safety signals observed [1] - The company plans to communicate with regulatory authorities to seek a registration pathway for the combination therapy [1] Product Information - Nofazinlimab is a humanized recombinant IgG4 monoclonal antibody targeting programmed cell death protein 1 (PD-1), developed for tumor immunotherapy [2] - It has high affinity for PD-1 in humans, crab-eating macaques, and mice, blocking the interaction between PD-1 and its ligands PD-L1 and PD-L2 [2] - Nofazinlimab received Orphan Drug Designation (ODD) from the FDA in July 2020 for the treatment of hepatocellular carcinoma [2]

Group 1: Market Overview - The Hang Seng Index fell by 0.96%, down 232 points, closing at 23,989 points, while the Hang Seng Tech Index decreased by 1.20% [1] - The Hong Kong stock market saw a trading volume of HKD 130.6 billion in the morning session [1] Group 2: Pharmaceutical Sector - The National Healthcare Security Administration and the National Health Commission released measures to support the high-quality development of innovative drugs, indicating that innovative drugs remain a key investment theme [1] - The Hang Seng Biotechnology Index surged by 2.79% [1] - Ascentage Pharma-B (06855) rose by 8%, Kelun-Biotech (06990) increased by 7%, and Zai Lab (09688) gained 5.21% [1] - Kangfang Biotech (09926) saw a rise of over 11% as its first dual-antibody ADC drug AK146D1 entered clinical enrollment [2] - Innovent Biologics (01801) increased by over 6% following the approval of its drug Ma Shidu Peptide for commercialization [3] - CStone Pharmaceuticals-B (02616) rose by over 11% after disclosing two dual-specific antibody drug targets, CS2013 and CS2015 [4] - Sihuan Pharmaceutical (02096) gained 4.43% after its new generation anti-VEGF monoclonal antibody "Suvetizumab" was approved for market [5] Group 3: Other Sectors - Gaming stocks continued to rise, with Macau's June gaming revenue exceeding expectations, and Citigroup predicts growth momentum will continue in the second half of the year [5] - MGM China (02282) increased by 2.6%, and Melco International Development (00200) rose by 1.75% [5] - Wheelock Properties (01997) gained 7.32% as Hong Kong's retail sales value rebounded in May, leading Morgan Stanley to upgrade the company's rating [5] - Global New Material International (06616) rose by over 5% as the acquisition of Merck's surface solutions business is nearing completion [6] - Giant Star Legend (06683) increased by over 3% after its subsidiary invested USD 8 million in the Starlight New Economy Industry Fund [7] - Kingsoft (03888) fell nearly 7% as its new game "Unrestricted Machine" entered public testing, with market attention on its performance [8]

Core Insights - Company disclosed two proprietary bispecific antibody drug candidates targeting autoimmune/inflammatory diseases: CS2013 and CS2015, both showing potential as best-in-class or first-in-class therapies [1][2] - CS2013 targets BAFF and APRIL to block B cell and plasma cell development, with preclinical data indicating a synergistic effect and superior pharmacokinetic properties compared to fusion protein drugs [1] - CS2015 targets OX40L and TSLP, providing a new treatment strategy for type 2 inflammatory diseases such as atopic dermatitis and asthma, also showing long half-life and potential for subcutaneous administration [2] Company Strategy - The CEO emphasized the significant unmet needs in the autoimmune/inflammatory disease market, which is becoming the second-largest disease market after oncology, due to the variety of diseases and large patient base requiring lifelong treatment [2] - The development of CS2013 and CS2015 reflects the company's strategic expansion beyond oncology and its commitment to innovation aimed at improving global patient health [2] - The company plans to initiate IND preparation for new drug clinical trials in the second half of 2025 [1]

Group 1 - Key Point 1: 基石药业-B (02616) rose over 5% after its drug for lung cancer,舒格利单抗, received long-term survival data recognition in The Lancet Oncology, reinforcing its position as a first-line treatment in Europe [2] - Key Point 2: 海昌海洋公园 (02255) increased by over 4% as a major shareholder, 祥源控股, is set to acquire a 38.6% stake for HKD 22.95 billion, potentially alleviating liquidity pressures [2] - Key Point 3: 冠忠巴士 (00306) surged 27% with a projected 143% increase in annual pre-tax profit to HKD 165 million, driven by revenue growth, reduced fuel costs, and autonomous driving licenses [2] Group 2 - Key Point 1: 东方表行 (00398) fell over 5% due to a 5.2% decline in revenue and a 20% drop in net profit, attributed to weak luxury goods demand amid geopolitical conflicts and interest rate fluctuations [2] - Key Point 2: 北森控股 (09669) plummeted over 17% as its adjusted annual EBITDA was only HKD 28.9 million, with Everbright Securities lowering revenue forecasts by 10%-15% due to growth challenges [3] - Key Point 3: 顺丰控股 (06936) rose over 6% to a new high, with May express delivery revenue increasing by 13.4%, and the scaling of unmanned delivery vehicles potentially opening up future profit opportunities [3] Group 3 - Key Point 1: 中国中免 (01880) increased by over 5% as it accelerates the expansion of its duty-free stores, with 4 already opened and 9 more in preparation, benefiting from favorable policies [3] - Key Point 2: 华虹半导体 (01347) rose over 7% with a capacity utilization rate of 102.7%, and Tianfeng Securities optimistic about future contributions of USD 1.28 billion from its 9th factory [3] - Key Point 3: 网龙 (00777) increased over 3% after showcasing AI digital human presentation technology at a UN conference, launching the "EDA Education Metaverse" strategy, which catalyzed a revaluation of AI [4]

Group 1 - As of June 3, a total of 105 stocks reached their 52-week highs, with Huayin International Holdings (00989), Dingyifeng Holdings (00612), and Youquhui Holdings (02177) leading the high rate at 57.26%, 37.93%, and 23.02% respectively [1] - The closing prices and highest prices for the top three stocks are as follows: Huayin International Holdings at 1.370 and 1.950, Dingyifeng Holdings at 0.770 and 0.800, and Youquhui Holdings at 3.550 and 3.580 [1] - Other notable stocks that reached their 52-week highs include China Antibody-B (03681) with a high rate of 21.62% and Fengcheng Holdings (02295) at 19.52% [1] Group 2 - The report also lists stocks that reached their 52-week lows, with Des Holdings (08437) showing the largest decline at -38.79%, followed by Dimi Life Holdings (01667) at -20.50% [3] - The closing prices and lowest prices for the top three stocks that reached their lows are: Des Holdings at 0.177 and 0.071, Dimi Life Holdings at 0.140 and 0.128, and Lujizhi Technology (01745) at 0.197 and 0.194 [3] - Other stocks with significant declines include GBA Group (00261) at -11.48% and Baide International (02668) at -10.88% [3]

Group 1 - The Hong Kong pharmaceutical stocks are experiencing a strong performance, with notable gains in several companies [1] - Yiming Anke-B (01541.HK) has increased by 8.38%, while Cornerstone Pharmaceuticals-B (02616.HK) has risen by 7.82% [1] - Other companies such as Baijie Shenzhou (06160.HK), Jakes-B (01167.HK), and Ying'en Biotechnology-B (09606.HK) have also shown positive movements, with increases of 3.25%, 2.80%, and 2.68% respectively [1]

Core Viewpoint - The pharmaceutical market, particularly innovative drug companies, is experiencing significant growth, with substantial support from policies, leading to the emergence of high-performing stocks similar to Changchun Gaoxin. Group 1: Market Performance - The Hong Kong innovative drug index has increased from 859 points at the beginning of the year to 1284 points, representing a 50% rise [1] - The mainland innovative drug index has risen from a low of 948 to a high of 1156, showing a 22% increase, indicating a significant lag compared to Hong Kong [1] Group 2: Stock Performance - Several stocks in the Hong Kong innovative drug sector have seen substantial gains, such as: - Kintor Pharmaceutical rising from 2.48 to 19.78 HKD - Akeso increasing from 1.2 to 4.3 HKD - CanSino Biologics moving from 2 to 8.73 HKD - CStone Pharmaceuticals growing from 0.8 to 3.89 HKD - Innovent Biologics increasing from 26.45 to 105.5 HKD [4] - The current bullish trend in Hong Kong's innovative drug sector is viewed as just the beginning, with expectations of a long-term market cycle lasting 50 years [4] Group 3: Historical Comparisons - Historical data from 2005 to 2007 shows that Hong Kong real estate stocks typically initiated their upward trends over six months before A-share stocks, with A-share stocks generally experiencing greater increases [5] - Examples include: - China Overseas Land rising from 2.29 to 21.95 HKD - Vanke increasing from 6.76 to 33.82 HKD - Deep Zhenye rising from 19.90 to 271.8 HKD [5] - The patterns observed in the real estate sector may provide insights into the potential trajectory of mainland innovative drug stocks, suggesting a possible follow-up to the Hong Kong market's performance [5]

Core Viewpoint - The company, Basestone Pharmaceuticals, has announced significant advancements in its clinical pipeline, particularly focusing on the dual-targeting antibody CS2011, which shows promise in treating various cancers by effectively blocking key signaling pathways associated with tumor growth [1][22]. Group 1: CS2011 Development - CS2011 is a dual-specific antibody targeting EGFR and HER3, capable of blocking nearly all HER family-related signaling pathways except for HER2 homodimers, thus overcoming tumor heterogeneity [2][5]. - The binding affinity of CS2011 to EGFR is 2.04 nM and to HER3 is 5.04 nM, with a combined affinity of less than 1 pM for both targets [8]. - CS2011 effectively binds to tumor cells expressing either EGFR or HER3 alone, as well as those expressing both [9]. Group 2: Comparative Efficacy - In both in vitro and in vivo studies, CS2011 demonstrated superior anti-tumor activity compared to potential major competitors, including EGFR monoclonal antibodies and HER3 monoclonal antibodies [11][12]. - CS2011's ability to inhibit downstream EGFR signaling is comparable to that of EGFR monoclonal antibodies, while its inhibition of HER3 signaling surpasses that of competing dual-target antibodies [12][14]. - In animal models, CS2011 exhibited tumor suppression effects superior to those of EGFR and HER3 monoclonal antibodies, with efficacy comparable to combination therapies involving both [16]. Group 3: Other Pipeline Products - CS5007, an ADC targeting EGFR and HER3, is designed using the CS2011 antibody framework, aiming to be a leading candidate in precision oncology [21]. - CS5005 is a first-in-class ADC targeting SSTR2, showing strong anti-tumor activity in preclinical studies and good tolerability in initial toxicity studies [22]. - CS5006 is another first-in-class ADC targeting ITGB4, which has shown significant upregulation in various cancers while maintaining low expression in normal tissues, indicating its therapeutic potential [23].

Core Insights - Company announced the presentation of preclinical research results for its key product CS2009 at the 2025 AACR annual meeting, focusing on a tri-specific antibody targeting PD-1, VEGFA, and CTLA-4 [1] - CS2009 is currently undergoing a global multi-center Phase I clinical trial in Australia, with the first patient dosed in March 2023, and plans to expand to China and the United States [1] - The tri-specific mechanism of CS2009 aims to enhance anti-tumor effects by integrating three validated targets, potentially surpassing existing therapies based on PD-(L)1 [1][2] Group 1 - CS2009 targets PD-1, VEGFA, and CTLA-4, showing promise in the treatment of solid tumors and the potential to replace current PD-(L)1-based therapies [2] - The combination of PD-1 and CTLA-4 blockade has demonstrated synergistic effects in various tumor types, significantly improving overall survival (OS) and progression-free survival (PFS) [1] - Further blocking of the VEGFA signaling pathway is expected to enhance the therapeutic efficacy of CS2009 [1]

Financial Performance - Total revenue for the year ended December 31, 2024, was RMB 407.2 million, a decrease of RMB 56.6 million or 12.2% year-over-year[11]. - Revenue from licensing fees increased by RMB 108.3 million or 113.1% year-over-year, significantly offsetting the decline in drug sales revenue[11]. - R&D expenses decreased from RMB 527.8 million in 2023 to RMB 134.7 million in 2024, a reduction of RMB 393.1 million[11]. - Administrative expenses decreased from RMB 182.7 million in 2023 to RMB 77.8 million in 2024, a reduction of RMB 104.9 million[11]. - Sales and marketing expenses decreased from RMB 199.3 million in 2023 to RMB 133.8 million in 2024, a reduction of RMB 65.5 million[11]. - Net loss for the year decreased by RMB 276.0 million or 75.2% to RMB 91.2 million in 2024, primarily due to a significant reduction in operating expenses[11]. - Cash and cash equivalents and time deposits as of December 31, 2024, amounted to RMB 672.9 million[11]. - Total assets as of December 31, 2024, were RMB 1,393.5 million, down from RMB 1,661.0 million in 2023[12]. - Total liabilities as of December 31, 2024, were RMB 1,029.6 million, compared to RMB 1,205.2 million in 2023[12]. Drug Development and Regulatory Approvals - The company achieved significant milestones in regulatory approvals, clinical progress, and strategic partnerships, reinforcing its leadership in innovative therapies[13]. - Three new drug applications (NDA) are expected to be approved in 2024, including a fifth indication for the drug Zhejie Mei® in China for first-line treatment of gastric/gastroesophageal junction adenocarcinoma (GC/GEJC)[14]. - Shugli monoclonal antibody has been approved in the EU and the UK for first-line treatment of stage IV non-small cell lung cancer (NSCLC), marking its entry into major international markets[14]. - The drug Taji Hua® (Avapritinib) has been included in the National Reimbursement Drug List (NRDL) in China, effective January 1, 2024, improving affordability for eligible patients[18]. - CS5001 (ROR1 ADC) has shown promising clinical data, with an objective response rate (ORR) of 70% for non-Hodgkin lymphoma (NHL) and 100% for Hodgkin lymphoma (HL) at the recommended phase II dose[24]. - The GEMSTONE-304 study results for first-line esophageal squamous cell carcinoma (ESCC) are expected to be published in Nature Medicine in February 2024[16]. - CS5001 (ROR1 ADC) and CS2009 (PD-1/VEGF/CTLA-4 tri-specific antibody) are advancing to critical trials, with plans to seek global partnerships to accelerate development[29]. Strategic Partnerships and Collaborations - The company has established strategic alliances to enhance global commercialization, including partnerships with Ewopharma AG and Pharmalink Store for market access in Central and Eastern Europe, MENA, and Latin America[16]. - A strategic commercialization partnership was established with Ewopharma, granting them commercialization rights for Sugli monoclonal antibody in Switzerland and 18 Central and Eastern European countries, with potential upfront payments of up to $51.3 million[43]. - The company has entered a commercialization strategic partnership with Pharmalink for Sugliant (舒格利单抗) in the Middle East, North Africa, and South Africa, receiving upfront and milestone payments based on net sales[45]. - The company plans to establish more partnerships in Western Europe, Southeast Asia, and Canada by 2025[16]. Clinical Trials and Pipeline Development - The company is advancing its pipeline with over nine potential candidates in preclinical stages, focusing on first-in-class and best-in-class characteristics across various therapeutic areas[27]. - A global Phase I trial for CS2009 (PD-1/VEGF/CTLA-4 tri-antibody) has been initiated in Australia, with plans to expand to China and the US[25]. - CS5001 is currently ranked among the top two candidates globally in clinical progress, showing promising Ia phase data for aggressive and indolent lymphomas[33]. - The company’s product pipeline has made significant progress, with CS5001 (ROR1 ADC) entering phase 1b, showing promising efficacy and safety in clinical trials[49]. Management and Governance - The board of directors includes a mix of executive and independent non-executive members, with some set to retire at the upcoming annual general meeting[129]. - The company has received annual independence confirmations from all independent non-executive directors, affirming their independence during the reporting period[132]. - The compensation committee has been established according to Listing Rule 3.25 and Appendix C1 of the Corporate Governance Code to determine the remuneration policy for directors and senior management[134]. - The leadership team has a strong background in business development and strategic management, which is expected to drive future growth and market expansion[110][116]. Stock Options and Incentive Plans - The company has adopted three share incentive plans[153]. - The total number of stock options granted is 73,147,494, with 17,482,900 options currently unexercised and 8,083,239 options exercised[164]. - The stock options program is designed to incentivize long-term performance and retention of key personnel[167]. - The company aims to align employee incentives with long-term performance through its stock option and restricted share unit plans[175]. Market Presence and Future Outlook - The company aims to maximize the global commercial potential of its approved drugs through strategic collaborations and localized production[28]. - The company is focused on expanding its market presence and developing new products, as evidenced by ongoing clinical trials and strategic partnerships[51]. - The company aims to enhance the accessibility and affordability of Tai Ji Hua® (Apatinib) through its inclusion in the national insurance list[50]. - The company is committed to maintaining its competitive edge in the market through innovative product development and strategic collaborations[40].