Core Insights - The Shanghai Stock Exchange Sci-Tech Innovation Board Biopharmaceutical Index has shown a positive trend, with notable increases in constituent stocks such as Zhenhua Cell and Rongchang Biopharmaceutical [1][3] - The Jiashi Sci-Tech Medicine ETF has experienced significant trading activity and growth, leading in both scale and share increase among comparable funds [3][6] Market Performance - As of June 24, 2025, the Sci-Tech Innovation Board Biopharmaceutical Index rose by 0.82%, with Zhenhua Cell up by 9.46% and Rongchang Biopharmaceutical up by 4.23% [1] - The Jiashi Sci-Tech Medicine ETF recorded a turnover of 8.8% and a transaction volume of 18.05 million yuan, with an average daily transaction of 41.47 million yuan over the past month [3] Fund Growth - The Jiashi Sci-Tech Medicine ETF has seen a scale increase of 128 million yuan over the past year, leading among comparable funds [3] - The fund's net asset value has increased by 21.01% over the past year, with a historical one-year profit probability of 72.17% [3][6] Top Holdings - The top ten weighted stocks in the Sci-Tech Innovation Board Biopharmaceutical Index account for 51.6% of the index, with leading companies including United Imaging Healthcare and BeiGene [3][5] Industry Trends - Recent significant licensing deals in the Chinese innovative pharmaceutical sector include a $6 billion deal by 3SBio and a $5.33 billion strategic collaboration between CSPC and AstraZeneca [5][6] - Chinese innovative pharmaceutical companies are demonstrating competitive advantages in R&D efficiency and cost control, particularly in advanced technology fields such as ADC and cell therapy [6]

Summary of Key Points from the Conference Call Industry Overview - The conference highlighted the significant advancements in China's innovative drug development, particularly in the oncology sector, showcased at the ASCO conference with a record number of presentations and reports [2][1]. Core Insights and Arguments - **Increased Global Competitiveness**: Chinese innovative drugs have shown remarkable improvement in global competitiveness, evidenced by a rise in high-value licensing agreements and a record number of presentations at ASCO, including 73 oral presentations and 11 LBA reports [2][1]. - **Significant Data from IBI363**: - IBI363, a second-generation IO product from Innovent Biologics, demonstrated a total survival rate (OS) exceeding 15 months in non-small cell lung cancer (NSCLC) patients, significantly outperforming existing therapies [6][10]. - In colorectal cancer, the 1 mg dose group achieved an OS of 17.5 months, nearing first-line treatment levels, with a disease control rate (DCR) exceeding 60% when combined with Bevacizumab [7][8]. - **Advancements in Dual Antibodies**: Companies like Innovent, Zai Lab, and 3SBio reported promising data in the dual antibody sector, particularly with IBI363 enhancing IL-2 functionality while reducing toxicity [3][1]. - **ADC and Small Molecule Innovations**: Companies such as Hengrui, Kelun, and Innovent showcased strong data in the ADC and small molecule therapy fields, indicating ongoing innovation in these advanced treatment modalities [5][1]. Noteworthy Developments - **Kangfang Biotech's Progress**: The PD-1 antibody, Cadonilimab, showed promising progression-free survival (PFS) rates of 12 months in patients with low PD-L1 expression, highlighting its potential in cervical cancer treatment [14][1]. - **Botai's ADC Drug Performance**: Botai's ADC drug 264 exhibited an overall response rate (ORR) of 45.1% in HER2 mutation-resistant patients, significantly higher than the control group [26][1]. - **Clinical Data from Other Companies**: - Companies like BeiGene and Maiwei Biotech presented data on ADCs and small molecules, demonstrating significant advancements in the treatment of various malignancies [16][1][17][1]. - The combination of Savolitinib and Osimertinib in NSCLC patients showed a PFS of 8.2 months, indicating a substantial improvement over chemotherapy [23][24]. Additional Important Insights - **Safety and Efficacy of IBI363**: Despite a treatment-related adverse event (TRAE) rate exceeding 40%, the main side effects were manageable, and the overall safety profile was deemed controllable [10][1]. - **Future Expectations for IBI363**: There is optimism regarding IBI363's future clinical data in first-line treatments and its safety profile in various indications, enhancing market confidence [9][1]. - **Emerging ADC Data**: Companies like LianTuo Biotech reported promising ADC data, with B7H3 ADC showing an ORR of 42.3% in CRPC patients [28][1]. This summary encapsulates the key points discussed during the conference call, focusing on the advancements in the Chinese pharmaceutical industry, particularly in oncology, and the promising data from various innovative therapies.

Core Insights - The focus of the pharmaceutical market at this year's ASCO was on two PD-1/VEGF bispecific antibody deals and the data readout of the PD-1/VEGF antibody from CanSino/Summit [1] - Merck (MSD) is actively adjusting its oncology pipeline and R&D strategy, emphasizing PD-1/VEGF bispecific antibodies and antibody-drug conjugates (ADCs) to address challenges from the impending patent expiration of its key product, Keytruda [1] - The company anticipates that its late-stage oncology pipeline could generate over $25 billion in commercial opportunities by the mid-2030s, with ADCs expected to contribute more than half of this revenue [1] PD-1/VEGF Bispecific Antibodies - Merck believes the biological mechanism of PD-1 and VEGF combination therapy has been validated, showing improvements in progression-free survival (PFS) across various indications [2] - The management noted that while there are clinically meaningful overall survival (OS) data, the statistical significance of OS benefits remains an "open question" [2] - Merck has secured global exclusive rights to the PD-1/VEGF bispecific antibody LM-299 (internal code MK-2010) through a partnership with LaNova Medicines, currently undergoing I/II clinical trials in China [2] - The choice to conduct early research in China is aimed at leveraging local clinical research infrastructure and collaborating with local partners for faster development [2] - The future success of MK-2010 hinges on demonstrating clear clinical benefits based on mature OS data [2] ADC Development - Merck views ADCs as a crucial component of its future oncology pipeline, claiming to be advancing "one of the industry's broadest ADC projects" [3] - The ADC Sacituzumab Tirumotecan (sac-TMT) is a core project developed in collaboration with Kura Oncology, showing potential in early clinical studies in China, particularly for EGFR-mutant NSCLC and triple-negative breast cancer (TNBC) patients [3] - Sac-TMT has been approved in China for treating TNBC and locally advanced or metastatic EGFR-mutant NSCLC, marking it as the first TROP2 ADC approved for lung cancer in China [3] - The FDA has granted breakthrough therapy designation for Sac-TMT for specific treated advanced or metastatic non-squamous NSCLC with EGFR mutations in the U.S. [3] - Merck's executives described Sac-TMT as a "just right" workhorse ADC during the ASCO 2025 investor event [3] Differentiation Strategy - The differentiation strategy for Sac-TMT includes a biweekly dosing regimen, manageable toxicity profiles, and development plans exploring its use in maintenance therapy [4] - Merck has planned 14 registrational studies for Sac-TMT, with several having the potential to become first-in-class [4] - Competitors in the TROP2 ADC space include Gilead's Trodelvy and AstraZeneca/Daiichi Sankyo's Datopotamab deruxtecan (Dato-DXd) [4] Future Oncology Plans and BD&MA - Merck's oncology development leverages the experience gained from Keytruda, categorizing its pipeline into three main types: immune-oncology drugs, precision-targeted drugs, and ADCs [5] - The company aims to address tumor types with suboptimal PD-(L)1 inhibition effects, such as small cell lung cancer, colorectal cancer, and hematological malignancies [5] - The combination of Keytruda with the KRAS G12C inhibitor MK-1084 has entered Phase III clinical trials [5] - In terms of business development and mergers & acquisitions (BD&MA), Merck's criteria focus on whether the target asset demonstrates an unambiguous promotable advantage and whether Merck can significantly drive market growth [5]

Core Viewpoint - The article highlights the performance of various sectors in the stock market, particularly focusing on the pharmaceutical and automotive industries, indicating potential investment opportunities and market trends [2][7][10]. Market Overview - As of May 23, the A-share market showed slight gains, with the Shanghai Composite Index up by 0.08%, the Shenzhen Component Index up by 0.44%, and the ChiNext Index up by 0.37% [1]. - The Hong Kong stock market also experienced an upward trend, with the Hang Seng Index rising by 0.44% [5]. Sector Performance - The pharmaceutical sector demonstrated strong performance, with notable stocks like Multi-Rich Pharmaceutical and Hai Chen Pharmaceutical hitting the daily limit up [3][7]. - The automotive sector saw a rally, with companies like BYD reaching historical highs and other manufacturers like Xuelong Group and Jianghuai Automobile also experiencing gains [10][11]. Key Stock Movements - Heng Rui Pharmaceutical's stock surged over 30% on its first day of trading in Hong Kong, achieving a market capitalization of approximately HKD 396 billion [7]. - The global offering of Heng Rui Pharmaceutical included about 224.5 million shares, with a subscription rate of 454.85 times for the Hong Kong public offering [7]. Industry Insights - According to Xiangcai Securities, the domestic innovative drug industry is expected to reach a turning point in 2025, shifting from capital-driven growth to profit-driven growth, presenting dual opportunities for performance and valuation recovery [8]. - The automotive retail market is projected to reach approximately 1.85 million units in May, reflecting a year-on-year growth of 8.5% and a month-on-month increase of 5.4% [11].

Financial Data and Key Metrics Changes - The company is focused on oncology and has licensed programs to other companies, including a $150 million deal with Novartis for an anti-spike trispecific program [3] - The collaboration with Aranomed involves the development of up to six programs on a 50/50 basis, with the company retaining commercial rights to the first two programs [17] Business Line Data and Key Metrics Changes - The company is working on two distinct areas: radiopharmaceuticals and multispecific DARPins, with a focus on DLL3 and AML programs [3][10] - DLL3 is expected to enter clinical trials in the second half of the year, with promising data from compassionate use programs [38] Market Data and Key Metrics Changes - The radiopharmaceutical market is experiencing broader adoption, with increasing interest from doctors and patients [28] - The company is strategically positioned to leverage the growing demand for targeted radiopharmaceuticals, particularly with its unique DARPin platform [8][10] Company Strategy and Development Direction - The company aims to expand its pipeline through collaborations and innovative approaches in radiopharmaceuticals and immune cell engagers [16][60] - The focus is on developing differentiated therapies that avoid competition with existing treatments, such as targeting the proximal membrane portion of mesothelin [39] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of radiopharmaceuticals, comparing the current landscape to the early days of antibody-drug conjugates (ADCs) [27] - The company is optimistic about the durability of its treatments and the ability to drive patients to complete responses quickly [59] Other Important Information - The collaboration with Aranomed is significant due to their established capabilities in manufacturing and logistics for radiopharmaceuticals [15][22] - The company is exploring pretargeting systems and half-life modulation to enhance the efficacy and safety of its therapies [32][34] Q&A Session Summary Question: How does the company view the competitive landscape for DLL3-targeted therapies? - Management noted that while there are other DLL3-targeted therapies, they have not seen a significant decrease in DLL3 expression, indicating potential for their radiopharmaceuticals [46][47] Question: What are the expectations for the upcoming data from the CD3 switch DARPin? - The company anticipates presenting data showing improved response rates and the ability to maintain patients in complete response [58] Question: How does the company plan to balance its focus between radiopharmaceuticals and other platforms? - Management indicated that if both platforms prove successful, they will have the opportunity to choose the best path forward, inviting interest from potential partners [60]

Investment Rating - The industry investment rating is positive [1] Core Viewpoints - The report indicates that a turning point has been reached in the CXO sector, suggesting a positive outlook for investment [6][66] - The report highlights that the performance of domestic CXO companies has shown significant improvement, with major players like WuXi AppTec and Kintor Pharmaceutical demonstrating strong order growth [6][66] - The report emphasizes the recovery of revenue growth, with a year-over-year increase of 8.2% in Q1 2025 for CXO companies, indicating a positive trend in the sector [6][26] Financial Analysis - Domestic performance: The medical R&D outsourcing index increased by 0.82% from December 31, 2024, to April 30, 2025, outperforming the pharmaceutical and biotech index by 0.64 percentage points [5][13] - International performance: The report notes a divergence in performance among international CXO companies, with Lonza showing optimistic growth projections for its CDMO business, expecting nearly 20% growth in 2025 [5][18] - Profitability: The average gross margin for Q1 2025 was 30.9%, reflecting a year-over-year increase of 1.1 percentage points, with some companies like Medpace and Boteng showing significant improvements [6][31] - Operational efficiency: Inventory turnover rates have stabilized, with an average of 3.36 in 2024, indicating a positive trend in operational efficiency [6][36] Investment Strategy - The report suggests that the CXO sector is at a turning point, with strong growth potential in small and large molecule CDMO orders, as well as in clinical CRO opportunities driven by domestic innovation policies [6][66] - Recommended companies include WuXi AppTec and Kintor Pharmaceutical for clinical CRO, and WuXi Biologics and Kelun Pharmaceutical for CDMO [6][66] - The report highlights an increase in institutional holdings in CXO companies, indicating growing confidence in the sector [6][60]

Investment Rating - The report maintains an "Outperform" rating for the pharmaceutical sector [1]. Core Insights - The commercialization of nuclear medicine is accelerating, with significant growth in diagnostic nuclear drugs and the potential for domestic nuclear drugs to reach a commercialization inflection point [3][17]. - The report highlights the successful commercialization of Pluvicto and Lutathera, which are expected to generate substantial revenues, with Pluvicto projected to exceed $5 billion in peak sales [3][12]. - The report emphasizes the similarities between Radioligand Therapy (RDC) and Antibody-Drug Conjugates (ADC), suggesting that RDC could replicate the success of ADC in the market [3][22]. Summary by Sections Part 1: Overseas Nuclear Drug Rapid Growth, Domestic Commercialization Period - Overseas nuclear drugs are experiencing rapid commercialization, with Pluvicto achieving $1.392 billion in revenue in 2024, a 42% increase, and Lutathera generating $724 million, a 20% increase [3][12]. - The combined revenue from these two drugs for Novartis reached $2.116 billion, indicating the ongoing value realization of nuclear drugs [3][12]. - The report notes that the domestic nuclear drug market is set to expand significantly, with five new nuclear drugs approved since 2020, including Yttrium-90 microspheres from Yuan Da Pharmaceutical, which is expected to generate nearly HKD 500 million in revenue in 2024, a growth rate exceeding 140% [3][20]. Part 2: RDC Expected to Replicate ADC Success Path - RDC shares structural and mechanistic similarities with ADC, consisting of a targeting ligand, a linker, and a radioactive nuclide [3][22]. - The report outlines that both RDC and ADC have followed similar validation timelines, with ADC gaining market traction after the success of Enhertu, while RDC is now gaining attention following the success of Pluvicto [3][22]. - The market for new nuclear drugs is projected to reach approximately $4-5 billion in 2024, comparable to the ADC market size around 2021 [3][22]. Part 3: Domestic Nuclear Drug Pipeline Overview - The report details the current pipeline of domestic nuclear drugs, with three products in the NDA stage, including Novartis's PSMA diagnostic and therapeutic drugs [3][49]. - The leading targets in domestic research remain PSMA, FAP, and SSTR, with companies like Yuan Da Pharmaceutical and Xiantong Pharmaceutical leading in clinical project numbers [3][53]. - The anticipated approval of Novartis's two PSMA-targeted products in Q2 2025 is expected to further stimulate the domestic nuclear medicine market [3][20].

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之內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不就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。 ALPHAMAB ONCOLOGY 康寧傑瑞生物製藥 （於開曼群島註冊成立的有限公司） （股份代號：9966） 自願公告 JSKN003獲得國家藥監局突破性療法認定 1 關於JSKN003 JSKN003是一種靶向HER2雙表位ADC，其通過糖基定點偶聯技術將拓撲異構酶 I抑制劑連接至抗體KN026（重組人源化抗HER2雙特異性抗體）的N糖基化位點 處。點擊反應偶聯物較馬來醯亞胺－邁克爾反應的偶聯物具有更好的血清穩定 性。雙表位HER2靶向性使JSKN003具有更強的內吞誘導及旁觀者殺傷效應，使 其在HER2表達腫瘤中具有較強的抗腫瘤活性。 關於本公司 本公司是一家中國領先的生物製藥公司，在雙特異性抗體、多功能蛋白質工程及 ADC方面擁有完善的專有技術平台。本公司高度差異化的內部管線由處於不同研 發階段的腫瘤單克隆抗體、雙特異性抗體及ADC組成，包括一種已獲國家藥監局 批准上市及三種處於臨床後期階段的藥 ...