Core Viewpoint - Kolon Biotech Inc. (06990) shares rose nearly 5%, currently up 3.42% at 436 HKD, with a trading volume of 88.67 million HKD, following the announcement of multiple clinical research results at the ESMO conference held in Berlin from October 17 to 21, 2025 [1] Group 1: Clinical Research Results - The company's core product SKB264 was selected for two oral presentations at ESMO, demonstrating BIC potential in the treatment of EGFRm NSCLC in the 2L+ setting, with good safety profile; the indication was approved for market in October [1] - SKB264 showed significantly better results than chemotherapy for HR+/HER2- BC in the 2L+ treatment, with expectations for approval in 2026 [1] - Clinical data for the core product A166 indicated that it surpassed T-DM1 in the treatment of HER2+ BC in the 2L+ setting, with this indication also approved for market in October [1]

Core Viewpoint - Keren Biotechnology-B (06990) has seen a stock increase of nearly 5%, currently trading at 436 HKD with a transaction volume of 88.67 million HKD, following the announcement of multiple clinical research results at the ESMO conference in Berlin from October 17 to 21, 2025 [1] Group 1: Clinical Research Results - The company's core product SKB264 was selected for two oral presentations at ESMO, demonstrating BIC potential in the treatment of EGFRm NSCLC in the 2L+ setting, with good safety profile; the indication was approved for market in October [1] - SKB264 showed significantly better results than chemotherapy for HR+/HER2- BC in the 2L+ treatment, with expectations for approval in 2026 [1] - Clinical data for the core product A166 was announced, showing that it outperformed T-DM1 in the treatment of HER2+ BC in the 2L+ setting, with this indication also approved for market in October [1]

Investment Rating - The report maintains a "Positive" investment rating for the pharmaceutical and biotechnology industry in China [5]. Core Insights - The ESMO conference showcased significant breakthroughs in both foreign and domestic innovative drugs, highlighting the competitive strength of Chinese pharmaceutical companies on the international stage [3][12]. - The report emphasizes the potential of domestic innovative drugs to redefine standard therapies, particularly in the context of PD-1/VEGF dual antibodies and antibody-drug conjugates (ADCs) [8][29]. Summary by Sections 1. PD-1 plus and Domestic Dual Antibodies - The PD-(L)1/VEGF dual antibody, Ivosidenib, demonstrated strong positive results in a Phase III trial for first-line treatment of advanced squamous non-small cell lung cancer (NSCLC), showing a progression-free survival (PFS) improvement of 4.2 months compared to the PD-1 group [13][16]. - SSGJ-707, a PD-1/VEGF dual antibody, showed promising results in treating microsatellite stable (MSS) colorectal cancer, with an overall response rate (ORR) of 68.7% and a disease control rate (DCR) of 98.5% [18][19]. - HB0025, another PD-L1/VEGF dual antibody, reported an ORR of 83.3% in squamous NSCLC patients, indicating strong anti-tumor efficacy [20][21]. 2. ADCs: Accelerated Breakthroughs - SKB264, an ADC, has shown significant PFS and overall survival (OS) benefits in a Phase III trial for EGFR-mutant NSCLC, with PFS HR of 0.49 and OS HR of 0.60, indicating its potential as a new standard therapy [29][30]. - In the breast cancer domain, SKB264 demonstrated an ORR of 41.5% in CDK4/6i pre-treated HR+/HER2- advanced breast cancer, significantly outperforming chemotherapy [31][32]. - The report highlights the global potential of SKB264, with ongoing studies expected to further validate its efficacy and safety profile [23][29].

Core Viewpoint - Bank of America Securities has raised the target price for Kelun-Biotech from HKD 471.5 to HKD 522, maintaining a "Neutral" rating, citing encouraging clinical progress but limited short-term authorization opportunities [1] Clinical Progress - The report highlights significant improvements in progression-free survival (PFS) data for sac-TMT and A166, which contributed to the upward revision of the target price [1] - The National Medical Products Administration has recently approved sac-TMT for second-line treatment of EGFR mutation non-small cell lung cancer (NSCLC) and A166 for second-line and above HER2-positive breast cancer (BC) [1] Revenue Forecast - Revenue forecasts for 2025 to 2027 have been increased by 1% to 5%, reflecting the positive clinical developments and long-term projections [1]

Core Viewpoint - The announcement from Kelun Pharmaceutical indicates that its subsidiary, Sichuan Kelun Botai Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration (NMPA) for its antibody-drug conjugate (ADC) A166 (also known as Shutailai®) for the treatment of adult patients with HER2-positive breast cancer who have previously received one or more anti-HER2 therapies [2] Group 1 - The approved drug A166 targets the human epidermal growth factor receptor 2 (HER2) [2] - The indication for A166 is for patients with unresectable or metastatic HER2-positive breast cancer [2] - The approval is significant as it addresses a patient population that has limited treatment options after prior therapies [2]

Core Viewpoint - The company, Kelun Pharmaceutical, announced that its subsidiary, Sichuan Kelun Botai Biopharmaceutical Co., Ltd., received approval from the National Medical Products Administration (NMPA) for its antibody-drug conjugate (ADC) A166 (also known as Trastuzumab deruxtecan) for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have previously received one or more anti-HER2 therapies [1] Group 1 - The ADC A166 targets the human epidermal growth factor receptor 2 (HER2) [1] - The approval is specifically for patients with unresectable or metastatic HER2-positive breast cancer [1] - The indication is for those who have previously undergone treatment with one or more anti-HER2 drugs [1]

Summary of Kelun Biotech Conference Call Company Overview - **Company**: Kelun Biotech (6990.HK) - **Industry**: Biotechnology, specifically focusing on antibody-drug conjugates (ADCs) Key Points 1. Strong Sales Growth - Significant sales ramp-up for sac-TMT (TROP2 ADC) observed in Q2, primarily driven by 3L EGFRmut NSCLC following NMPA approval in March - First commercial interim results reported at Rmb302 million for sac-TMT, on track to meet FY25 guidance of Rmb800 million to Rmb1 billion - Achieved commercial profitability in H1 2025, with drug sales surpassing SG&A expenses, and expects firmwide profitability in the near term due to licensing income from MSD partnership, estimated at US$100 million to US$150 million per year [3][4][8] 2. Upcoming Data Presentation at ESMO 2025 - ESMO 2025 (October 17-21) is anticipated to be a data-rich event for Kelun Biotech - Management highlighted three LBA presentations, including: - Clinical readouts from Phase 3 studies of sac-TMT in 2L EGFRmut NSCLC and HR+/HER2- breast cancer - Phase 3 head-to-head study of A166 (HER2 ADC) versus T-DM1 - POC-stage data for various tumor types, including ph2 ORR data of sac-TMT combined with Keytruda in 1L PD-L1+ NSCLC [4][7] 3. Early Pipeline Developments - Kelun Biotech is progressing its early-stage ADC pipeline, including: - SKB410 (Nectin-4 ADC, Phase 2 global study led by MSD) - SKB518 (PTK7 ADC, Phase 1b/2) showing early anti-tumor signals in NSCLC and SCLC - SKB571 (EGFR/c-Met ADC, Phase 1) undergoing dose-escalation trials - Management prefers to release data with certain maturity to provide a comprehensive drug profile [7][8] 4. Investment Rating and Price Target - Goldman Sachs maintains a Buy rating on Kelun Biotech with a 12-month price target of HK$454.04 - Current price is HK$491.40, indicating a downside potential of 7.6% - Key risks include R&D challenges, competition in the ADC field, limited commercial track record, talent competition, and partnership risks [8][9] 5. Financial Projections - Market cap: HK$114.6 billion (approximately US$14.7 billion) - Revenue projections for the next few years: - 2024: Rmb1,933 million - 2025E: Rmb1,950.6 million - 2026E: Rmb3,579.7 million - 2027E: Rmb5,432.9 million - EBITDA projections show a turnaround from negative to positive by 2026 [9] Additional Insights - The company is focusing on achieving greater visibility into the differentiated profiles and treatment potential of its next-generation assets through upcoming data releases [7] - The management's emphasis on commercial profitability and the strategic partnership with MSD indicates a strong outlook for future growth in the ADC market [3][4][8]

Investment Rating - The report maintains a "Buy" rating for the company, expecting a price increase of over 15% in the next 6-12 months [5][13]. Core Insights - The company reported a revenue of 950 million yuan for the first half of 2025, with a net loss of 145 million yuan [2]. - The commercialization year has begun, with sales starting to ramp up. The company has three products approved for sale: Jiatailai (TROP2 ADC), Ketailai (PD-L1 monoclonal antibody), and Datailai (Cetuximab) [3]. - The company has a strong clinical pipeline, with Jiatailai's core clinical layout entering a harvest period, and several key indications in various stages of clinical trials [4]. Financial Performance - The company is expected to achieve revenues of 2.325 billion yuan, 3.668 billion yuan, and 5.352 billion yuan for the years 2025, 2026, and 2027 respectively, showing significant growth compared to previous forecasts [5]. - The projected net profit for 2027 is 380 million yuan, indicating a turnaround from previous losses [5]. - The revenue growth rates are projected at 20.29%, 57.74%, and 45.91% for the years 2025, 2026, and 2027 respectively [10]. Clinical Development - The company has a robust pipeline with several products in various stages of clinical development, including A166 (HER2 ADC) in NDA stage and A400 (RET inhibitor) in registration clinical stage [4]. - The company is expanding its market reach, with products already covering 30 provinces and over 2000 hospitals [3]. Market Potential - The inclusion of Jiatailai, Ketailai, and Datailai in the basic medical insurance directory is expected to accelerate sales growth [3]. - The market potential for TROP2 ADC in breast and lung cancer is significant, with comprehensive coverage of patients anticipated upon completion of ongoing clinical trials [3].

Financial Data and Key Metrics Changes - The company reported a revenue of RMB950 million for the first half of 2025, with over RMB300 million coming from commercialized drugs, marking a significant achievement in its first year of commercialization [50][51] - Gross profit was RMB660 million, comparable to the previous year, while the net loss for the first half was RMB145 million, with an adjusted loss of RMB69 million after one-off budget adjustments [52][53] Business Line Data and Key Metrics Changes - The company has three main products ready for the market, with significant progress in approvals and commercialization efforts [12][21] - The commercialization team has expanded to nearly 400 personnel to support the increasing number of products [12] Market Data and Key Metrics Changes - The company has covered over 30 provinces, 300 cities, and over 1,000 hospitals across China, with partnerships established with over 400 pharmacies [28][32] - The company is actively working towards gaining medical insurance coverage for its products, which is expected to enhance market access [33][34] Company Strategy and Development Direction - The company aims to advance differentiated pipelines targeting significant medical needs, optimizing payload linker strategies, and exploring applications in non-oncology areas [26] - The focus is on expanding global partnerships and strengthening strategic collaborations to maximize the value of its pipelines [26] Management Comments on Operating Environment and Future Outlook - Management expressed optimism about the future income from sales revenue, anticipating continued cash flow generation from both R&D partnerships and commercialized drugs [51] - The company is preparing for the implementation of new medical insurance policies, which could significantly impact product sales strategies [97][100] Other Important Information - The company completed a follow-on financing of US$250 million and is included in several global equity indexes, enhancing its financial stability [25] - The company is involved in ongoing litigation regarding IP disputes with several founders, which has been accepted for review by the Sichuan Provincial High Court [101] Q&A Session Summary Question: What is the breakdown of sales revenue for breast cancer and lung cancer? - Lung cancer is the biggest contributor to sales revenue, consistent with patient numbers and indications. The sales expenses are expected to decrease once products are included in medical insurance coverage [62][63] Question: What is the focus for R&D going into the next stage? - The focus is on developing differentiated products targeting clinical demands, with an emphasis on bispecific targets and new payload strategies [68][70] Question: Can you provide guidelines on the sales trend for Q3? - The company expects quarter-over-quarter growth, with significant contributions anticipated from lung cancer indications [72] Question: What is the rationale behind the clinical trial design for PD L1 positive and negative patients? - The company is focusing on first-line treatment for wild-type non-small cell lung cancer, with ongoing projects in development [88] Question: How is the company planning to navigate the new medical insurance policy? - The company is prioritizing entry into the medical insurance catalog and is actively preparing to comply with the new policy [97][98]

Financial Data and Key Metrics Changes - The company reported a revenue of RMB 950 million for the first half of 2025, with over RMB 300 million coming from commercialized drugs, marking a significant achievement in its first year of commercialization [52][53]. - The gross profit was RMB 660 million, comparable to the previous year, while the net loss for the first half was RMB 145 million, with an adjusted loss of RMB 69 million after one-off budget adjustments [54][55]. - Cash and financial assets totaled RMB 4.5 billion, indicating a healthy financial status to support upcoming R&D and innovation [58]. Business Line Data and Key Metrics Changes - The company has three main products ready for the market, with significant progress in commercialization, covering over 30 provinces and 300 cities, and engaging over 10,000 doctors [32][34]. - The commercialization team has expanded to nearly 400 personnel to support the increasing number of products ready for market [14][15]. Market Data and Key Metrics Changes - The company has successfully partnered with over 400 pharmacies across China, enhancing its market access and professional services [32][34]. - The company is actively pursuing medical insurance coverage for its products, with seven provinces already covered under specific affordable care programs [36][37]. Company Strategy and Development Direction - The company aims to advance differentiated pipelines targeting significant medical needs, optimizing payload linker strategies, and exploring applications in non-oncology areas [30]. - The focus is on developing ADCs and small molecules, with an emphasis on bi-specific targets and innovative payloads to replace traditional chemotherapy [70][72]. Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future income from sales revenue, anticipating continued cash flow generation from both R&D partnerships and commercialized drugs [53]. - The company is preparing for the implementation of new medical insurance policies, which are expected to enhance market access and sales volume [100][101]. Other Important Information - The company has completed a follow-on financing of USD 250 million and is included in major global equity indexes, enhancing its market presence [29]. - The company has made significant advancements in clinical trials, with multiple pivotal trials initiated both domestically and globally [25][26]. Q&A Session Summary Question: What is the breakdown of sales revenue for breast cancer and lung cancer? - Lung cancer is the biggest contributor to sales revenue, consistent with patient numbers and indications. The sales expenses are expected to decrease once products are included in the national medical insurance catalog [60][64]. Question: What is the focus for R&D going into the next stage? - The focus is on developing differentiated products targeting clinical demands, with an emphasis on bi-specific targets and innovative payloads [70][72]. Question: Can you provide guidelines on the sales trend for Q3? - The company has recorded quarter-over-quarter growth of several dozen percentage points, indicating a positive sales trend [76]. Question: What is the rationale behind the clinical trial design for PD L1 positive and negative patients? - The company is focusing on developing effective treatments for both PD L1 positive and negative patients, with ongoing trials to assess efficacy [91]. Question: How does the company plan to navigate the new medical insurance policies? - The company is prioritizing entry into the medical insurance catalog and is actively preparing to comply with new policies to enhance market access [100][101].