Investment Rating - The investment rating for the company is "Buy" (maintained) [3][7]. Core Insights - The company has turned a profit in the first half of 2024, with revenue of 1.38 billion yuan, a 32.2% increase from 1.046 billion yuan in the same period of 2023. The net profit reached 310 million yuan, compared to a loss of 31.13 million yuan in the previous year [3][4]. - The revenue composition includes 1.378 billion yuan from licensing and collaboration agreements, and 4.813 million yuan from research services, with significant growth driven by collaboration with Merck [3][4]. - The company has established a new collaboration with Merck for SKB571, receiving a prepayment of 37.5 million USD, and has had the NDA for SKB264 accepted for a new indication [3][4]. Revenue and Financial Performance - The company reported a total revenue of 1.378 billion yuan in 24H1, with a year-on-year growth of 32.2% [3][4]. - The adjusted net profit for the same period was 386 million yuan, indicating a significant turnaround from the previous year's loss [3][4]. - Cash and financial assets stood at 2.89 billion yuan, indicating a strong financial position [3]. Research and Development Progress - The core pipeline SKB264 is progressing well globally, with multiple NDAs accepted and ongoing clinical trials for various indications [4]. - The company is pursuing both large and small molecule research, with several NDAs expected to be approved soon, indicating a balanced approach to short-term and long-term growth [4]. - Merck has initiated 10 Phase III studies covering major indications, which may lead to further expansion of the company's pipeline [4]. Earnings Forecast and Valuation - The company is expected to generate total revenues of 1.739 billion yuan, 1.479 billion yuan, and 2.715 billion yuan for the years 2024, 2025, and 2026 respectively [4]. - The company maintains a rich pipeline of innovative products and is progressing well globally, justifying the "Buy" rating [4].

Investment Rating - The report maintains a "Buy" rating for the company [2][4]. Core Insights - The company exceeded expectations in both licensing revenue and R&D progress, achieving a turnaround in profit for the first half of 2024 with revenue of 1.383 billion yuan, a year-on-year increase of 32.2% [4][5]. - The company has submitted its first NDA for a lung cancer indication, indicating accelerated progress in its R&D pipeline [4][5]. - The collaboration with Merck has been optimized, with the company receiving a $37.5 million upfront payment for the SKB571 project, while retaining rights in Greater China [5]. Revenue and Financial Performance - The company reported a profit of 310 million yuan for 2024H1, marking a significant recovery from losses in 2023H1 [5]. - Revenue forecasts for 2024-2026 have been revised upwards to 1.720 billion, 1.924 billion, and 2.534 billion yuan, respectively, from previous estimates of 1.181 billion, 1.574 billion, and 2.361 billion yuan [5][7]. R&D Pipeline Progress - The core product SKB264 has received CDE approval for its first indication in lung cancer, targeting EGFRm NSCLC after failure of EGFR-TKI and platinum-based chemotherapy [5]. - Multiple potential catalysts are expected, including approvals for various indications in 2024 and 2025, such as 3L+ TNBC and PDL1 monoclonal antibody for nasopharyngeal carcinoma [5]. Market Data - The current stock price is 169.90 HKD, with a market capitalization of 37.861 billion HKD [6]. - The stock has traded within a range of 72.05 to 189.30 HKD over the past 52 weeks [6]. Financial Summary - The company has shown significant revenue growth from 32 million yuan in 2021 to an estimated 1.720 billion yuan in 2024, reflecting a compound annual growth rate of 2387.3% from 2021 to 2022 and 91.6% from 2022 to 2023 [7]. - Gross profit is projected to increase from 12 million yuan in 2021 to 1.093 billion yuan in 2024 [7].

Investment Rating - The report maintains an "outperform" rating for Kelun-Biotech (6990 HK) with a target price of HKD 200.10 per share, up 84% from the previous target of HKD 108.61 [14][18]. Core Insights - Kelun-Biotech reported H1 2024 results with revenue of RMB 1.38 billion (+32.2%), gross profit of RMB 1.08 billion (+59.4%), R&D expenditure of RMB 650 million (+33.0%), and a profit of RMB 310 million compared to a loss of RMB 31.13 million in the same period last year [9][18]. - The core product sac-TMT has initiated 10 global registrational trials, with 2 indications having submitted NDA in China. The collaboration with Merck has been optimized, reflecting a dynamic adjustment in the scope of early-stage pipelines [10][18]. - The report highlights significant clinical data from the 2024 ASCO meeting, indicating sac-TMT's potential to provide clinical survival benefits in breast cancer and non-small cell lung cancer [10][18]. Financial Performance - For H1 2024, the company achieved a revenue of RMB 1.38 billion, a gross profit of RMB 1.08 billion, and a profit of RMB 310 million, marking a significant turnaround from a loss in the previous year [9][18]. - The company has a cash and cash equivalents balance of RMB 2.89 billion as of June 30, 2024 [9][18]. Product Pipeline and Development - The core product sac-TMT is expected to be approved in China between H2 2024 and H1 2025, with multiple indications in the pipeline [10][18]. - The report outlines four development strategies for sac-TMT, including first-to-market opportunities and biomarker enrichment strategies [10][18]. - The company has four products currently in the NDA stage, expected to be approved in 2024H2-25H1, including sac-TMT and A166 (HER2 ADC) [13][18]. Collaboration and Partnerships - Merck has exercised its option for SKB571, a bispecific antibody ADC, with a payment of USD 37.5 million, while returning the global rights to SKB315 [13][18]. - The collaboration with Merck is seen as a strategic move to cover a wide range of oncology indications through differentiated ADC pipelines [13][18]. Earnings Forecast and Valuation - Revenue forecasts for 2024-2026 have been adjusted to RMB 1.76 billion, RMB 1.53 billion, and RMB 2.36 billion, reflecting a YoY growth of +14%, -13%, and +54% respectively [14][18]. - The net profit attributable to the parent company is forecasted to be -RMB 230 million, -RMB 1.01 billion, and -RMB 782 million for the same period [14][18].

21 Aug 2024 CMB International Global Markets | Equity Research | Company Update Kelun-Biotech (6990 HK) Innovative bispecific ADC product licensed to MSD Kelun-Biotech recorded RMB1.38bn (+32% YoY) revenue in 1H24, including a total of US$90mn (or RMB641mn) milestone payments from MSD regarding multiple collaborated pipelines. In 1H24, Kelun-Biotech spent RMB652mn on R&D, +33% YoY, mainly driven by an uptick in clinical trials. The company is gearing up for the near-term launch of several key assets in Chin ...

21 Aug 2024 CMB 国际全球市场 | 股票研究 | 公司更新 科伦生物技术 （ 6990 香港 ） 创新的双特异性 ADC 产品授权给 MSD (上一个 TP HK$243.38 HK$246.13) 44.6% 科伦生物技术在上半年录得 13.8 亿元人民币 （ 同比增长 32% ） 的收入 ， 包括总额 从 MSD 支付 9000 万美元 （ 或 6.41 亿元人民币 ） 的里程碑款项 ， 涉及多个 合作管道。上半年 ， 科伦生物在研发上花费了 6.52 亿元人民币 ， + 33% 同比增长 ， 主要是由于临床试验的增加。该公司正在为 近期在中国推出几项关键资产 ， 包括 sac - TMT （ TROP2 ADC ） ， A166 （ HER2 ADC ） ， A167 （ PD - L1 mAb ） 和 A140 （ 西妥昔单抗生物仿制药 ） 在 2H24 或 1H25 。在准备工作中 ， 公司组建了 110 + 的商业团队 计划到 2024 年底将销售人员扩大到约 400 名员工。 因此 ， 在 1H24 ， 该公司记录了 4100 万元人民币的销售费用 (而在 1H23 ） 。科伦生物 ...

Investment Rating - The investment rating for the company is "Buy" (maintained) [3][14]. Core Insights - The company reported excellent performance in H1 2024, with revenue reaching 1.477 billion yuan, a year-on-year increase of 41.19%, and a net profit of 310 million yuan, marking its first profit [6]. - The company has accelerated the clinical progress of its core product SKB264, which has received breakthrough therapy designation for treating locally advanced PD-L1 negative TNBC and is advancing through various clinical trials [6][8]. - A new collaboration with Merck has been established for SKB571, which is expected to enhance the company's global footprint in the ADC sector [7]. Financial Performance Summary - Revenue and Profit: In H1 2024, the company achieved revenue of 1.477 billion yuan, up 41.19% year-on-year, and a net profit of 310 million yuan, marking a turnaround from previous losses [6]. - R&D Investment: R&D expenses for H1 2024 were 652 million yuan, reflecting a 33.0% increase year-on-year [6]. - Future Projections: The company's net profit forecasts for 2024-2026 have been revised to -386 million yuan, -292 million yuan, and -93 million yuan, respectively, indicating improved expectations compared to previous estimates [6]. Product Pipeline and Regulatory Progress - SKB264 is expected to receive approval for its third-line treatment for triple-negative breast cancer in H2 2024, with additional products like A166 and A167 also anticipated to gain approvals in the near future [8]. - The first NDA application for SKB264 was accepted by the CDE in December 2023 and is undergoing priority review, positioning it to be the first domestically approved TROP2 ADC drug in China [6]. Market Position and Valuation - The company's market capitalization is approximately 37.505 billion HKD, with a circulating market value of 21.925 billion HKD [4]. - The stock has shown a significant trading volume with a turnover rate of 20.34% over the past three months [4].

Investment Rating - The report maintains a "Buy" rating for the company [2][3]. Core Insights - The company achieved revenue of 1.383 billion RMB in the first half of 2024, representing a year-on-year increase of 32.3%, primarily driven by licensing and collaboration agreements, including a milestone payment of 90 million USD from MSD [2]. - The core product SKB264 has made significant progress in clinical trials, with its first NDA submission for lung cancer and multiple ongoing studies across various indications [2]. - The company is optimizing its collaboration with MSD, which has initiated 10 global Phase III clinical studies for SKB264 and has exercised exclusive rights for the new dual-antibody ADC product SKB571 [2]. - Four products are expected to be approved and commercialized between the second half of 2024 and the first half of 2025, with a dedicated commercialization team focusing on domestic hospitals and leading physicians [2]. - The revenue forecast for the company has been adjusted upwards, with expected total revenues of 1.993 billion RMB, 2.026 billion RMB, and 3.085 billion RMB for 2024, 2025, and 2026 respectively [2]. Financial Forecasts - The company reported a gross profit of 1.077 billion RMB in the first half of 2024, a year-on-year increase of 59.4%, and a profit of 310 million RMB, with an adjusted profit of 386 million RMB, reflecting a significant increase of 1068.0% year-on-year [2]. - Research and development expenses for the first half of 2024 were 652 million RMB, up 33.0% year-on-year [2]. - The company held cash and financial assets totaling 2.885 billion RMB as of June 30, 2024 [2]. - The projected net profit for the company is expected to be -138 million RMB, -618 million RMB, and -133 million RMB for 2024, 2025, and 2026 respectively [3].

Investment Rating - The report maintains a "Buy" rating for the company, indicating an expected price increase of over 15% in the next 6-12 months [7]. Core Insights - The company reported a revenue of 1.383 billion, a year-on-year increase of 32.2%, and a gross profit of 1.077 billion, up 59.4% [2][3]. - The NDA for sac-TMT's new indication for lung cancer has been accepted, with commercialization imminent [3]. - The company has received multiple milestone payments from MSD, totaling approximately 64.1 million, contributing to a strong cash position of 2.885 billion [3]. - Revenue forecasts for 2024, 2025, and 2026 are adjusted to 1.682 billion, 1.550 billion, and 2.400 billion respectively [3]. Financial Performance - Revenue growth rates are projected at 9.19% for 2024, -7.85% for 2025, and 54.84% for 2026 [5]. - The company is expected to incur net losses of 466 million in 2024, 389 million in 2025, and is projected to achieve a profit of 138 million in 2026 [5]. - The diluted earnings per share are forecasted to improve from -2.09 in 2024 to 0.62 in 2026 [5]. Clinical Development - MSD has initiated ten international Phase III clinical trials for sac-TMT, covering multiple cancer indications [3]. - The company is advancing two Phase III registration studies for sac-TMT in breast cancer and NSCLC [3]. Cash Position and Funding - The company raised approximately 541 million HKD through a placement in May 2024, enhancing its cash reserves [3]. - As of mid-2024, the company holds cash and equivalents of about 2.885 billion, ensuring stable operations [3].

Investment Rating - Buy (Maintained) [1] Core Views - The company's 2024 H1 revenue reached 1.38 billion yuan, a year-on-year increase of 32.2%, with Merck milestone payments contributing 640 million yuan [2] - Net profit for H1 2024 was 310 million yuan, marking a temporary profitability [2] - Cash and financial assets totaled 2.89 billion yuan, indicating sufficient capital reserves [2] - SKB264, the first domestic Trop2 ADC, is expected to be approved in China in H2 2024 or H1 2025, with potential inclusion in next year's medical insurance negotiations [3] - Multiple products, including A166 (HER2 ADC), SKB315 (CLDN 18.2 ADC), and SKB410 (Nectin-4 ADC), are progressing well and expected to enter the commercialization phase [3] - Merck exercised its option for the global rights (excluding Greater China) of the bispecific ADC product SKB571, paying a $37.5 million upfront fee with additional development and sales milestones [3] Financial Performance and Forecasts - Revenue for 2024E, 2025E, and 2026E is forecasted at 1.602 billion yuan, 1.447 billion yuan, and 2.003 billion yuan, respectively [2] - Net profit attributable to the parent company for 2024E, 2025E, and 2026E is projected at -376.31 million yuan, -921.17 million yuan, and -795.16 million yuan, respectively [2] - EPS for 2024E, 2025E, and 2026E is estimated at -1.69 yuan, -4.13 yuan, and -3.57 yuan, respectively [2] - Operating cash flow for 2024E is forecasted at 2.197 billion yuan, while investment and financing cash flows are expected to be 15.21 million yuan and 689.50 million yuan, respectively [9] Product Pipeline and Clinical Progress - SKB264 has initiated 10 global Phase 3 clinical trials overseas, covering multiple indications in lung cancer, breast cancer, endometrial cancer, cervical cancer, and gastroesophageal adenocarcinoma [3] - A166 (HER2 ADC) has completed NDA submission for its first indication (HER2+ BC, 3L+) and is expected to be launched in H2 2024 or H1 2025 [3] - SKB571, a bispecific ADC targeting lung cancer and gastrointestinal tumors, is expected to submit an IND application soon [3] Valuation and Market Data - The closing price as of the report date was HK$169.40, with a 52-week range of HK$62.00 to HK$195.00 [5] - The P/B ratio is 11.76x, and the market capitalization is HK$22.07 billion [5] - The company's ROE for 2024E, 2025E, and 2026E is forecasted at -19.06%, -85.82%, and -266.03%, respectively [10] Platform and Strategic Developments - The OptiDC platform's value is further validated by Merck's exercise of the option for SKB571, highlighting the company's innovative capabilities in ADC development [3] - The company is transitioning into a commercialization phase with multiple products nearing market entry, supported by a robust pipeline and strategic partnerships [3]

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的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不對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。 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. 四川科倫博泰生物醫藥股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：6990） 截至2024年6月30日止六個月的中期業績公告 董事會欣然宣佈本集團截至2024年6月30日止六個月的未經審計簡明綜合中期業 績，連同截至2023年6月30日止六個月的比較數字。本公司獨立核數師已根據香 港審閱工作準則第2410號「實體獨立核數師審閱中期財務資料」對中期財務資料進 行審閱。除本公告另有界定外，本公告所用詞彙與招股章程所界定者具有相同涵 義。 | --- | --- | --- | --- | |---------------------------|--------------------------------------------------|-------------------- ...