The Stock Exchange of Hong Kong Limited and the Securities and Futures Commission take no responsibility for the contents of this Application Proof, make no representation as to its accuracy or completeness and expressly disclaim any liability whatsoever for any loss howsoever arising from or in reliance upon the whole or any part of the contents of this Application Proof. Application Proof of Shaanxi Micot Pharmaceutical Technology Co., Ltd. 陝西麥科奧特醫藥科技股份有限公司 (the "Company") (A joint stock company incorpora ...

香 港 聯 合 交 易 所 有 限 公 司 及 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 聲 明，並 明 確 表 明 概 不 就 因 本 申 請 版 本 全 部 或 任 何 部 分 內 容 而 產 生 或 因 依 賴 該 等 內 容 而 引 致 的 任 何 損失承擔任何責任。 Shaanxi Micot Pharmaceutical Technology Co., Ltd. 陝西麥科奧特醫藥科技股份有限公司 （「本公司」） （於中華人民共和國註冊成立的股份有限公司） 之申請版本 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、 接納並向本公司、本公司的聯席保薦人、聯席整體協調人、顧問或包銷團成員表示同意： 倘 於 適 當 時 候 向 香 港 公 眾 人 士 提 出 要 約 或 邀 請，準 投 資 ...

Group 1 - Company announced an exclusive commercialization agreement with Maikouote for the new drug MT1013, aimed at treating secondary hyperparathyroidism (SHPT), with a transaction value of up to 1.24 billion RMB (179 million USD) [2] - The agreement includes an upfront payment of 200 million RMB and potential milestone payments of up to 1.04 billion RMB, with ongoing Phase III clinical trials funded by Maikouote [2] - The company also received approval from the National Medical Products Administration of China for its drug Velsipity, which treats moderate to severe active ulcerative colitis (UC) in adults who do not respond adequately to traditional treatments [2][3] Group 2 - Velsipity is a new generation high-selectivity S1P receptor modulator, approved based on two Phase III studies demonstrating statistical significance and clinical relevance across all primary and secondary efficacy endpoints [3] - Following these announcements, the company's stock price increased by 5.5% over two trading days, with a year-to-date increase of 7.2% [4]

Investment Rating - The report maintains a positive outlook on the pharmaceutical industry, indicating an "Overweight" rating, suggesting that the industry is expected to outperform the overall market [2][33]. Core Insights - The pharmaceutical sector saw a slight increase of 0.14% in the week, while the Shanghai Composite Index decreased by 1.27% [3][2]. - The report highlights the implementation of the "Traditional Chinese Medicine Industry High-Quality Development Implementation Plan (2026-2030)" by the Ministry of Industry and Information Technology and other departments, aiming to enhance the supply chain and technological advancements in the traditional Chinese medicine sector [11][12]. - Key pharmaceutical products such as Eli Lilly's Tirzepatide are projected to generate significant sales, with estimates of $36.5 billion in 2025, reflecting a 99% year-on-year growth for the diabetes version and a 175% growth for the weight loss version [15][17]. - The report notes active licensing and collaboration in the industry, with significant deals such as a $1.5 billion agreement between Saint's RNAi therapy and Genentech, and various other collaborations involving companies like Jichuan Pharmaceutical and Baiyunguan [18][20]. Market Performance Summary - The overall valuation of the pharmaceutical sector is reported at 29.6 times earnings, ranking 13th among 31 sectors [4][14]. - The performance of various sub-sectors includes: - Raw materials (+0.6%) - Traditional Chinese Medicine (+2.6%) - Chemical preparations (-0.8%) - Medical devices (+0.1%) [4][3]. Key Events and Developments - The report emphasizes the importance of the new plan for traditional Chinese medicine, which includes goals such as establishing 60 high-standard raw material production bases and developing 10 major traditional Chinese medicine products by 2030 [12][11]. - Notable company developments include: - Eli Lilly's projected revenue growth driven by Tirzepatide [15]. - And the announcement of significant profit forecasts from Heptares Pharmaceuticals, indicating a shift towards profitability [16]. Investment Recommendations - The report suggests focusing on domestic companies related to traditional Chinese medicine, such as Zoli Pharmaceutical and Yunnan Baiyao, as well as innovative drug companies like Heng Rui Pharmaceutical and Bai Jie Shen Zhou [2][18].

Core Insights - The approval of VELSIPITY (Arginine Eculizumab Tablets) by the NMPA marks a significant advancement in the treatment of moderate to severe active ulcerative colitis (UC) in adults, addressing a critical gap in the market for patients unresponsive to traditional therapies [1][2][4] Group 1: Product Overview - VELSIPITY is a next-generation high-selectivity S1P receptor modulator, designed for once-daily oral administration, offering rapid onset and effective deep mucosal healing, with a strong safety profile [1][3] - The drug is projected to reach peak sales of 5 billion RMB, positioning it as a core product for the company following its success with renal disease treatment [1][6] Group 2: Market Context - The incidence of ulcerative colitis in China is rising, with an expected increase in patient numbers from approximately 980,000 in 2025 to about 1.5 million by 2031, highlighting the urgent need for effective treatments [2] - Current treatment options are limited, with existing therapies facing challenges such as limited efficacy, high relapse rates, and adverse reactions [2][5] Group 3: Clinical Efficacy - Clinical trials have demonstrated VELSIPITY's significant efficacy, with a clinical remission rate of 48.1% and a mucosal healing rate of 51.9% over 40 weeks of maintenance treatment [3][4] - The drug has been recognized in multiple international guidelines as a first-line treatment for ulcerative colitis, underscoring its clinical value [4] Group 4: Commercialization Strategy - The company has established a comprehensive A2MS operational system to facilitate the market entry of VELSIPITY, leveraging its scientific and commercial insights [5][6] - VELSIPITY is set to be included in the urgent import drug directory for clinical use in the Greater Bay Area in 2024, providing a first-mover advantage [6][7] Group 5: Financial Outlook - The approval of VELSIPITY enhances the company's revenue structure, with expectations of significant growth in revenue and profitability as it expands its product portfolio [6][7] - The company aims to achieve over 15 billion RMB in revenue by 2030, driven by a combination of existing and new product sales, with a projected compound annual growth rate exceeding 50% from 2025 to 2030 [7]

Core Insights - The approval of VELSIPITY® (Argenine Acquimod Tablets) by the NMPA marks a significant milestone for the company in the autoimmune field, providing a new first-line treatment option for adult patients with moderate to severe active ulcerative colitis (UC) who have inadequate response to traditional therapies or biologics [1][2] - The company aims to commercialize VELSIPITY® quickly and is actively working to include it in the national medical insurance directory, aligning with its 2030 development strategy focused on dual-driven growth through BD collaboration and self-research [2][4] Group 1: Product and Clinical Research - VELSIPITY® is a next-generation high-selectivity sphingosine-1-phosphate (S1P) receptor modulator, administered once daily, demonstrating rapid onset and strong mucosal healing with good safety characteristics [1] - The approval is based on results from the largest Asian Phase III registration clinical study (ENLIGHTUC) involving 340 patients, as well as global Phase III studies (ELEVATEUC52 and ELEVATEUC12) that confirmed the drug's favorable benefit-risk profile [1][2] Group 2: Commercialization Strategy - The company has established a commercialization platform with three products and is focused on building a comprehensive commercialization system and drug lifecycle management capabilities [3] - Revenue targets include exceeding 10 billion RMB by 2028 and over 15 billion RMB by 2030, with an expected compound annual growth rate of over 50% from 2025 to 2030 [3] Group 3: Future Growth and Strategic Goals - The 2030 development strategy emphasizes a dual-driven approach of BD collaboration and self-research, aiming to introduce 3 to 5 late-stage blockbuster products annually and achieve peak sales within three years post-reimbursement [4] - The company plans to introduce over 20 high-value assets by 2030, contributing approximately 6 billion RMB in revenue, with a long-term goal of reaching around 30 billion RMB by 2035 [4]

Core Insights - The approval of Velsipity (Arginine Acumod Tablets) by the NMPA marks a significant milestone for the company in establishing its leading position in the autoimmune field [1][3] - Velsipity is a new generation high-selectivity S1P receptor modulator that offers a new first-line treatment option for adult patients with moderate to severe active ulcerative colitis [2] - The company aims to commercialize Velsipity quickly and push for its inclusion in the national medical insurance directory as part of its 2030 development strategy [3] Clinical Research - The approval is based on results from the ENLIGHT UC study, the largest Phase III registration clinical trial for moderate to severe active ulcerative colitis patients in Asia, involving 340 patients [2] - Velsipity demonstrated statistical significance and clinical relevance in all primary and secondary efficacy endpoints during the 12-week induction and 40-week maintenance treatment periods [2] - The ELEVATE UC Phase III studies further validated Velsipity's favorable benefit-risk profile [2] Commercialization Strategy - The company has laid out plans to establish a comprehensive commercialization system and aims to achieve revenue exceeding 10 billion RMB by 2028 and over 15 billion RMB by 2030 [4] - The revenue growth rate is projected to exceed 50% from 2025 to 2030, with a target of maintaining over 15% growth post-2030 [4] - The number of commercialized products is expected to increase to over 20, including Velsipity and other key products [4] Future Development Plans - The 2030 development strategy signifies a crucial milestone for the company in advancing towards the forefront of global biopharmaceuticals [5] - The company plans to introduce 3 to 5 late-stage blockbuster products annually and aims to contribute 6 billion RMB in revenue from over 20 high-value assets by 2030 [5] - The strategic focus will be on maintaining leadership in core therapeutic areas and innovative drug development, aiming to become a leading comprehensive biopharmaceutical company globally [5]

Core Viewpoint - The strategic partnership between Macao and Yunding Xinyao grants the latter exclusive commercialization rights for the innovative dual-target peptide drug MT1013 in China and the Asia-Pacific region (excluding Japan), marking a significant step in the company's global expansion and realization of innovative drug value [1][6]. Group 1: Strategic Partnership - Macao has officially announced a strategic collaboration with Yunding Xinyao, granting exclusive commercialization rights for MT1013 [1][6]. - The agreement includes an upfront payment of 200 million RMB and potential milestone payments up to 1.04 billion RMB, indicating a strong financial incentive for both parties [1][6]. Group 2: Drug Innovation and Mechanism - MT1013 is a first-in-class peptide drug developed by Macao, targeting both calcium-sensing receptor (CaSR) and osteogenic growth peptide (OGP) pathways, representing a shift from passive bone resorption inhibition to active bone formation promotion [2][7]. - The drug aims to comprehensively regulate PTH secretion, correct calcium and phosphorus metabolism, and directly enhance bone health [2][7]. Group 3: Clinical Data and Efficacy - Key Phase II clinical trial data for MT1013 demonstrate significant efficacy and therapeutic potential, with a Phase III registration trial currently underway for SHPT patients undergoing maintenance hemodialysis [4][10]. - MT1013 shows superior performance in achieving triple targets of iPTH, blood calcium, and blood phosphorus levels, along with excellent phosphorus-lowering effects and a significant reduction in cardiovascular risk marker FGF-23 [8][10]. - After 52 weeks of treatment, patients exhibited significant improvements in bone density and sustained enhancements in bone metabolism markers [8][10].

Core Insights - CloudTop New Medicine (HKEX: 1952.HK) has entered into a licensing agreement with Micot to acquire the candidate drug MT1013 for Secondary Hyperparathyroidism (SHPT) with an upfront payment of 200 million RMB and potential milestone payments up to 1.04 billion RMB [1][3] - The acquisition aims to enrich the company's renal disease product line and secure high-potential innovative assets, particularly as the existing core product, Renfukang, has limited long-term revenue stability due to a small patient population [1][2] Group 1: Product and Market Strategy - The introduction of MT1013 complements the existing product portfolio, targeting a significant patient population in chronic kidney disease (CKD) and enhancing commercial efficiency through the existing sales team [2][3] - MT1013 is designed to address the shortcomings of current SHPT treatments, which often lead to gastrointestinal side effects and bone quality deterioration, by targeting both calcium-sensing receptors (CaSR) and osteogenic growth peptide (OGP) pathways [2][4] - The global chronic kidney disease drug market is projected to grow from $15.92 billion in 2025 to $23.02 billion by 2032, with a compound annual growth rate (CAGR) of 5.4% from 2025 to 2032, indicating a strong market opportunity for innovative treatments like MT1013 [3][4] Group 2: Competitive Landscape - The market is shifting from single-target drugs to differentiated innovative assets, with MT1013's dual-target design meeting the industry's demand for unique mechanisms of action [4][5] - The evaluation criteria for drug efficacy are evolving from focusing solely on single metrics to a comprehensive assessment of overall health benefits for patients, which is becoming a key competitive factor in the innovative drug market [5][6] - The trend towards multi-target therapies is gaining traction in CKD research, as the complexity of disease mechanisms necessitates a more holistic approach to treatment [5][6] Group 3: Implications for Stakeholders - The transaction reflects a trend towards more specialized roles within the pharmaceutical industry, where developers focus on technical advancements while commercial entities concentrate on market realization [6][7] - For innovative entrepreneurs, maintaining a clinical demand orientation and establishing differentiated barriers is crucial, as is anticipating commercial competition and designing robust clinical trial data [6][7] - For investment institutions, prioritizing late-stage assets with head-to-head data and focusing on high-demand areas like SHPT can mitigate risks associated with research failures [6][7]

Group 1 - The core viewpoint of the news is that CloudTop New Medicine has signed an exclusive commercialization license agreement with Macao to obtain global rights for the innovative dual-target peptide drug MT1013 in China and the Asia-Pacific region (excluding Japan) [1][2] - CloudTop will pay Macao a signing fee of 200 million RMB and potential regulatory and commercial milestone payments of up to 1.04 billion RMB [1] - The collaboration is a strategic move for CloudTop to enhance its innovative pipeline and expand its treatment capabilities in nephrology, creating a strong synergistic effect with its existing nephrology pipeline [1][2] Group 2 - The chairman of CloudTop, Wu Yifang, emphasized the significant unmet clinical needs in secondary hyperparathyroidism (SHPT) against the backdrop of a rising number of chronic kidney disease patients globally [2] - MT1013 is expected to provide a new treatment option for SHPT patients, positioning it as a potential best-in-class drug that will synergize with the company's existing nephrology product portfolio [2] - The partnership marks a shift in CloudTop's nephrology strategy from focusing on a single disease to a more systematic and platform-based approach, aiming to expand into broader treatment areas such as glomerulonephritis and chronic kidney disease and its complications [2]