Financial Data and Key Metrics Changes - The company reported a full year 2024 revenue of RMB706.7 million, reflecting a significant 461% year-on-year growth, exceeding the guidance of RMB700 million [6][22] - Gross margin on a cash basis was 83% for the full year 2024, indicating strong operational efficiency [6][23] - Non-IFRS net loss narrowed to approximately RMB537.6 million, down by 25% year-on-year [7][24] - Cash balance stood at RMB1.6 billion, providing flexibility for future growth [8][25] Business Line Data and Key Metrics Changes - Total product revenue reached RMB706.7 million, with Nephicom generating RMB353.4 million, representing a year-on-year growth of 1581% [9][10] - Cerava contributed RMB252.8 million in revenue, marking a 256% increase year-on-year [10] - Distribution and selling expenses increased to RMB508.1 million, but the commercial expense to revenue ratio decreased significantly by 111.9 percentage points [24] Market Data and Key Metrics Changes - The company has successfully listed Natricon in the National Reimbursement Drug List (NRDL), which is expected to enhance patient access and drive growth [11][32] - Over 10,000 new IgAN patients have been prescribed Nephicom since its NRDL inclusion [68] - The company plans to expand its sales organization to 200 sales representatives to cover 80% of the addressable market potential [34] Company Strategy and Development Direction - The company aims to achieve cash level breakeven by the end of 2025, focusing on a dual engine growth strategy that includes strong commercial execution and internal developments [9][26] - The first engine focuses on a China-centric commercial platform with key products like Nephicom, XERAVA, and Valsivity, while the second engine emphasizes in-house R&D for innovative therapeutics [27][28] - The company is committed to expanding its pipeline in renal diseases and infectious diseases, with a focus on innovative therapeutics and diagnostics [29][35] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's transformation from a biotech to a biopharma company, highlighting the strong revenue generation from continuing operations [26][89] - The company is optimistic about the future growth potential, particularly with the expected approval of key products and the expansion of its commercial infrastructure [28][62] - Management noted the importance of generating real-world evidence to support product positioning and adoption in the market [71][83] Other Important Information - The company has made significant advancements in its pipeline, including the development of mRNA cancer vaccines and in vivo CAR T programs [47][56] - The company has received U.S. IND approval for its personalized cancer vaccine program, marking a significant milestone [54] Q&A Session Summary Question: Can you share more on the NRDL implementations and competition in IgAN? - Management reported that over 10,000 new IgAN patients have been prescribed Nephicom since NRDL inclusion, with ongoing efforts to expand the sales team to better cover target hospitals [68][70] - The company believes Nephicom's unique profile and clinical data will position it favorably against emerging competition in the IgAN market [70][72] Question: What feedback has been received regarding etrasimod and its usage? - Early feedback from doctors and patients in the Great Bay Area has been positive, with the product positioned as a first-line therapy for biologics-naive patients [81][83] Question: Will there be more detailed safety data for EVA-one? - Management confirmed that one-year follow-up data will be shared, with ongoing efforts to provide updates on safety and efficacy [80][82]

Financial Performance - Everest Medicines achieved a revenue of RMB 706.7 million for the year 2024, exceeding the target of RMB 700 million[11]. - Revenue increased significantly by RMB 580.7 million or 461% to RMB 706.7 million for the year ending December 31, 2024, compared to RMB 125.9 million for the year ended December 31, 2023, driven by strong sales growth of Yijia® and successful launch of Naifukang® in mainland China[23]. - As of December 31, 2024, the net loss narrowed to RMB 685.0 million from RMB 792.5 million in the previous year, attributed to strong product sales and improved operational efficiency[21]. - The company recorded a net loss of RMB 1,041.4 million for the year ended December 31, 2024, compared to RMB 844.5 million for the year ended December 31, 2023[77]. - The adjusted loss for the year narrowed from RMB 713.6 million for the year ended December 31, 2023, to RMB 537.6 million for the year ending December 31, 2024, primarily due to the exclusion of one-time and non-recurring losses related to intangible asset impairment and non-cash expenses[22]. Product Development and Approvals - The innovative drug, NaimuKang®, was successfully included in the 2024 National Reimbursement Drug List, enhancing affordability for approximately 5 million patients with IgA nephropathy in China[10]. - In May 2024, NaimuKang® was approved for market launch in mainland China, marking a significant breakthrough in the treatment of IgA nephropathy[11]. - NaimuKang® also received new drug approvals in Singapore, Hong Kong, Taiwan, and South Korea in 2024, indicating substantial progress in the company's strategic layout in the Asian market[11]. - The clinical trial for EVER001, a covalent reversible BTK inhibitor, has shown positive results in treating primary membranous nephropathy, with approximately 2 million patients in China and 80,000 in Europe[14][16]. - Nefecon® received approval from the Hong Kong Department of Health for treating adult patients with primary IgA nephropathy at risk of disease progression, marking the fourth region to approve the drug after Macau, mainland China, and Singapore[27]. Market Strategy and Positioning - The company continues to deepen its dual-driven growth strategy, focusing on strengthening its commercialization operations and advancing its global product pipeline[11]. - The company is well-positioned in the nephrology treatment sector, further solidifying its leadership status in the market[11]. - The company plans to leverage the unique position of Naimu Kang® as the only IgA nephropathy treatment in the national medical insurance catalog, expecting significant sales growth and improved patient adherence[15]. - The company aims to enhance its global influence in biopharmaceuticals through strategic collaborations for EVER001, which has orphan drug status in the US and EU, indicating higher pricing potential[16]. - The company is actively exploring market expansion into other Asian regions, including Taiwan and South Korea, to benefit more IgA nephropathy patients[66]. Operational Efficiency - Everest Medicines' operational efficiency was highlighted by its ability to exceed revenue targets, demonstrating the effectiveness of its dual-driven strategy[11]. - Total operating expenses (including general and administrative, R&D, and distribution and selling expenses) as a percentage of revenue decreased by 561.8 percentage points, indicating improved operational efficiency[23]. - Operating expenses as a percentage of sales decreased by 561.8 basis points, indicating improved operational efficiency[76]. - Research and development expenses for the year ending December 31, 2024, were RMB 528.0 million, slightly down from RMB 540.1 million for the year ended December 31, 2023, reflecting continued strategic investment in various product lines[23]. Clinical Trials and Research - The mRNA product pipeline includes the personalized tumor vaccine EVM16, which is set to begin clinical trials in August 2024, with the first patient treated in March 2025[15][17]. - The company plans to announce the one-year follow-up data for the Phase 1b/2a clinical trial in 2025[33]. - The clinical trial data for EVER001 capsules showed that 81.8% of patients in the low-dose group achieved clinical remission after 36 weeks of treatment[32]. - EVER001 demonstrated good overall safety and tolerability, with no clinically significant adverse events observed that are typically associated with irreversible BTK inhibitors[32]. - The Phase III clinical study of Etrasimod for ulcerative colitis showed significant clinical and statistical improvements, with treatment differences in clinical remission rates reaching 20.4%[39]. Financial Position and Cash Flow - Cash and cash equivalents, along with bank deposits, totaled RMB 1,603.3 million as of December 31, 2024[21]. - The net cash generated from investing activities for the year ended December 31, 2024, was RMB 974.4 million, primarily due to net cash inflow from the sale of bank deposits of RMB 1,178.5 million[100]. - The company faced foreign exchange risk due to certain borrowings and trade payables denominated in non-functional currencies, but had no significant foreign currency risk apart from foreign currency-denominated borrowings as of December 31, 2024[111]. - The current ratio was 2.54, down from 7.63 as of December 31, 2023, indicating a decrease in liquidity[104]. - The company had no pledged assets as of December 31, 2024, as the previously pledged land for the Jiaxing manufacturing facility has been released[109]. Employee and Governance - As of December 31, 2024, the total number of employees in the group is 665, an increase from 432 in 2023, with 98.6% of sales coming from the largest customer[128][133]. - The total compensation cost for the group for the year ending December 31, 2024, is RMB 586.6 million, up from RMB 474.9 million in 2023[131]. - The group has no significant disputes with customers or suppliers as of December 31, 2024[134]. - The company has established service contracts with all executive directors for an initial period of three years, automatically renewing every three years thereafter[153]. - The company has no management contracts for the majority of its business operations as of December 31, 2024[158].

证券时报网讯，港股通标的中，云顶新耀-B以13.43%的跌幅领跌，紧随其后的是永达汽车，其股价下 跌了10.00%。 此外，融创中国、JS环球生活和绿景中国地产的股价也出现了较大幅度的下跌，跌幅分别为8.15%、 8.14%和7.89%。思摩尔国际和友宝在线的跌幅也较为显著，分别为7.50%和7.51%。 九方智投控股、汽车街、速腾聚创跌近7%，九毛九、再鼎医药、瑞尔集团、中广核矿业、创梦天地等 跌逾6%。 校对：王朝全 ...

Investment Rating - The report assigns a "Buy" rating to the company with a target price of HKD 56.20, indicating a potential upside of 21.1% from the current price of HKD 46.40 [1][11]. Core Insights - The successful inclusion of the drug "耐赋康" (EVER001) in the national medical insurance directory is expected to drive significant sales growth, with projected sales reaching RMB 12.2 billion and RMB 18.3 billion for 2025 and 2026, respectively [2]. - The report highlights the promising clinical results of EVER001, a reversible BTK inhibitor, which has shown high rates of clinical remission in patients with membranous nephropathy, a condition with increasing prevalence [1][2]. - The market potential for EVER001 is substantial, as it is the only drug approved for the IgA nephropathy indication in the national medical insurance directory, providing a significant first-mover advantage [2]. Financial Projections - Revenue projections for the company have been revised upwards, with expected revenues of RMB 744 million for 2024, RMB 1.765 billion for 2025, and RMB 2.951 billion for 2026, reflecting increases of 17.4% and 15.3% for the latter two years compared to previous forecasts [3][13]. - The net profit forecast for 2026 has been adjusted to RMB 409 million, a significant improvement from previous estimates [3][13]. - The gross profit margin is expected to improve to 79.0% by 2026, indicating enhanced operational efficiency [3][13]. Market Context - The report notes that the incidence of membranous nephropathy is rising, with approximately 2 million patients in China and significant numbers in the US, Europe, and Japan, highlighting the growing market opportunity for the company's products [1][2]. - The company is positioned in the biotechnology sector, which is experiencing robust growth, particularly in the development of innovative therapies for unmet medical needs [11].

Investment Rating - The report gives a "Buy" rating for the company with a target price of HKD 51.46 [6] Core Views - The company is focused on nephrology and anti-infective fields, with differentiated products entering the commercialization phase [2] - Nefecon (Nefucon) is expected to enter the 2024 national medical insurance catalog, with strong potential for volume growth through price reduction [3] - The company has a fully integrated mRNA platform and is expanding its mRNA product pipeline [16] - The company's products address unmet medical needs in IgA nephropathy and multi-drug resistant infections, with significant clinical and commercial potential [3][4] Financial Data and Valuation - The company's revenue is expected to grow significantly, with projected revenues of RMB 7.0 billion, RMB 15.6 billion, and RMB 25.6 billion for 2024, 2025, and 2026, respectively [5] - The net profit attributable to the parent company is expected to be RMB -979 million, RMB -320 million, and RMB 171 million for 2024, 2025, and 2026, respectively [5] - The DCF valuation suggests a fair value of HKD 51.46 per share, with a fair market value of HKD 16.8 billion [5] Product Pipeline and Commercialization - Nefecon (Nefucon) is the first drug globally approved for the treatment of IgA nephropathy, with significant clinical value and potential to become a foundational treatment [3][18] - Eravacycline (Yijia) has shown strong efficacy in treating multi-drug resistant infections, with rapid commercialization and revenue growth [4] - Etrasimod (Yiqu Mod) has the potential to become a first-line treatment for moderate to severe ulcerative colitis in China, with NDA submission expected in 2024 [2][104] Market Potential and Competitive Landscape - The prevalence of IgA nephropathy in China is 1.5-2 times higher than in Europe and 3-6 times higher than in the US, with a large and growing patient base [3][38] - The company has a competitive advantage in the multi-drug resistant infection market, with complementary products addressing unmet clinical needs [4][96] - The company's mRNA platform and pipeline have the potential to drive long-term growth, with a focus on oncology and autoimmune diseases [16][33] Strategic Focus and Future Outlook - The company is transitioning from a licensing model to a dual-driven model of strong R&D and commercialization capabilities [16] - The company is strategically focused on nephrology and anti-infective fields, with a pipeline that could address the needs of approximately 10 million patients with glomerular diseases [77] - The company's products are expected to achieve peak annual sales of RMB 10 billion, driven by the commercialization of four core products [29][30]

Commercialization and Product Development - In the first half of 2024, Everest Medicines achieved a significant milestone with the successful commercialization of NEFECON® as the first disease-modifying treatment for IgA nephropathy in China, which is expected to reduce kidney function decline by 50%[7] - NEFECON® received approval from the National Medical Products Administration in China in November 2023 and was commercialized in May 2024, marking a key achievement for the company[8] - In March 2024, NEFECON® was approved by the Singapore Health Sciences Authority for treating adult patients at risk of disease progression, further expanding patient accessibility in Asia[8] - The FDA granted NEFECON® a seven-year exclusivity period for its new indication, extending until December 2030, enhancing its market position in the U.S.[8] - The company is focused on expanding its clinical applications of IGA® in more hospitals, driving continuous revenue growth[7] - Everest Medicines is actively seeking collaborations in key therapeutic areas such as renal, infectious, and autoimmune diseases to maximize synergies across its clinical and commercialization platforms[7] - The company has established a comprehensive biopharmaceutical platform covering early research, clinical development, registration, production, and commercialization[7] - The product pipeline includes innovative drugs targeting kidney diseases, anti-infectives, and autoimmune diseases, with significant revenue growth expected from these assets[25] - The company plans to submit a new drug application for Iqmod in China in 2024, following the announcement of top-line results from the Phase 3 clinical trial in July[28] - The company aims to launch the first commercially valuable IgA nephropathy testing reagent, providing effective tools for diagnosis and monitoring[21] Financial Performance - Revenue increased from RMB 89 million for the six months ended June 30, 2023, to RMB 301.5 million for the six months ending June 30, 2024, primarily due to the continued sales expansion of Yijia® in mainland China and Hong Kong, and the launch of Naifukang® in mainland China and Singapore[22] - Gross margin rose from 62.7% for the six months ended June 30, 2023, to 76.6% for the six months ending June 30, 2024, driven mainly by the launch of new products[22] - Net loss increased from RMB 423.6 million for the six months ended June 30, 2023, to RMB 632.4 million for the six months ending June 30, 2024, primarily due to a one-time impairment loss related to mRNA COVID-19 vaccine intangible assets[22] - Adjusted net loss decreased from RMB 326.9 million for the six months ended June 30, 2023, to RMB 212.6 million for the six months ending June 30, 2024[23] - The company aims to achieve revenue guidance of RMB 700 million for the current year, reflecting confidence in meeting the clinical needs of patients in Asia[24] - The company reported revenue of RMB 301.5 million for the six months ended June 30, 2024, compared to RMB 8.9 million for the same period in 2023, marking a significant increase[35] - The company recorded an operating loss of RMB 671.8 million for the six months ended June 30, 2024, compared to RMB 478.9 million in the same period of 2023, mainly due to impairment losses related to mRNA COVID-19 vaccine intangible assets[44] Research and Development - R&D expenses decreased from RMB 288.5 million for the six months ended June 30, 2023, to RMB 253.2 million for the six months ending June 30, 2024, mainly due to reduced clinical trial costs[22] - The company is developing four mRNA therapeutic cancer vaccine projects after terminating its collaboration with Providence Therapeutics, focusing on proprietary mRNA technology[19] - A personalized tumor vaccine clinical trial (EVM16CX01) has been initiated to evaluate the safety and preliminary efficacy of EVM16 in advanced or recurrent solid tumors[20] - The global Phase 2b PALIZADE trial for zetomipzomib in treating active lupus nephritis has commenced with the first patient dosed in China[12] - EVER001, a new generation BTK inhibitor, is in clinical development for treating membranous nephropathy, with top-line results expected in the second half of 2024[13] Collaborations and Partnerships - Calliditas announced positive results from the NefigArd Phase III study, showing significant eGFR benefits over a 2-year period with 9 months of treatment[9] - The Chinese National Medical Products Administration has accepted the supplemental application for NefigArd, which could lead to it being the first approved IgA nephropathy treatment in China[11] - Calliditas expects to announce top-line results from the open-label study of NefigArd in China in the second half of 2024[11] - The company has initiated collaborations to establish an integrated ecosystem for kidney disease diagnosis and treatment, aiming to launch a commercially viable IgA nephropathy testing reagent[29] - The company has ongoing collaborations and licensing agreements with Arena Pharmaceuticals and United Therapeutics for the development and commercialization of proprietary products in various regions, with upfront payments totaling RMB 78.4 million[168] Employee and Operational Metrics - As of June 30, 2024, the total employee count is 520, an increase from 395 as of June 30, 2023, with 506 based in China[62] - Total compensation expenses for the six months ended June 30, 2024, amounted to RMB 281.3 million, compared to RMB 248.2 million for the same period in 2023, reflecting an increase of approximately 13.4%[63] - The company has established an internal end-to-end capability to develop and manufacture mRNA therapeutic drugs, with a dedicated team of over 30 scientists in Shanghai[33] Shareholder and Equity Information - The company has a significant shareholder, Mr. Bo Wei, holding 39.75% of the shares[76] - As of June 30, 2024, the total number of issued shares is 325,164,793[83] - Major shareholder Vistra Trust (Singapore) Pte. Limited holds 39.75% of the shares, totaling 129,265,877 shares[80] - C-Bridge Capital GP, Ltd. and its affiliates collectively hold 16.23% of the shares, amounting to 52,777,778 shares each[80] - The company has four existing share plans, including pre-IPO management and employee stock option plans, with a total of 10,572,800 new shares representing approximately 3.26% of the weighted average shares during the reporting period[84] Financial Position and Cash Flow - Cash and cash equivalents and time deposits amounted to RMB 1,925.5 million as of June 30, 2024[23] - Cash and cash equivalents plus bank deposits decreased from RMB 2,349.7 million as of December 31, 2023, to RMB 1,925.5 million as of June 30, 2024, primarily due to cash used in operating activities[52] - Net cash used in operating activities was RMB 414.9 million for the six months ended June 30, 2024, compared to RMB 441.4 million for the same period in 2023[53] - Net cash generated from investing activities was RMB 447.7 million for the six months ended June 30, 2024, compared to RMB 894.4 million for the same period in 2023[54] - Net cash generated from financing activities was RMB 15.6 million for the six months ended June 30, 2024, compared to cash used of RMB 208.3 million for the same period in 2023[55] Impairment and Asset Management - The company recognized a full impairment loss of RMB 356.3 million (equivalent to $50 million) on intangible assets related to the mRNA COVID-19 vaccine due to declining economic and social benefits from continued development[188] - The company incurred a total of RMB 21,404 thousand in administrative and selling expenses in the first half of 2024, compared to RMB 2,386 thousand in the same period of 2023, representing a significant increase[166] - The company has not identified any impairment indicators for intangible assets, except for the mRNA COVID-19 vaccine, as of June 30, 2024[192] Regulatory and Compliance - The audit committee, consisting of three independent non-executive directors, has reviewed the unaudited interim results for the six months ended June 30, 2024[67] - The company’s financial statements have been reviewed in accordance with international standards, ensuring compliance with relevant regulations[102] - The company has complied with the new Chapter 17 of the Listing Rules effective from January 1, 2023[84]

证券研究报告 | 公司动态点评 2024 年 09 月 04 日 云顶新耀-B（01952.HK） 商业化成绩亮眼，耐赋康收入超预期 | --- | --- | --- | --- | --- | --- | --- | --- | |--------------------------------------------|---------|-------------------------------------|---------|----------|----------|-------------------------------------------|----------| | 财务指标 | 2022A | 2023A | 2024E | 2025E | 2026E | 买入（维持评级） | | | 营业收入（百万元） | 12.79 | 125.93 | 702.70 | 1,749.72 | 2,817.06 | 股票信息 | | | 增长率 yoy （ % ） | | 23588.89 884.46 458.00 149.00 61.00 | | | | | | | 归母净利润（百万元） ...

Investment Rating - The report assigns a "Buy" rating to the company with a target price of HKD 44.00, indicating a potential upside of 110.0% from the current price of HKD 20.95 [6]. Core Insights - The company has exceeded sales expectations in 1H24, particularly for its products Yijia and Naifukang, leading to an upward revision of revenue forecasts for 2024-25 and an increase in the target price [1]. - The upcoming 18 months are expected to be rich in catalysts, including the commercialization of new drugs and ongoing clinical studies [1][2]. - The company has demonstrated an efficient commercialization model for Naifukang, achieving significant market penetration with a limited sales force [1]. Financial Performance Summary - 1H24 product sales surged by 158% to RMB 302 million, surpassing market expectations [1]. - Naifukang generated sales of RMB 167 million within a month and a half of its launch in mainland China, with further approvals anticipated [1]. - Yijia sales reached RMB 134 million, driven by positive real-world study results and deeper market coverage [1]. - Adjusted non-IFRS net loss narrowed to RMB 213 million in 1H24 from RMB 327 million in 1H23, with a gross margin of 83% [1]. - The company expects product sales revenue of RMB 700 million in 2024 and aims for cash flow breakeven in 2025 [1]. Revenue Forecast Changes - Revenue forecasts for 2024E and 2025E have been adjusted to RMB 744 million (up 5.5%) and RMB 1,504 million (up 0.8%), respectively [3]. - Gross profit estimates for 2024E and 2025E have been revised to RMB 573 million (up 8.3%) and RMB 1,173 million (up 2.1%) [3]. - The gross margin is projected to improve to 77.0% in 2024E and 78.0% in 2025E [3]. Key Upcoming Events - Important upcoming events include the results of the medical insurance negotiations for Naifukang, the submission of NDA for Yikumo in mainland China, and the anticipated launch of additional innovative drugs [2]. - Clinical data readouts for various ongoing studies are expected to provide further insights into the company's product pipeline [2].

Company Performance - In the first half of 2024, Everest Medicines achieved significant milestones, including the successful commercialization of the only approved treatment for IgA nephropathy in China, Nanfukang®[7]. - The company reported a strong performance despite the biotechnology sector facing challenges, outperforming the Hang Seng Hong Kong-listed biotech index, which fell nearly 30% in the same period[7]. - Revenue growth is driven by deepening hospital penetration and expanding clinical applications of its product Yijia® in more hospitals[7]. - The company remains committed to efficiently executing its strategy to deliver innovative therapies to more patients globally[7]. - Everest Medicines is confident in its development as a leading biopharmaceutical company in the Asia-Pacific region, supported by increasing policy backing and its robust performance[7]. Product Development and Approvals - NEFECON® is the first drug globally for the treatment of IgA nephropathy, showing a 50% reduction in kidney function decline and a 66% delay in kidney function deterioration in the Chinese population, extending the time to dialysis or kidney transplant by 12.8 years[8]. - NEFECON® received approval from the Chinese National Medical Products Administration in November 2023 and is expected to be commercially launched in mainland China in May 2024[8]. - The company plans to announce topline results from the open-label study of NEFECON® in China in the second half of 2024[11]. - Zetomipzomib, a novel selective immunoproteasome inhibitor, has shown good safety and tolerability in treating severe chronic autoimmune diseases, with clinical trials approved in China for lupus nephritis[11]. - The company plans to submit a new drug application for cefepime-tazobactam for complicated urinary tract infections in mainland China by 2025[16]. Financial Performance - Revenue increased from RMB 89 million for the six months ended June 30, 2023, to RMB 301.5 million for the six months ending June 30, 2024, primarily due to the expansion of sales in mainland China and Hong Kong[22]. - Gross margin improved from 62.7% for the six months ended June 30, 2023, to 76.6% for the six months ending June 30, 2024, driven by the launch of new products[22]. - Net loss increased from RMB 423.6 million for the six months ended June 30, 2023, to RMB 632.4 million for the six months ending June 30, 2024, primarily due to a one-time impairment loss related to mRNA COVID-19 vaccine intangible assets[22]. - The company aims to achieve revenue guidance of RMB 700 million for the current year, reflecting confidence in meeting the clinical needs of patients in Asia[24]. - The company reported a net loss of RMB 632,413 thousand for the six months ended June 30, 2024, compared to a loss of RMB 423,612 thousand for the same period in 2023[111]. Research and Development - The company is developing multiple mRNA therapeutic drugs and has established an end-to-end capability for mRNA drug development and manufacturing[33]. - The company has terminated its collaboration with Providence Therapeutics to focus on developing proprietary mRNA therapeutic vaccines, shifting its strategy towards owning all intellectual property and global rights[19]. - The company plans to submit a new drug application for Etrasimod in China in 2024, following the announcement of positive top-line results from a Phase 3 clinical trial in July[28]. - The company expects to announce the topline results of the Phase 1b clinical study for EVER001 in membranous nephropathy in the second half of 2024[13]. - The company has initiated a partnership to develop an integrated ecosystem for kidney disease diagnosis and treatment, aiming to launch a commercially valuable IgA nephropathy testing kit[29]. Market Strategy and Collaborations - The company is actively seeking external collaborations in key therapeutic areas such as renal, infectious, and autoimmune diseases to maximize synergies across its clinical and commercialization platforms[7]. - The commercialization team has expanded to support the launch of new products and growth in existing product sales, with selling expenses increasing from RMB 64.1 million to RMB 200.4 million[22]. - The sales team for NEFECON® has been established with over 100 representatives, targeting 400 to 600 core hospitals, covering more than 60% of the IgA nephropathy patient population in China[29]. - The company is collaborating with contract sales organizations to expand access to Etrasimod beyond its internal commercialization team, targeting additional patients[29]. - The company has published several articles in medical journals regarding Etrasimod's efficacy and safety in treating various infections, enhancing its clinical profile[30]. Governance and Compliance - The audit committee consists of three independent non-executive directors, ensuring compliance with corporate governance standards[67]. - The company has implemented training for directors regarding compliance with the standard code of conduct to prevent future violations[66]. - The company has established a special resolution to amend its articles of association to comply with updated listing rules[69]. - The company maintains a strong governance structure with significant shareholding by key stakeholders, ensuring alignment of interests[81]. - The company plans to continue compliance with the new Chapter 17 of the listing rules effective from January 1, 2023[84]. Shareholder Information - As of June 30, 2024, Mr. Bo Wei holds 129,265,877 shares, representing 39.75% of the company's equity[76]. - Major shareholders include Vistra Trust (Singapore) Pte. Limited and Nova Aqua Limited, both holding 129,265,877 shares (39.75%)[80]. - C-Bridge Healthcare Fund II, L.P. and its affiliates collectively hold 52,777,778 shares, accounting for 16.23% of the equity[80]. - The total number of shares issued as of June 30, 2024, is 325,164,793[78]. - The company has not disclosed any additional interests or short positions held by directors or senior management as of June 30, 2024[78].

Investment Rating - Buy (首次评级) [1] Core Views - The company's flagship product, Nefecon, has successfully commercialized, marking a significant milestone in the treatment of IgA nephropathy [1][2] - Revenue is expected to grow steadily as products like Eravacycline and Nefecon continue to contribute to sales, with potential for further expansion in 2024 [1][2] - The company is actively preparing for医保谈判, which could significantly boost Nefecon's revenue if successful [2] - The mRNA platform, focusing on tumor therapeutic vaccines, is expected to become a cornerstone for sustainable growth in the medium to long term [4] Financial Performance - Revenue for 2023 was RMB 125.93 million, a significant increase from RMB 12.79 million in 2022, driven by the commercialization of Eravacycline and Nefecon [1] - Net loss for 2023 widened to RMB 844.46 million, compared to RMB 247.28 million in 2022, primarily due to increased expenses and the absence of a one-time gain from the Trodelvy® transaction [1] - Revenue is projected to grow to RMB 702.70 million in 2024, RMB 1,749.72 million in 2025, and RMB 2,817.06 million in 2026 [1] Product Pipeline - **Nephrology**: Nefecon, the first innovative drug for IgA nephropathy, has shown significant clinical benefits in reducing proteinuria and slowing eGFR decline [2][38] - **Infectious Diseases**: Eravacycline, a broad-spectrum antibiotic, has been successfully commercialized, while Cefepime-Taniborbactam is expected to launch by 2025-2026 [2][53] - **Autoimmune Diseases**: Etrasimod, approved in Macau, is expected to contribute to revenue starting in 2024-2025 [2] - **mRNA Platform**: The company is focusing on developing tumor therapeutic vaccines, with clinical trials expected to begin in the second half of 2024 [4] Market Potential - The global market for chronic kidney disease (CKD) is substantial, with an estimated 700 million patients worldwide, and China accounts for approximately 18% of this population [28][30] - IgA nephropathy, the most common primary glomerular disease, has a higher prevalence in Asian populations, particularly in China, where it accounts for about 53% of primary glomerular diseases [31][32] - The market for multi-drug resistant Gram-negative bacteria (MDR-GNB) antibiotics is expected to grow, with projections indicating a market size of RMB 19.3 billion by 2027 [59] Strategic Developments - The company has built a robust commercialization team to accelerate the market penetration of its products in Greater China and other Asia-Pacific markets [1][19] - The company is leveraging the "Greater Bay Area Drug and Device Access" policy to expand the reach of its products, such as Etrasimod, in the region [2] - The mRNA platform is being developed with full industrial chain capabilities, positioning the company for long-term growth in the oncology space [4]