Financial Performance - Everest Medicines reported a revenue of RMB 125.9 million from the launch of its first product, IGA, in China, exceeding initial expectations of RMB 70 million to RMB 100 million[7]. - Revenue increased by RMB 113.1 million or 884% to RMB 125.9 million for the year ended December 31, 2023, primarily due to the commercialization of Yijia® in mainland China and Hong Kong, and the launch of Naifukang® in Macau[11]. - The company achieved revenue of RMB 125.9 million in 2023, significantly exceeding the initial guidance of RMB 70 million to RMB 100 million[36]. - The combined revenue from Yijia® and Naifukang® is expected to reach RMB 700 million in 2024, with a goal of achieving cash flow break-even by the end of 2025[38]. - The company reported a loss of RMB 844.5 million for the year ended December 31, 2023, compared to a loss of RMB 247.3 million in 2022[41]. - The net loss attributable to equity holders increased from RMB 247.3 million in 2022 to RMB 844.5 million in 2023, a rise of about 241.5%[55]. - The company aims to achieve cash breakeven by 2025, focusing on high-value therapeutic areas such as kidney diseases, anti-infection, and autoimmune diseases[10]. Product Development and Commercialization - The company achieved a significant milestone with the approval of the New Drug Application (NDA) for its IgA nephropathy treatment, Nanfangkang, in Macau and mainland China[7]. - Everest Medicines plans to commercialize Nanfangkang in mainland China in the first half of 2024, with a sales team expected to reach 120 representatives by the end of the year[7]. - The company has established a commercialization team for its products, marking 2023 as the year of commercialization in China[7]. - The company plans to commercialize the key nephrology product Naifuliao in mainland China in 2024, with over 120 new employees to promote the product[9]. - The company is advancing the global Phase 2b PALIZADE clinical study for zetomipzomib in collaboration with Kezar Life Sciences, targeting autoimmune diseases including lupus nephritis[8]. - The company has established a strong product pipeline across nephrology, anti-infection, and autoimmune diseases, expected to drive significant revenue growth[32]. - The company plans to submit new drug applications for Cefepime-taniborbactam and Etrasimod in China in 2024[35]. Research and Development - R&D expenses decreased by RMB 269.6 million to RMB 540.1 million for the year ended December 31, 2023, mainly due to several candidate drugs completing clinical trials and entering registration or commercialization stages[11]. - The company has established a new R&D team focused on mRNA platform development, with plans to enter clinical trials for self-developed projects in 2024[9]. - The company is leveraging its clinically validated mRNA platform to advance therapeutic vaccines for cancer, with plans to enter clinical trials in 2024[14]. - The company successfully completed the technical transfer of its mRNA platform and expects its first self-developed tumor therapeutic vaccine to enter clinical trials in 2024[40]. Regulatory Approvals and Clinical Trials - Everest Medicines is also seeking regulatory approval for Nanfangkang in South Korea and Taiwan[7]. - The company has received FDA approval for Velsipity® for the treatment of moderate to severe active ulcerative colitis in adults, with plans to submit a new drug application in Macau and China[8]. - TARPEYO® received approval in November 2023 for the treatment of primary IgA nephropathy in China, with plans for market launch in 2024[15]. - The company initiated a clinical application of TARPEYO® in April 2023, allowing approximately 700 patients to benefit from innovative therapies for IgA nephropathy[16]. - The company completed patient recruitment for the open-label extension study of TARPEYO® in August 2023, aimed at evaluating its efficacy and safety in Chinese patients after completing phase 3 clinical trials[16]. Market Strategy and Expansion - The company aims to cover 600 core hospitals, targeting at least 60% of the market potential for Nanfangkang[7]. - A commercial team of over 100 sales personnel has been established in mainland China, successfully covering over 300 top-tier hospitals for IGA® promotion, with plans to form an additional sales team of approximately 120 people for TARPEYO® in 600 core hospitals[14]. - The company is preparing to launch Etrasimod to approximately 5 million IgA nephropathy patients in mainland China in 2024[36]. - By March 2024, Nefecon is expected to be commercialized in mainland China, Hong Kong, and Singapore, further increasing patient accessibility in Asia[21]. Corporate Governance and Management - The board consists of three executive directors, two non-executive directors, and three independent non-executive directors[157]. - The company has established a robust corporate governance framework to guide management in achieving its operational goals[168]. - The company has adopted the corporate governance code as a benchmark for its governance practices, emphasizing the importance of high standards in protecting shareholder interests and enhancing company value[170]. - The company has established mechanisms to ensure independent viewpoints are communicated effectively within the board[181]. Financial Position and Cash Flow - As of December 31, 2023, cash and cash equivalents amounted to RMB 2,349.7 million[12]. - The current ratio as of December 31, 2023, was 8.36, an increase from 3.92 in the previous year[63]. - Cash and cash equivalents increased from RMB 1,651.4 million in 2022 to RMB 2,349.7 million in 2023, an increase of approximately 42.3%[61]. - The net cash used in operating activities was RMB 769.2 million, compared to a net loss of RMB 844.5 million during the same period[62]. Employee and Shareholder Information - The total number of employees in the company was 432, an increase from 365 in 2022[80]. - The total compensation cost for the company for the year ended December 31, 2023, was RMB 474.9 million, down from RMB 853.1 million for the year ended December 31, 2022[82]. - The company has a significant number of shares held by controlled corporations, indicating a concentrated ownership structure[101]. - The company aims to recruit and retain key employees through its pre-IPO management stock option plan[105]. Social Responsibility and Community Engagement - The company made charitable donations of approximately RMB 15.8 million for the year ended December 31, 2023, compared to zero in 2022[87]. - The company emphasizes the importance of gender diversity at all levels and aims to maintain a balanced board composition[196].

Stock Performance - In the first half of 2023, Everest Medicines' stock price increased by 37%, outperforming the Hang Seng Hong Kong-listed biotech index and the Hang Seng Index, which fell by 23.41% and 4.3% respectively[10]. Product Launches and Approvals - The company launched its first product, Eiger, in July 2023 for the treatment of complex intra-abdominal infections in adult patients[10]. - Everest Medicines has three additional candidate drugs expected to receive NDA approval or submission in 2023 and 2024, including Nefecon for IgAN, with anticipated NDA approval later this year in China and Singapore[10]. - The company plans to submit NDA applications for a novel antibiotic and a treatment for ulcerative colitis in the near term[10]. - The Singapore Health Sciences Authority accepted the NDA for Nefegrastim for treating adult patients with lgAN at risk of disease progression, with approval expected in 2023[12]. - The company expects to receive NDA approvals for Nefegrastim in mainland China and Singapore in 2023, and plans to submit NDAs in South Korea, Hong Kong, Macau, and Taiwan[14]. - The company announced the successful launch of Icaris in China, marking its first commercial product in the region[15]. - The FDA accepted the NDA for a potential treatment for complex urinary tract infections, with a target action date of February 22, 2024[16]. - Etrasimod is under evaluation for moderate to severe active UC, with a decision from the FDA expected in the second half of 2023[18]. Financial Performance - Revenue increased from RMB 1.0 million for the six months ended June 30, 2022, to RMB 8.9 million for the six months ended June 30, 2023, primarily due to sales of IGA® in Singapore and Trodelvy® during the transition period with Gilead Sciences[20]. - Net loss decreased from RMB 668.0 million for the six months ended June 30, 2022, to RMB 423.6 million for the six months ended June 30, 2023, mainly due to multiple candidate drugs completing clinical trials and organizational restructuring[20]. - Adjusted net loss decreased from RMB 523.7 million for the six months ended June 30, 2022, to RMB 326.9 million for the six months ended June 30, 2023, primarily due to the reduction in IFRS losses[21]. - The company recorded a loss of RMB 423.6 million for the six months ended June 30, 2023, compared to a loss of RMB 668.0 million for the same period in 2022[29]. - The company reported a total of 73,079,000 shares issued during its global offering, including those from the exercise of the over-allotment option[64]. - The company reported a comprehensive loss for the six months ended June 30, 2023, with financial data presented in thousands of RMB[98]. Research and Development - The company is focused on expanding its product portfolio through acquisitions and in-house development of innovative therapies[10]. - The company is transitioning from a clinical-stage biotech firm to a commercial-stage biopharmaceutical company, enhancing its capabilities in drug discovery, clinical development, manufacturing, and commercialization[10]. - The company has established a strong product pipeline, including potential first-in-class or best-in-class therapeutics and mRNA vaccines, covering short-term, medium-term, and long-term opportunities[23]. - The company is focused on expanding its product pipeline through self-research teams and clinically validated mRNA platforms for infectious diseases and oncology projects[22]. Cost Management - R&D expenses decreased from RMB 345.5 million for the six months ended June 30, 2022, to RMB 288.5 million for the six months ended June 30, 2023, mainly due to multiple candidate drugs completing clinical trials and entering registration or commercialization stages[20]. - General and administrative expenses reduced from RMB 118.9 million for the six months ended June 30, 2022, to RMB 83.1 million for the six months ended June 30, 2023, attributed to organizational restructuring and a decrease in share-based compensation expenses[20]. - Selling and distribution expenses fell from RMB 148.2 million for the six months ended June 30, 2022, to RMB 64.1 million for the six months ended June 30, 2023, primarily due to the transfer of Trodelvy® commercialization activities to Gilead and organizational optimization[20]. Cash and Liquidity - Cash and cash equivalents, along with time deposits, amounted to RMB 2,540.2 million as of June 30, 2023[20]. - Cash and cash equivalents increased from RMB 1,651.4 million as of December 31, 2022, to RMB 2,540.2 million as of June 30, 2023, an increase of about 53.8%[45]. - The company's current assets totaled RMB 2,651.8 million as of June 30, 2023, including cash and cash equivalents of RMB 2,540.2 million[45]. Employee and Organizational Changes - The company established a commercial team of 138 members focused on key treatment areas, including anti-infection and nephrology, as of June 30, 2023[24]. - Employee benefits expenses decreased from RMB 182.145 million in 2022 to RMB 111.719 million in 2023, a reduction of approximately 38.7%[31]. - The company employed a total of 395 employees as of June 30, 2023, down from 476 employees a year earlier[56]. Partnerships and Collaborations - The company is actively seeking commercial partnerships in the fields of kidney disease and autoimmune diseases to expand its pipeline and ecosystem[26]. - The company has formed partnerships with leading pharmaceutical supply chain service providers in China to accelerate the commercialization of Yijia®[24]. Licensing and Acquisitions - The company recognized an impairment loss of $7.5 million (equivalent to RMB 52.0 million) related to the termination of the licensing agreement with United Therapeutics, effective August 28, 2023[153]. - The company made upfront payments totaling $7 million (equivalent to RMB 46.4 million) to Tetraphase Pharmaceuticals for the exclusive licensing agreement for Eravacycline[154]. - The company has agreed to make milestone payments of $8 million (equivalent to RMB 55.4 million) following the approval of Eravacycline's new drug application in China[154]. Financial Liabilities and Assets - Total liabilities decreased significantly to RMB 477,370,000 from RMB 960,255,000, indicating a stronger balance sheet[100]. - The total financial liabilities as of June 30, 2023, were RMB 445,333 thousand, a decrease from RMB 937,526 thousand as of December 31, 2022[122]. - The company’s total assets as of June 30, 2023, were RMB 2,656,428 thousand, down from RMB 3,412,655 thousand at the end of 2022, representing a decrease of 22.1%[181].

Financial Performance - Everest Medicines' stock price increased by 37% in the first half of 2023, outperforming the Hang Seng Hong Kong-listed biotech index and the Hang Seng Index, which fell by 23.41% and 4.3% respectively[10]. - Revenue increased from RMB 1.0 million for the six months ended June 30, 2022, to RMB 8.9 million for the six months ended June 30, 2023, primarily due to sales of the product Yiga in Singapore and sales of Trodelvy® during the transition period with Gilead Sciences[20]. - The company recorded a loss of RMB 423.6 million for the six months ended June 30, 2023, compared to a loss of RMB 668.0 million for the same period in 2022[29]. - Adjusted loss decreased from RMB 523.7 million for the six months ended June 30, 2022, to RMB 326.9 million for the six months ended June 30, 2023, primarily due to the reduction in IFRS losses[21]. - The company reported a comprehensive loss for the six months ended June 30, 2023, with financial data presented in thousands of RMB[98]. - The basic loss per share attributable to shareholders was RMB (1.40), an improvement from RMB (2.26) in the previous year[99]. - Operating loss narrowed from RMB 639.7 million in the first half of 2022 to RMB 478.9 million in the first half of 2023, a reduction of approximately 25.1%[36]. - The company reported a significant increase in cash and cash equivalents, with a total of RMB 2,540,167 thousand as of June 30, 2023, compared to RMB 1,651,376 thousand at the end of 2022, marking a growth of 53.8%[186]. Product Development and Pipeline - The company transitioned from a clinical-stage biotech firm to a commercial-stage company, launching its first product, Eiger, in July 2023 for treating complex intra-abdominal infections[10]. - Three additional candidate drugs are expected to receive NDA approval or submission in 2023 and 2024, including the kidney disease treatment, Neficor, which is anticipated to gain NDA approval later this year in China and Singapore[10]. - The company plans to submit NDA applications for a novel antibiotic, Cefepime-Tazobactam, and Etrasimod for ulcerative colitis in the near term[10]. - Everest Medicines is expanding its product portfolio through acquisitions and in-house development, focusing on innovative and differentiated therapies[10]. - The company is developing the bivalent COVID-19 booster candidate vaccine EVER-COVID19-M1.2 targeting the Omicron variant, with an IND application submitted in China[19]. - The product pipeline includes potential first-in-class or best-in-class therapies and vaccines, with ongoing research in infectious diseases and oncology using a clinically validated mRNA platform[22]. - The company aims to provide long-term value to shareholders and patients by expanding its product pipeline and entering commercialization phases for various products[22]. Research and Development - R&D expenses decreased from RMB 345.5 million for the six months ended June 30, 2022, to RMB 288.5 million for the six months ended June 30, 2023, mainly due to multiple candidates completing clinical trials and entering registration or commercialization stages[20]. - The company established a commercial team of 138 members focused on key treatment areas, including anti-infection and nephrology, as of June 30, 2023[24]. - Clinical trial and research expenses decreased from RMB 141.971 million in 2022 to RMB 129.876 million in 2023, a decrease of about 8.5%[31]. - The company continues to invest in research and development, with ongoing projects aimed at enhancing its product offerings and market position[151]. Financial Management and Expenses - General and administrative expenses reduced from RMB 118.9 million for the six months ended June 30, 2022, to RMB 83.1 million for the six months ended June 30, 2023, attributed to organizational optimization and a decrease in related share-based compensation expenses[20]. - Sales and marketing expenses decreased from RMB 148.2 million for the six months ended June 30, 2022, to RMB 64.1 million for the six months ended June 30, 2023, primarily due to the transfer of Trodelvy® commercialization activities to Gilead and organizational optimization[20]. - Employee benefits expenses decreased from RMB 182.145 million in 2022 to RMB 111.719 million in 2023, a reduction of approximately 38.7%[31]. - The total cost of revenue, general and administrative expenses, research and development expenses, and distribution and selling expenses amounted to RMB 480,059 thousand in the first half of 2023, compared to RMB 612,945 thousand in 2022, showing a reduction of approximately 21.6%[129]. Regulatory Approvals and Clinical Trials - Nefecon received global innovative product fast track review designation from MFDS for treating primary IgAN, expected to accelerate regulatory review time by 25%[11]. - NDA for Nefecon accepted in Singapore for adults at risk of disease progression, with approval expected in 2023[12]. - sNDA submitted to FDA for TARPEYO based on complete data from NeflgArd Phase 3 trial, with a PDUFA target date of December 20, 2023[13]. - Etrasimod's NDA for moderate to severe active UC is under review by FDA, with a decision expected in the second half of 2023[18]. - Etrasimod Phase 3 trial patient recruitment completed in Asia for treating moderate to severe active UC[17]. - Igarasin approved in China for treating adult patients with cIAI, marking the company's first commercial product in the region[15]. - The company plans to submit NDA for Igarasin in Taiwan in 2023[15]. - The company anticipates NDA approvals for Nefecon in mainland China and Singapore in 2023[14]. Shareholder and Equity Information - As of June 30, 2023, Mr. Bo Wei held 42.24% of the company's shares, totaling 133,526,552 shares[69]. - The total number of issued shares is 316,084,572[76]. - The company has established four share plans, including pre-IPO management and employee stock option plans, and post-IPO stock option and incentive plans[77]. - The company has granted unexercised stock options totaling 3,657,511 shares to 105 participants, including directors and senior management[81]. - The company has 11,204,645 shares available for grant under the post-IPO share option plan as of August 30, 2023, following the approval of an additional 4,700,000 share options by independent shareholders[88]. Investments and Acquisitions - The company recognized an impairment loss of $7.5 million (equivalent to RMB 52.0 million) related to intangible assets due to the termination of the licensing agreement with United Therapeutics, effective August 28, 2023[153]. - The company made upfront payments totaling $7 million (equivalent to RMB 46.4 million) to Tetraphase Pharmaceuticals for the exclusive licensing agreement for Eravacycline[154]. - The company has agreed to make milestone payments of $8 million (equivalent to RMB 55.4 million) following the approval of Eravacycline's new drug application by Chinese regulatory authorities in March 2023[154]. - The total upfront fees for the exclusive global licensing agreement with Novartis for FGF401 amounted to $20 million (equivalent to RMB 132.7 million) plus the issuance of 4 million shares of convertible preferred stock[157]. - The company paid a total of $5 million (equivalent to RMB 33.2 million) as an upfront cash payment to Venatorx for the exclusive licensing agreement for Taniborbactam[159].

Financial Performance - Revenue increased from RMB 54 million in 2021 to RMB 12.8 million in 2022, primarily due to sales of Xerava and Trodelvy® in Singapore[13]. - The net loss for the year ended December 31, 2022, was RMB 247.3 million, a significant reduction from RMB 1,008.7 million in 2021, largely due to other income from the Trodelvy® transaction[13]. - Adjusted loss for the year ended December 31, 2022, was RMB 17.4 million, a decrease from RMB 777.3 million in 2021, reflecting improved financial performance[14]. - The company reported a loss of RMB 247.3 million for the year ended December 31, 2022, compared to a loss of RMB 1,008.7 million for the year ended December 31, 2021, primarily due to gains from the sale of Trodelvy®[43][56]. - Revenue for the year ended December 31, 2022, was RMB 12.8 million, generated from the sales of Ilaris and Trodelvy® in Singapore[44]. - Research and development expenses increased from RMB 613.4 million in 2021 to RMB 809.7 million in 2022, attributed to an increase in clinical trial numbers and expansion of the internal drug discovery team[43][44]. - Distribution and selling expenses rose from RMB 198.2 million in 2021 to RMB 326.7 million in 2022, mainly due to increased employee benefits and pre-commercialization activities[46]. - General and administrative expenses increased from RMB 242.7 million in 2021 to RMB 276.5 million in 2022, primarily due to higher professional service fees[47]. - Other net income surged to RMB 1,143.4 million in 2022 from RMB 22.9 million in 2021, primarily due to proceeds from the sale of Trodelvy®[50]. - Operating loss decreased from RMB 1,026.3 million in 2021 to RMB 256.8 million in 2022, mainly due to gains from the Trodelvy® transaction[51]. Strategic Direction and Growth - Everest Medicines' stock increased over 300% from a low of HKD 6.18 on October 31, 2022, to January 31, 2023, following the announcement of a new strategic direction[7]. - The company returned the rights to Trodelvy to Gilead Sciences to improve its balance sheet, focusing on key therapeutic areas with strong market potential[7]. - The new CEO, Mr. Luo Yongqing, appointed in September 2022, is expected to lead the company into a new phase of growth in commercial and clinical operations[7]. - The company aims to leverage its clinically validated mRNA technology platform to advance projects in its key therapeutic areas[7]. - Everest Medicines is seeking promising business development opportunities to acquire global rights to assets while enhancing its internal drug discovery team[7]. - The company has streamlined operations to improve organizational efficiency and adapt to external macroeconomic conditions[7]. - The company is committed to becoming a comprehensive biopharmaceutical company in the commercialization stage by 2023[7]. - Everest Medicines' strategic transformation in 2022 is aimed at better adapting to the evolving market landscape[7]. - The company is committed to developing new vaccines for major infectious diseases and cancer using its clinically validated mRNA technology platform[12]. - The company aims to commercialize Xerava and Nefecon in 2023, actively building a commercialization team to ensure successful product launches[32]. - The company is preparing for the commercialization of Xerava and Nefecon, with a dedicated commercial team being established[40]. - The company plans to advance existing clinical trials and initiate new ones, aiming for rapid market entry of therapies and vaccines[41]. Clinical Development and Product Pipeline - Significant progress was made in clinical development, production capacity, and internal drug discovery throughout 2022, particularly in kidney and infectious diseases[8]. - The company submitted a New Drug Application (NDA) for Nefecon in China for the treatment of primary IgA nephropathy, based on positive Phase 3 clinical trial data from 62 patients[9]. - The mRNA vaccine production facility, operational since December 2022, has an annual capacity of 700 million doses, supporting the company's growth strategy[10]. - The clinical team achieved significant progress in advancing potential best-in-class therapies for kidney disease and infectious diseases, with the mRNA vaccine production capacity reaching 700 million doses annually at the new facility in Zhejiang, China[8]. - Nefecon (TarpeyoTM) showed a statistically significant improvement in eGFR, with an average increase of 5.05 mL/min/1.73 m² compared to placebo over two years, and the treatment demonstrated a decline of only -2.47 mL/min/1.73 m² versus -7.52 mL/min/1.73 m² for placebo[19]. - The National Medical Products Administration of China accepted the new drug application for Nefecon for primary IgA nephropathy, which is expected to receive priority review[18]. - Xerava received approval from the National Medical Products Administration of China for commercialization, marking it as the first product for the company in China[8]. - The company announced the successful preclinical proof of concept for the mRNA rabies vaccine, showcasing its internal drug discovery capabilities[23]. - The company is advancing a bivalent COVID-19 booster candidate vaccine targeting the Omicron variant, with ongoing rolling submissions for IND applications[22]. - EVER001, a next-generation BTK inhibitor for kidney disease, received IND approval for a Phase 1b clinical trial[19]. - The company expects to submit new drug applications for Nefecon in South Korea, Hong Kong, and Taiwan in 2023[19]. - The company plans to submit a new drug application for Taniborbactam for treating cUTI in China in 2023[26]. - EVER206 showed good tolerability in a Phase 1 clinical study with no acute kidney injury observed, supporting its progression to Phase 3 trials[26]. - Etrasimod achieved a clinical remission rate of 27.0% at week 12 in the ELEVATE UC study, compared to 7.4% for the placebo group, with a significant difference of 19.8%[28]. - The FDA is expected to make a decision on the new drug application for Etrasimod in the second half of 2023, marking its first potential approval globally[28]. Collaborations and Licensing Agreements - The company established an exclusive collaboration with Taiwan Dongyang Pharmaceutical for the commercialization of Xerava in Taiwan[9]. - The company signed a licensing agreement with Calliditas for Nefecon in South Korea, expanding its international commercial footprint[30]. - The agreement with Immunomedics allows the company to receive up to $455 million, including an upfront payment of $280 million, for the development and commercialization of Trodelvy in several regions[30]. - The company has established an exclusive collaboration with Taiwan Dongyang for the commercialization of Xerava in Taiwan, leveraging their experience in launching new antibiotics[24]. Governance and Management - The company is committed to maintaining a strong governance structure with a diverse board composition[186]. - The management team includes experienced professionals from various sectors, enhancing the company's strategic capabilities[191]. - The company has established a remuneration committee to determine and recommend compensation policies for directors and senior management[168]. - The company emphasizes the importance of strong governance with the appointment of independent directors to enhance oversight and strategic direction[193][194][196]. - The company has not entered into any management or administrative contracts for the majority of its business as of December 31, 2022[101]. - The board consists of four executive directors, two non-executive directors, and three independent non-executive directors as of the last practicable date[186]. - Mr. Luo Yongqing was appointed as the CEO and executive director on September 19, 2022, bringing over 25 years of experience in the healthcare industry[186]. - The company has not disclosed any significant events affecting its operations since the end of the reporting period[184]. Employee and Compensation - The group reported a total employee compensation cost of RMB 853.1 million for the year ended December 31, 2022, an increase from RMB 574.8 million in the previous year[88]. - As of December 31, 2022, the group had 365 employees, a decrease from 405 employees in 2021[85]. - The group’s clinical development team comprised 36.16% of total employees, indicating a strong focus on this area[86]. - The total compensation for directors for the year ended December 31, 2022, was approximately RMB 68.7 million[168]. - The company has granted stock options to directors, with Mr. Luo Yongqing eligible for up to 4,700,000 shares under the post-IPO stock option plan[105]. Market and Investment - The Hong Kong-listed biotechnology sector showed signs of recovery in late 2022, positively impacting investor sentiment towards Everest Medicines[7]. - The company has established a strong product pipeline, including potential first-in-class or best-in-class therapeutic assets and mRNA vaccines, covering short, medium, and long-term opportunities[33]. - The company has entered into a licensing agreement with Calliditas to expand rights in Greater China and Singapore to Korea[37]. - The company plans to fully utilize the remaining unutilized net proceeds by the second half of 2024[181]. - The company has not been involved in any significant litigation or arbitration as of December 31, 2022[176]. Risk Factors - The group faced significant risks including financial condition, clinical development uncertainties, and reliance on business partners and third parties[81]. - The group has no significant contingent liabilities as of December 31, 2022, indicating a stable financial position[70]. - The company has not entered into any hedging transactions to manage foreign currency risks, which may affect operational performance due to currency fluctuations[71].

Stock Performance and Market Sentiment - Everest Medicines Limited's stock price increased over 300% from a low of HKD 6.18 on October 31, 2022, to January 31, 2023, following the announcement of a new strategic direction[8] - The Hong Kong-listed biotechnology index rebounded in late 2022, positively impacting investor sentiment towards Everest Medicines[8] Strategic Direction and Leadership - The company plans to streamline operations and focus on key therapeutic areas with strong market potential after divesting Trodely to Gilead Sciences[8] - A new CEO, Luo Yongqing, was appointed in September 2022 to lead the company into a new phase of growth and commercialization[8] - The company is committed to seeking business development opportunities to introduce globally licensed assets while developing its internal capabilities[8] Clinical Development and Product Pipeline - Significant progress was made in clinical development, manufacturing capabilities, and internal drug discovery throughout 2022[9] - The company aims to leverage its clinically validated mRNA technology platform to advance projects in key therapeutic areas[8] - The company submitted a New Drug Application (NDA) for Nefecon in China for the treatment of primary IgA nephropathy, based on positive Phase 3 clinical trial data involving 62 patients[10] - The mRNA COVID-19 vaccine candidate PTX-COVID19-B demonstrated statistical non-inferiority in neutralizing antibodies compared to Comirnaty® in a head-to-head clinical trial, providing clinical validation for the mRNA platform[10] - Xerava has been approved for the treatment of complicated intra-abdominal infections in Hong Kong and Singapore, with commercialization achieved in Singapore in 2022[10] - The company achieved significant progress in various aspects of its business and pipeline as of December 31, 2022, including the acceptance of the new drug application for Nefecon by the National Medical Products Administration (NMPA) in China[17] Financial Performance - The company reported a net loss of RMB 247.3 million for the year ended December 31, 2022, a significant reduction from a loss of RMB 1,008.7 million in 2021, largely due to other income from the Trodelvy® transaction[14] - The adjusted loss for the year ended December 31, 2022, was RMB 17.4 million, a significant improvement from RMB 77.3 million in 2021[15] - The company's revenue for the year ended December 31, 2022, was RMB 12.8 million, compared to RMB 12.8 million for the year ended December 31, 2021[41] - Other net income surged to RMB 1,143.4 million in 2022 from RMB 22.9 million in 2021, primarily attributed to the sale proceeds from the Trodelvy® transaction[48] - The loss attributable to equity holders of the company decreased from RMB 1,008.7 million in 2021 to RMB 247.3 million in 2022, mainly due to the sale proceeds from the Trodelvy® transaction[54] Research and Development Expenses - Research and development (R&D) expenses increased from RMB 613.4 million in 2021 to RMB 809.7 million in 2022, primarily due to additional clinical trials and expanded internal drug discovery capabilities[14] - Distribution and selling expenses rose from RMB 198.2 million in 2021 to RMB 326.7 million in 2022, mainly due to increased employee benefits and pre-commercialization activities[44] - General and administrative expenses increased from RMB 242.7 million in 2021 to RMB 276.5 million in 2022, primarily due to higher professional service fees[45] Manufacturing and Production Capacity - The mRNA vaccine production facility commenced operations in December 2022, with an annual production capacity of 700 million doses[11] - The global production facility in Jiaxing, Zhejiang, commenced operations in December 2022, with an annual production capacity of 700 million doses for mRNA vaccines[17] - The company completed the first phase of its Jiaxing factory construction in September 2022, with mRNA vaccine production starting in December 2022[30] Regulatory Approvals and Market Launch - The company expects to obtain new drug marketing approval for Nefecon in mainland China and Singapore in 2023[19] - Xerava received approval from the NMPA for commercialization in China, marking it as the first product for the company in the region[17] - The company plans to establish an internal commercialization team for Xerava and Nefecon in preparation for their market launch in 2023[13] Risk Management and Corporate Governance - The company has faced several key risks, including uncertainties in clinical development outcomes and reliance on business partners and third parties[77] - The company has a robust corporate governance culture that reflects its commitment to ethical business practices[185] - The company has adopted the corporate governance code as a baseline for its governance practices, ensuring compliance throughout the reporting period[186] Shareholder and Employee Matters - The board did not recommend the payment of a final dividend for the year ended December 31, 2022, consistent with the previous year[89] - The company reported a total employee count of 365 as of December 31, 2022, down from 405 in 2021, with 36.16% in clinical development[81] - Total employee compensation costs amounted to RMB 853.1 million for the year ended December 31, 2022, compared to RMB 574.8 million for the previous year[83] Future Outlook and Strategic Initiatives - The company plans to expand its market presence and is exploring new product development strategies[149] - The company is actively exploring acquisition opportunities in key therapeutic areas to enhance its growth strategy[34] - The management team highlighted a strategic shift towards digital transformation, aiming for a G% increase in online sales channels[176]

Financial Performance - Net loss for the period increased from RMB 383.1 million to RMB 668.0 million, reflecting a rise of 77.5%[7] - The company reported a loss of RMB 668.0 million for the six months ended June 30, 2022, compared to a loss of RMB 383.1 million for the same period in 2021[29] - Basic loss per share for the period was RMB (2.26), compared to RMB (1.31) in the previous year, indicating a worsening of loss per share[93] - The total comprehensive income for the six months ended June 30, 2022, was RMB (135,768) thousand, compared to RMB 931,614 thousand for the same period in 2021[198] Revenue and Expenses - Total revenue for the six months ended June 30, 2022, was RMB 1,044,000, compared to no revenue in the same period of 2021[93] - Gross profit for the same period was RMB 680,000, resulting in a gross margin of approximately 65%[93] - Total expenses for the six months ended June 30, 2022, amounted to RMB 5,511,000, a significant increase from RMB 2,876,000 in the same period of 2021, indicating an increase of 91.1%[135] - Research and development expenses increased from RMB 250.8 million in the six months ended June 30, 2021, to RMB 345.5 million in the six months ended June 30, 2022, a rise of 37.2%[7] Cash Flow and Liquidity - Cash and cash equivalents decreased from RMB 2,640.1 million as of December 31, 2021, to RMB 1,956.8 million as of June 30, 2022, mainly due to cash used in operating activities[46] - Net cash used in operating activities for the six months ended June 30, 2022, was RMB 515.4 million, compared to RMB 388.5 million for the six months ended June 30, 2021[47] - The current ratio as of June 30, 2022, was 2.37, compared to 30.22 as of June 30, 2021[51] Research and Development - The company has initiated over 10 discovery projects across various therapeutic areas, including oncology and mRNA vaccines[25] - The company plans to submit a new drug application for NEFECON in China for IgAN in the second half of 2022[12] - The company is preparing for multiple product launches in the next one to two years, supported by a newly established commercialization team with decades of experience in innovative drugs[9] Clinical Trials and Approvals - The company announced participation in a clinical trial collaboration with Gilead Sciences and Merck to evaluate sacituzumab govitecan in combination with Keytruda for NSCLC treatment[9] - Trodelvy® (sacituzumab govitecan) demonstrated a 34% reduction in the risk of disease progression or death in hormone receptor-positive, HER2-negative metastatic breast cancer patients, with a median progression-free survival (PFS) of 5.5 months compared to 4 months[10] - Trodelvy® received approval from the National Medical Products Administration in China for the treatment of adult patients with second-line metastatic triple-negative breast cancer (TNBC), marking the company's first innovative drug approved in China[10] Shareholder Structure and Equity - The company reported a significant shareholder structure, with Vistra Trust (Singapore) Pte. Limited holding approximately 44.69% of the shares[72] - C-Bridge Capital GP, Ltd. and its associated funds collectively own about 17.60% of the shares, indicating strong institutional support[72] - The total number of shares issued as of June 30, 2022, was 299,807,605, which is crucial for calculating ownership percentages[70] Stock Options and Incentives - The company has granted stock options to key executives, with exercise prices ranging from $0.18 to $72.49 HKD, reflecting a structured incentive plan[70] - The company has a total of 27,190,456 unexercised options as of June 30, 2022, with a weighted average exercise price of $2.57[190] - The total share-based compensation expense recognized for restricted shares for the six months ended June 30, 2022, was RMB 86,295 thousand, compared to RMB 47,777 thousand for the same period in 2021[187] Financial Position - Total assets decreased to RMB 5,922,869 from RMB 6,645,823, representing a decline of approximately 11%[94] - Total liabilities increased to RMB 963,542 from RMB 753,827, marking an increase of approximately 28%[95] - The company's total equity decreased to RMB 4,959,327 from RMB 5,891,996, reflecting a decline of about 16%[95] Strategic Partnerships and Collaborations - A partnership with China Resources Pharmaceutical Group was established to develop and commercialize mRNA vaccines, enhancing the company's position in the mRNA vaccine market[14] - The company entered into collaboration and licensing agreements with Arena Pharmaceuticals, involving milestone payments totaling RMB 41.1 million for development and commercialization efforts[142] Future Outlook - The company is positioned for future growth, with a focus on expanding its market presence and enhancing shareholder value through strategic initiatives[69] - The company plans to fully utilize the remaining unutilized proceeds by the second half of 2023[67]

Business Growth and Development - In 2021, Everest Medicines achieved significant milestones across its business sectors, expanding its workforce to over 400 employees, more than doubling from the end of 2020[10]. - The company successfully completed patient recruitment for its Phase 2b bridging study (EVER-132-001) within three months, achieving top-line results that meet global quality standards[10]. - Everest Medicines submitted multiple New Drug Applications (NDA) and a Biologics License Application (BLA) for Trodelvy in Greater China, Singapore, and South Korea for the treatment of adult patients with second-line and later metastatic triple-negative breast cancer (TNBC)[10]. - The company also submitted an NDA for Xerava in mainland China and Hong Kong for the treatment of adult patients with complicated intra-abdominal infections[10]. - Everest Medicines is advancing its late-stage assets into other indications, including developing Trodelvy for HR+/HER2- metastatic breast cancer and other cancers[12]. - The company anticipates stable progress on clinical data milestones for Trodelvy, Xerava, Nefecon, etrasimod, and other assets in its pipeline throughout 2022[12]. - Despite the challenging environment, Everest Medicines continued to accelerate high-quality clinical trials and expand its global footprint by establishing teams in South Korea, Singapore, and Taiwan[10]. - The company is positioned as a commercially capable biopharmaceutical company with expectations for NDA and BLA approvals in 2022[10]. - The company established a new drug discovery team of 26 professionals to enhance its internal R&D capabilities[13]. - The company expanded its new drug discovery and commercialization capabilities, moving into a new 1,700 square meter research center in Zhangjiang, focusing on oncology, nephrology, and mRNA vaccine projects[22]. - The commercial team has grown to 128 members by December 31, 2021, preparing for multiple product launches in 2022[22]. Financial Performance - The net loss for the year ended December 31, 2021, decreased to RMB 1,008.7 million from RMB 5,658.2 million, mainly due to a reduction in losses from the fair value changes of financial instruments issued to investors[19]. - The adjusted loss for the year was RMB 777.3 million, an increase of RMB 174.4 million compared to RMB 602.9 million in the previous year, primarily due to increased R&D and distribution expenses[20]. - As of December 31, 2021, the company's R&D expenses increased by RMB 236 million to RMB 613.4 million, primarily due to an increase in clinical trial numbers and the expansion of the internal drug discovery team[19]. - General and administrative expenses decreased by RMB 35.1 million to RMB 242.7 million, mainly due to reduced expenses related to the company's public listing in 2020[19]. - Distribution and selling expenses rose by RMB 165 million to RMB 198.2 million, attributed to the expansion of the commercial organization and pre-commercialization activities[19]. - The company's cash and cash equivalents decreased from RMB 4,481.1 million as of December 31, 2020, to RMB 2,640.1 million as of December 31, 2021, primarily due to upfront payments related to licensing agreements and investments in R&D projects and commercialization activities[73]. - Net cash used in operating activities for the year ended December 31, 2021, was RMB 729.9 million, compared to RMB 471.9 million for the year ended December 31, 2020, with the net loss for the respective years being RMB 1,008.7 million and RMB 5,658.2 million[74]. - Net cash used in investing activities for the year ended December 31, 2021, was RMB 975.8 million, primarily due to the purchase of intangible assets amounting to RMB 865.9 million[76]. - The adjusted loss for the year ended December 31, 2021, was RMB 777.3 million, compared to RMB 602.9 million for the year ended December 31, 2020, reflecting the impact of non-cash items and one-time events[72]. Clinical Trials and Drug Development - The FDA approved TrodelvyTM for treating adult patients with second-line metastatic TNBC, showing a 57% reduction in the risk of disease progression or death, with median progression-free survival (PFS) extended from 1.7 months to 4.8 months[23]. - The overall response rate (ORR) for TrodelvyTM in the TROPHY study was 27.7%, with a median response duration of 7.2 months, based on data from 112 patients[25]. - The company announced a 38.8% ORR in the EVER-132-001 bridging study for sacituzumab govitecan in adult patients with previously treated unresectable locally advanced or metastatic TNBC[25]. - The company is conducting a Phase 3 study to evaluate sacituzumab govitecan's efficacy and safety in Asian patients with hormone receptor-positive, HER2-negative metastatic breast cancer, recruiting approximately 330 patients[26]. - The company is transforming into an integrated Asian biopharmaceutical company, focusing on global quality and local speed in asset advancement[22]. - Nefecon (TarpeyoTM) is a key candidate for treating primary IgA nephropathy, with the NefIgArd Phase 3 global registration trial completed for Chinese patient recruitment[29]. - Calliditas Therapeutics received accelerated review for Nefecon's MAA in April 2021, with a potential conditional approval in Q2 2022[29]. - TARPEYO was approved by the FDA as the first and only treatment for reducing proteinuria in adults with primary IgA nephropathy, showing a 34% reduction in proteinuria at 9 months compared to 5% with RASi[31]. - The company is actively pursuing partnerships to enhance its product pipeline and secure global rights for innovative therapies[47]. Market Position and Strategic Initiatives - The biotechnology sector faced challenges in 2021, with the Hang Seng Hong Kong-listed biotech index dropping over 27%, reflecting market uncertainties[10]. - The company was recognized as one of the "Top 10 Leading Companies in ADC Drugs" at the BioChina summit in June 2021[17]. - The company was included in major global stock indices, enhancing its visibility and liquidity in the capital markets[17]. - The company aims to continue its commitment to high-quality standards and innovation in drug development to meet unmet medical needs[17]. - The company is focused on expanding its market presence, particularly in China, Japan, and other Asian markets, under the leadership of Chief Commercial Officer Mr. Guo Yong[185]. - The company is exploring new markets, particularly in Asia, to leverage growth opportunities and diversify its revenue streams[178]. - The company aims to expand its market share by X% in the upcoming year through targeted marketing strategies and partnerships[173]. Corporate Governance and Leadership - The board of directors includes a mix of executive, non-executive, and independent non-executive members[85]. - The company has established a robust governance structure with independent directors on its board, ensuring accountability and strategic oversight[179]. - The board of directors consists of four executive directors, two non-executive directors, and three independent non-executive directors[192]. - The company has adopted the principles and code provisions of the Corporate Governance Code as its corporate governance standard[190]. - The company has complied with all applicable code provisions of the Corporate Governance Code during the reporting period[190]. - The company has a strong leadership team with significant experience in the pharmaceutical industry, including roles at major companies like Bayer and AstraZeneca[182]. - The company appointed Mr. Tan Bo as an independent non-executive director and chairman of the remuneration committee in September 2020, bringing extensive experience in finance and pharmaceuticals[179]. - The company has appointed a Chief Scientific Officer with over 20 years of experience in drug discovery and development[187]. Research and Development Focus - The company is funding ongoing and planned clinical trials for its core candidate drug, Etrasimod, with a budget allocation of 15%, amounting to HKD 569 million, of which HKD 556 million has been utilized[160]. - For the drug Sacituzumab Govitecan-hziy, the company allocated 20% of its funding, totaling HKD 759 million, with HKD 746 million already utilized[160]. - The company has allocated 10% of its funding, amounting to HKD 380 million, for the ongoing and planned clinical trials of Nefecon, with HKD 337 million utilized[160]. - The company is committed to enhancing its research and development efforts to bring new therapies to market[184]. - The company is actively developing new products and technologies, with a dedicated team of medical and scientific experts[184]. Future Outlook - Future outlook remains positive, with management expressing confidence in achieving long-term growth targets despite market challenges[175]. - The company plans to fully utilize the remaining unutilized funds by the second half of 2023[164]. - The company aims to expand the development of sacituzumab govitecan for new indications in collaboration with Gilead, targeting mUC, HR+/HER2- mBC, NSCLC, and other TROP-2 high-expressing cancers[50].

Financial Performance - Net loss decreased from RMB 623.5 million to RMB 383.1 million, primarily due to a reduction in fair value losses on financial instruments issued to investors[5]. - Other comprehensive income increased from RMB 282.6 million to RMB 567.3 million, mainly due to increased income from fair value changes of financial assets[5]. - The company recorded a loss of RMB 383.1 million for the six months ended June 30, 2021, compared to a loss of RMB 623.5 million for the same period in 2020[26]. - The loss attributable to equity holders of the company decreased from RMB 623.5 million for the six months ended June 30, 2020, to RMB 383.1 million for the same period in 2021, mainly due to a reduction in the fair value loss on financial instruments issued to investors[37]. - The adjusted loss attributable to equity holders for the six months ended June 30, 2021, was RMB 303.1 million, compared to RMB 245.9 million for the same period in 2020[40]. - The company reported a net loss of RMB 383,108 thousand for the six months ended June 30, 2021, an improvement from a net loss of RMB 623,531 thousand in the same period of 2020, representing a reduction of approximately 38.6%[124]. - Basic and diluted loss per share for the six months ended June 30, 2021, was RMB 1.31, significantly improved from RMB 25.06 in the same period of 2020[124]. Research and Development - R&D expenses increased from RMB 161.0 million for the six months ended June 30, 2020, to RMB 250.8 million for the six months ended June 30, 2021, primarily due to additional clinical trials and team expansion[5]. - The company has six clinical-stage candidates, including sacituzumab govitecan-hziy and etrasimod, undergoing registration trials for eight different indications[10]. - The company is actively recruiting top talent for its drug discovery team and establishing a research facility in Zhangjiang, Shanghai[11]. - The company anticipates announcing multiple late-stage clinical trial data in 2021 and 2022, along with submitting additional new drug applications[10]. - The company completed patient recruitment for the NefIgArd Phase 3 global registration trial of Nefecon for treating IgA nephropathy in China[8]. - The company initiated a Phase 2 basket trial in China to evaluate sacituzumab govitecan-hziy in 180 patients with various TROP-2 high-expressing cancers[15]. - The company is conducting a multi-regional trial for Etrasimod in ulcerative colitis across China, Korea, and Taiwan[12]. Clinical Trials and Approvals - The company’s candidate drug, sacituzumab govitecan-hziy, received priority review from the National Medical Products Administration in China for treating advanced or metastatic triple-negative breast cancer[6]. - The company received approval from the National Medical Products Administration of China in March 2021 for a clinical trial of sacituzumab govitecan-hziy to treat 180 patients with recurrent or refractory esophageal squamous cell carcinoma, gastric cancer, and cervical cancer[7]. - The company’s partner, Gilead Sciences, received full approval from the FDA for TrodelvyTM for treating metastatic triple-negative breast cancer[6]. - A global Phase 3 registration clinical trial for sacituzumab govitecan-hziy in treating metastatic urothelial carcinoma has been initiated, with the first patient dosed in China in August 2021[6]. - An Asian Phase 3 study has been launched to evaluate the efficacy and safety of sacituzumab govitecan-hziy in hormone receptor-positive, HER2-negative metastatic breast cancer patients[6]. - The company plans to submit a new drug application for sacituzumab govitecan-hziy in South Korea and Taiwan in the second half of 2021[24]. Financial Position and Cash Flow - As of June 30, 2021, cash and cash equivalents amounted to RMB 3,971.0 million[5]. - Net cash used in operating activities for the six months ended June 30, 2021, was RMB 388.5 million, compared to RMB 219.9 million for the same period in 2020[43]. - Cash used in investing activities for the six months ended June 30, 2021, was RMB 83.1 million, primarily for the purchase of intangible assets[44]. - The company is in a net cash position as of June 30, 2021, making the debt-to-equity ratio not applicable[46]. - The company recorded a foreign exchange loss of RMB 31,328 thousand for the six months ended June 30, 2021, compared to a gain of RMB 385 thousand in the same period of 2020[120]. - The company has maintained 100% ownership in its subsidiaries, including Everest Medicines (US) Limited and Everest Medicines (Singapore) Pte. Limited, as of June 30, 2021[97]. Employee Compensation and Team Expansion - General and administrative expenses rose from RMB 101.3 million to RMB 107.4 million during the same period, mainly due to increased employee compensation from team expansion[5]. - Total employee compensation for the six months ended June 30, 2021, was RMB 212.6 million, compared to RMB 137.6 million for the same period in 2020, representing a 54.4% increase[51]. - The company employed a total of 227 full-time employees as of June 30, 2021, with 48% in clinical development[51]. - The company appointed a new Chief Commercial Officer in February 2021 to lead commercial planning and execution[9]. - The company appointed Dr. Yang Wei as Chief Scientific Officer on April 15, 2021, to strengthen its drug discovery organization[23]. Strategic Partnerships and Collaborations - The company established a commercial team focused on oncology, internal medicine, and infectious diseases, expanding its geographical coverage with new offices in South Korea, Taiwan, and Singapore[10]. - The company entered into a comprehensive agreement with Providence to promote mRNA vaccines and therapies in emerging Asian markets[10]. - The company established strategic partnerships with Tencent Holdings, Sipai Health Technology, and Meixin Health Technology to explore innovative solutions for drug accessibility and patient affordability[22]. - The company has established collaboration and licensing agreements with Arena Pharmaceuticals and Tetraphase Pharmaceuticals for the development and commercialization of specific products in various regions[134]. Shareholder Information and Equity Structure - The company has a significant shareholder, Vistra Trust (Singapore) Pte. Limited, holding 44.29% of the ordinary shares[64]. - C-Bridge Healthcare Fund GP IV, L.P. holds 18.02% of the company's ordinary shares, totaling 53,639,823 shares[65]. - C-Bridge Capital GP, Ltd. and its affiliates collectively own 16.79% of the company, with 50,000,000 shares each[66]. - The company has a total of 297,718,750 shares issued as of June 30, 2021[62]. - The company has granted unexercised options for a total of 20,267,908 shares under the pre-IPO share incentive plan[71]. Future Outlook and Plans - The company aims to expand its innovative drug portfolio through licensing and building its own drug discovery capabilities in unmet medical needs[24]. - The company plans to submit a new drug application for Nefecon to the National Medical Products Administration in China in the first half of 2022[18]. - The company expects to announce the top-line results of the Phase 2 registration clinical trial EVER-132-001 for metastatic TNBC in China in the second half of 2021[17]. - The company is focused on expanding its market presence and enhancing its product pipeline through strategic investments and partnerships in the biopharmaceutical sector[96].

Financing and IPO - Everest Medicines completed a $310 million Series C financing and successfully conducted an IPO on the Hong Kong Stock Exchange[23]. - The company was included in the Hang Seng Index within six months of becoming a public company[23]. - The company’s stock was included in the Hang Seng Composite Index and the Hang Seng Healthcare Index starting March 15, 2021, meeting the standards for inclusion in the Hong Kong Stock Connect[33]. - Cash and cash equivalents increased from RMB 1,061.0 million as of December 31, 2019, to RMB 4,481.1 million as of December 31, 2020, primarily due to C round financing and IPO proceeds[59]. - Net cash generated from financing activities for the year ended December 31, 2020, was RMB 5,637.9 million, primarily from the global IPO and C round financing[63]. Clinical Development and Regulatory Milestones - The first new drug application was approved in Singapore, and the company completed a Phase 3 registration clinical trial in China[23]. - The company aims to transform into a commercial growth stage with significant late-stage clinical and regulatory milestones planned for 2021[24]. - The company submitted a new drug application for Sacituzumab govitecan-hziy for mTNBC in Singapore in January 2021, which was accepted by the Health Sciences Authority[30]. - A Phase 2 registration clinical trial for Sacituzumab govitecan-hziy in mTNBC commenced in China in November 2020 and is ongoing[30]. - Nefecon was granted breakthrough therapy designation for the treatment of IgAN by the National Medical Products Administration in December 2020[31]. - The company plans to initiate patient recruitment for the global Phase 3 TROPiCS-04 trial in China, evaluating sacituzumab govitecan-hziy in mUC patients[40]. - The company anticipates key data analysis results for the Phase 2b trial of sacituzumab govitecan-hziy in mTNBC in China by the second half of 2021[40]. - The company is conducting a Phase 2/3 clinical trial for Crohn's disease and plans to initiate a Phase 3 trial for atopic dermatitis[38]. - Nefecon demonstrated significant efficacy in a global Phase 3 trial, showing a statistically significant reduction in urinary protein-creatinine ratio after 9 months of treatment in 199 primary IgAN patients[41]. Financial Performance - The net loss for the year increased significantly from RMB 214.5 million in 2019 to RMB 5,658.2 million in 2020, primarily due to a loss of RMB 4,938.0 million from the fair value changes of financial instruments issued to investors[27]. - Adjusted net loss for the year was RMB 602.9 million, up from RMB 163.1 million in 2019, an increase of RMB 439.8 million, mainly due to higher R&D and general administrative expenses[28]. - General and administrative expenses rose from RMB 53.9 million in 2019 to RMB 277.8 million in 2020, an increase of RMB 223.9 million, mainly due to IPO costs and increased employee compensation[27]. - Research and development expenses rose from RMB 150.9 million in 2019 to RMB 377.4 million in 2020, attributed to additional clinical trials for candidate drugs and expansion of the R&D team[48]. - The company reported a loss of RMB 5,658.2 million for the year ended December 31, 2020, compared to a loss of RMB 214.5 million for the year ended December 31, 2019[46]. Employee and Organizational Development - The company emphasizes the importance of its employees in achieving long-term growth and fostering a culture of personal development[25]. - Everest Medicines is dedicated to establishing productive partnerships and investing in young talent to support its team[25]. - The total employee compensation expense for the year ended December 31, 2020, was RMB 309.3 million, compared to RMB 152.6 million in 2019, reflecting a 102% increase[71]. - The company employed a total of 149 full-time employees as of December 31, 2020, with 56% in clinical development and business development roles[70]. - The company has adopted share plans to incentivize employees[82]. Governance and Risk Management - The board of directors includes four executive directors, two non-executive directors, and three independent non-executive directors, ensuring a diverse governance structure[143]. - The company has established three committees: the Audit Committee, the Remuneration Committee, and the Nomination Committee to oversee various aspects of the company's affairs[169]. - The board is responsible for leading and controlling the company, ensuring good internal control and risk management systems are in place[167]. - The company acknowledges that risk management is crucial for operational success, facing major operational risks including regulatory changes in the pharmaceutical market and competition with other pharmaceutical companies[187]. - The company has implemented a risk management framework to ensure appropriate application across departments[189]. Corporate Social Responsibility and Sustainability - The company is committed to fulfilling social responsibilities and promoting employee welfare and development[81]. - The environmental, social, and governance report covers the company's management policies and performance for the fiscal year 2020[198]. - The report outlines the company's initiatives regarding significant environmental, social, and governance matters, providing transparency and accountability to stakeholders[200]. - The company aims to provide clear insights into its environmental initiatives[200]. - Stakeholder engagement is a key focus in the company's sustainability efforts[200].