Financial Performance - Revenue for the first half of 2023 was RMB 153,553 thousand, with a gross profit of RMB 147,798 thousand[8]. - Operating loss for the first half of 2023 was RMB 117,995 thousand, significantly improved from a loss of RMB 370,695 thousand in the same period of 2022[8]. - The company's net loss for the six months ended June 30, 2023, was RMB 141.9 million, down from RMB 348.4 million in the same period of 2022[36]. - For the six months ended June 30, 2023, the company recorded revenue of RMB 153.6 million, compared to zero for the same period in 2022[28]. - The company reported a significant increase in revenue, achieving a total of RMB 1.2 billion for the first half of 2023, representing a year-on-year growth of 25%[136]. - The company reported a significant increase in revenue for the first half of 2023, reaching RMB 1.5 billion, representing a year-on-year growth of 25%[145]. - The gross margin for the first half of 2023 was reported at 65%, reflecting an improvement from 60% in the same period last year[145]. Assets and Liabilities - Total assets as of June 30, 2023, were RMB 2,399,766 thousand, a decrease from RMB 2,529,172 thousand as of December 31, 2022[8]. - Total liabilities as of June 30, 2023, were RMB 1,637,534 thousand, slightly increased from RMB 1,628,410 thousand as of December 31, 2022[8]. - Equity as of June 30, 2023, was RMB 762,232 thousand, down from RMB 900,762 thousand at the end of 2022[8]. - The company's debt-to-asset ratio increased to 68.24% as of June 30, 2023, compared to 64.39% as of December 31, 2022[39]. - The company reported a significant increase in bank borrowings, with current borrowings rising to RMB 469,365 thousand from RMB 359,988 thousand, an increase of about 30.5%[71]. - The company’s total liabilities increased to RMB 749,365,000 as of June 30, 2023, compared to RMB 650,045,000 as of December 31, 2022, marking a rise of 15.3%[115]. Research and Development - Research and development expenses for the first half of 2023 were RMB 231,872 thousand, slightly increased from RMB 230,706 thousand in the previous year[8]. - The company is focusing on developing innovative ADCs and has established a professional sales and marketing team for commercialization[9]. - The company is actively exploring the potential efficacy of MRG003 in other common cancers with EGFR overexpression[14]. - The company aims to accelerate the development of two main ADC products, MRG003 and MRG002, targeting the NDA stage and registration clinical studies respectively[27]. - Research and development efforts have led to the advancement of two new monoclonal antibodies, expected to enter clinical trials by Q4 2023[139]. - The company has invested RMB 200 million in new technology for ADC development, aiming to improve therapeutic efficacy[145]. Clinical Trials and Product Development - The company has multiple oncology product pipelines, including one drug in the commercial stage and six candidates in clinical stages[9]. - Five clinical trials are currently ongoing in China, with one trial in the United States[9]. - MRG003 has received FDA's NPC ODD and CDE's BTD, while MRG002 has received FDA's GC/GEJ ODD[9]. - The company is conducting a Phase II clinical trial for MRG003 targeting multiple EGFR-expressing cancers, with promising data observed in NPC and HNSCC studies[14]. - MRG002, an innovative HER2-targeted ADC, is in a Phase III clinical trial for HER2-positive breast cancer, with patient enrollment completed[15]. - The company has initiated a Phase I trial for the combination of MRG003 and Puyuheng® in solid tumors, with positive preliminary data expected to be presented at the 2023 CSCO annual meeting[17]. - The company has initiated registration clinical trials for multiple ADC candidates, including MRG003 in NPC and MRG002 in UC, indicating significant progress in their clinical pipeline[21]. Licensing and Partnerships - The company received approximately RMB 109.5 million from KYM as part of a licensing agreement with AstraZeneca for the development and commercialization of CMG901, with potential total payments up to USD 1.188 billion[12]. - A global exclusive licensing agreement with AstraZeneca for CMG901 includes an upfront payment of $63 million and potential additional payments of up to $1.125 billion upon achieving certain milestones[22]. - The company is actively seeking potential business development cooperation opportunities with overseas companies to expand its ADC product pipeline globally[27]. Market Expansion and Strategic Outlook - The company is planning to expand its market presence in Southeast Asia, targeting a 15% market share within the next two years[140]. - The company has provided a positive outlook for the second half of 2023, projecting a revenue growth of 20% to 25% driven by new product launches and market expansion efforts[138]. - The company is exploring potential acquisitions to bolster its product pipeline and enhance competitive positioning in the oncology market[138]. - The company is considering strategic acquisitions to enhance its product portfolio, with a target of completing at least one acquisition by Q4 2023[144]. Shareholder Information - As of June 30, 2023, the board members held significant shares, with Dr. Pu Zhongjie owning 41.03% of the H shares[50]. - The company has a total of 1,659,444,838 shares issued, including 1,605,176,474 H shares and 54,268,364 domestic shares[50]. - The company maintains a diverse shareholder base with various entities holding significant stakes in both H shares and domestic shares[55]. Corporate Governance - The company has adopted and complied with the principles and code provisions of the Corporate Governance Code during the reporting period[61]. - There were no significant changes in the directors, supervisors, and senior management of the company during the reporting period[61]. - The independent auditor has reviewed the interim financial information in accordance with the International Standard on Review Engagements[62].

Financial Performance - Total revenue for the six months ended June 30, 2023, was approximately RMB 153.6 million, compared to zero for the same period in 2022[3]. - Loss attributable to shareholders for the six months ended June 30, 2023, decreased by approximately RMB 202.4 million to about RMB 141.9 million, a reduction of approximately 58.8% compared to the same period in 2022[3]. - The group reported a net loss of RMB 141.9 million for the six months ended June 30, 2023, compared to a net loss of RMB 348.4 million for the same period in 2022[37]. - The group recorded a fair value gain of RMB 17,737,000 on financial liabilities measured at fair value through profit or loss for the six months ended June 30, 2023, compared to a loss of RMB 60,776,000 in the prior year[54]. - Basic loss per share for the six months ended June 30, 2023, was RMB (0.09), an improvement from RMB (0.21) in the same period of 2022[57]. - Total expenses for the six months ended June 30, 2023, amounted to RMB 290,558,000, a decrease from RMB 315,635,000 in the same period of 2022[53]. Revenue Sources - The company received approximately RMB 109.5 million in licensing income from KYM as part of a global exclusive licensing agreement with AstraZeneca, with potential additional payments of up to USD 1.125 billion[2]. - Sales revenue for the product 普佑恆® (Putilimumab Injection) during the reporting period was RMB 44.0 million[2]. - The group reported revenue of RMB 109,520,000 from licensing income, accounting for 71.32% of total revenue for the six months ended June 30, 2023[51]. - Sales of pharmaceutical products generated RMB 44,033,000 during the same period, contributing to total revenue of RMB 153,553,000[50]. Clinical Development - The company is advancing multiple clinical trials, including MRG003 for NPC and HNSCC, with encouraging data expected to be presented at the 2023 ESMO conference[3]. - MRG002 has completed patient enrollment for its registration clinical trial in China and is progressing towards NDA stage[3]. - MRG004A is undergoing I/II phase clinical studies in the US and China, with preliminary data to be presented at the 2023 CSCO conference[3]. - The company is conducting a Phase II clinical trial for MRG003 targeting multiple EGFR-expressing cancers, with promising data observed in HNSCC and NPC[8]. - The registration clinical trial for MRG002 in HER2-positive breast cancer has completed patient enrollment and is advancing towards NDA stage[9]. - The company is conducting a Phase III clinical trial for MSI-H/dMMR metastatic colorectal cancer as a confirmatory study for conditional marketing approval[10]. - MRG003 and Putilizumab combination therapy has shown encouraging preliminary data in a Phase I trial, with further results to be presented at the 2023 CSCO annual meeting[11]. - The company has initiated a Phase I/II clinical study for MRG004A, an innovative ADC drug, in the US and China, with preliminary data expected to be presented at the 2023 CSCO annual meeting[11]. - The company is exploring the potential efficacy of MRG002 in combination with Putilizumab for HER2-expressing solid tumors in an ongoing Phase I trial[11]. - The company has received IND approval from the National Medical Products Administration for a Phase I trial of CG0070 in combination with Putilizumab for BCG-unresponsive NMIBC patients[11]. - As of June 30, 2023, the company is actively enrolling patients in various clinical trials across multiple indications, reflecting a robust pipeline of candidate drugs[7]. Strategic Initiatives - The company has established a strategic layout of multiple oncology product pipelines, including one commercialized drug and six clinical stage candidates[4]. - The company is building a professional sales and marketing team to enhance commercialization efforts both domestically and internationally[4]. - The company aims to expand its market presence and product awareness in China by recruiting talent with commercialization skills and leveraging its commercialization team's expertise[20]. - The company anticipates greater business development opportunities for its ADC products due to recognition from multinational companies[20]. - The company is focused on obtaining orphan drug designation (ODD) for its key products[67]. - The company aims to expand its market presence and enhance its product pipeline through strategic partnerships[67]. Financial Position - Cash and cash equivalents as of June 30, 2023, amounted to RMB 581.5 million, with net current liabilities of approximately RMB 155.3 million[46]. - The total salary cost for the group was RMB 89.2 million for the six months ended June 30, 2023, compared to RMB 85.6 million for the same period in 2022, mainly due to an increase in the number of sales and marketing personnel[34]. - The group had capital commitments of RMB 466.2 million for property, plant, and equipment as of June 30, 2023, down from RMB 482.0 million as of December 31, 2022[31]. - The asset-liability ratio increased to 68.24% as of June 30, 2023, compared to 64.39% as of December 31, 2022[30]. - The company’s total equity decreased from RMB 900.8 million at the end of 2022 to RMB 762.2 million by June 30, 2023[42]. - The company’s intangible assets decreased from RMB 450.81 million to RMB 439.99 million[42]. Corporate Governance - The board of directors includes Dr. Pu Zhongjie as chairman and executive director, Dr. Sui Ziyeno as general manager, and Dr. Hu Zhaohong as co-general manager[70]. - The board meeting was held in Shanghai, China on August 25, 2023[70]. Market and Industry - The group primarily operates in China, with all major revenue sources derived from this market[49]. - The company focuses on innovative biotherapies for autoimmune and tumor treatments, established in September 2016[66]. - The company is involved in the research of tissue factor (TF) protein, which is expressed at high levels in many cancer cells[70]. - The company is exploring treatments for triple-negative breast cancer (TNBC) and urothelial carcinoma (UC)[70].

Product Development and Clinical Trials - The company achieved significant progress with its first approved product, Putili Monoclonal Antibody, for MSI-H/dMMR solid tumors and melanoma, which were approved for market in July and September 2022 respectively[7]. - CMG901, a targeted ADC, secured an exclusive licensing agreement with AstraZeneca, resulting in an upfront payment of $63 million and potential additional payments of up to $1.125 billion based on development and regulatory milestones[7]. - The company’s ADC pipeline is entering a harvest phase, with MRG003 for advanced nasopharyngeal carcinoma (NPC) and head and neck squamous cell carcinoma (HNSCC) progressing to registration clinical trials, having received orphan drug designation from the FDA[8]. - MRG002, targeting HER2-positive advanced breast cancer, has completed enrollment for its registration phase II clinical trial, with NDA submission expected in 2023[8]. - Several innovative ADC products are in phase I clinical trials, with early clinical data showing promising efficacy signals, including MRG004A for pancreatic cancer and triple-negative breast cancer[8]. - CG0070, an oncolytic adenovirus for bladder cancer, is currently in a Phase III clinical trial in the US, with a Phase I trial initiated in Greater China[9]. - The company has received IND approval for a clinical trial combining CG0070 with PDR001 for NMIBC patients who failed BCG treatment[9]. - MRG003 achieved an overall response rate (ORR) of 47.4% and a disease control rate (DCR) of 79.0% in the NPC clinical trial, with a median progression-free survival (PFS) of 6.3 months[18]. - MRG002 demonstrated an ORR of 56.1% and a DCR of 87.8% in the UC clinical trial, with a median PFS of 6.4 months as of October 12, 2022[20]. - MRG003 received breakthrough therapy designation for NPC and orphan drug designation from the FDA in September 2022[18]. - MRG002 has been granted orphan drug designation by the FDA for the treatment of GC/GEJ cancer as of August 2022[20]. - The company is conducting multiple ongoing clinical trials for HX008, MRG003, and MRG002 across various indications, including NSCLC and HNSCC[19]. - MRG003 has received FDA orphan drug designation and CDE breakthrough therapy designation, while MRG002 has also received FDA orphan drug designation[14]. - The ADC innovation linker-payload platform has shown potential, with candidate MRG006A entering IND-enabling research[10]. - LP002 has shown good safety and efficacy in clinical trials, with a Phase II study for ES-SCLC completed in July 2022, leading to approval for a Phase III trial based on positive data[22]. - MRG001 is currently undergoing an Ib phase dose expansion study in China, targeting B-cell NHL patients with primary or acquired resistance to rituximab[23]. - CMG901, a CLDN 18.2 targeted ADC, has completed its Phase I dose escalation trial with promising initial data and received FDA fast track and orphan drug designations[24]. Financial Performance and Market Position - The company completed its IPO on February 23, 2022, and was included in the Hang Seng Index series in September 2022, marking a significant recognition in the capital market[6]. - The company recorded revenue of RMB 15.6 million in 2022 due to the successful commercialization of HX008, compared to zero in 2021[34]. - Other income increased from RMB 10.6 million in 2021 to RMB 11.3 million in 2022, primarily due to increased government subsidies[35]. - Sales and marketing expenses were RMB 1.7 million in 2022, reflecting the commercialization efforts for HX008, compared to zero in 2021[36]. - Administrative expenses decreased from RMB 156.2 million in 2021 to RMB 138.8 million in 2022, mainly due to a reduction in share-based payment expenses[37]. - Research and development expenses decreased from RMB 791.2 million in 2021 to RMB 524.3 million in 2022, with significant reductions in clinical trial costs and employee benefits[38]. - The company’s loss decreased from RMB 1,028.9 million in 2021 to RMB 699.4 million in 2022[44]. - Financial income increased significantly from RMB 4.1 million in 2021 to RMB 45.9 million in 2022, mainly due to foreign exchange gains from global fundraising[43]. - The company has a remaining unutilized amount of RMB 509.68 million as of December 31, 2022[55]. - The company plans to enhance commercialization and marketing efforts for its first marketed product, PDR001, to increase market share and sales in China[12]. - The company is focused on expanding its candidate drug pipeline and fulfilling ongoing payment obligations related to the acquisition of HX008[55]. - The company plans to expand its market presence in China and internationally, leveraging its ADC platform recognized by multinational companies[33]. Research and Development Strategy - The company has established a robust ADC technology research and development platform to address unmet clinical needs in cancer treatment[6]. - The company is focused on building its commercialization capabilities to enhance the translation of core technologies into marketable products[6]. - The company emphasizes the uncertainty of successfully developing and commercializing its products, advising caution to shareholders and potential investors[18]. - The company is actively involved in clinical trials and research for its drug candidates, indicating a strong commitment to innovation and market expansion[55]. - The company has a strong commitment to maintaining effective communication with shareholders and investors[181]. - The company has established an advanced systematic ADC technology research and development platform to develop innovative drugs[72]. - The company emphasizes continuous R&D innovation, focusing on differentiated biopharmaceuticals for cancer treatment and adhering to strict regulatory compliance in drug development[198][199]. Corporate Governance and Compliance - The company has a commitment to compliance and governance, with board members holding various legal and regulatory qualifications[64]. - The company has established a risk management and internal control system that is considered to be relatively sound[123]. - The company has implemented environmental, health, and safety policies to ensure compliance with applicable laws and regulations[117]. - The board has adopted corporate governance practices in accordance with the listing rules since the company's H-shares were listed on February 23, 2022[125]. - The company has adopted anti-corruption policies and systems as part of its corporate governance framework[125]. - The company has implemented multiple confidentiality measures for the medical records and personal data of clinical trial participants, including encryption and internal rules for employee confidentiality[164]. - The company has established a comprehensive internal control policy covering procurement, supplier management, R&D, clinical trial registration, and other business processes[168]. - The company has a total of 7 senior management personnel, with 3 earning between RMB 4,000,001 and RMB 5,000,000, and 1 earning over RMB 5,000,001[146]. - The company has established four committees, including the audit committee, remuneration and assessment committee, nomination committee, and strategic committee, to oversee specific areas of governance[149]. - The audit committee is tasked with reviewing the company's financial controls, internal controls, and risk management systems[150]. - The company has a three-member Supervisory Board, including a staff representative, to oversee the board and senior management[158]. - The company has a strong emphasis on clinical research and development, with key personnel having extensive experience in clinical registration and quality management[64]. Shareholder and Market Engagement - The company is preparing for a listing on the Sci-Tech Innovation Board, indicating plans for further market expansion[6]. - The company has made amendments to its articles of association in preparation for the issuance of A-shares and listing on the Shanghai Stock Exchange[182]. - The company will hold its annual general meeting on June 15, 2023, with a suspension of shareholder registration from May 16 to June 15, 2023[120]. - Shareholders holding 10% or more of the company's shares can request a special general meeting within 10 days of their written request[175]. - Shareholders holding 3% or more of the company's shares can propose agenda items for the general meeting 10 days prior to the meeting[176]. - The company has a strong management team with over 20 years of experience in biopharmaceutical research and development, particularly in the field of recombinant proteins and monoclonal antibodies[67]. - The company has a diverse board composition, including independent directors with backgrounds in academia and investment banking, which supports robust governance[62]. ESG and Sustainability Initiatives - The company integrates ESG management principles into daily operations, focusing on stakeholder demands while ensuring shareholder and investor interests are protected[189]. - The company actively responds to national dual carbon strategies, optimizing energy structure to reduce negative environmental impacts and address climate change risks[189]. - The board of directors is responsible for overseeing ESG strategies and performance, with regular evaluations of ESG issues' significance conducted[190]. - The company has identified 14 key ESG issues relevant to its operations, prioritizing them based on their importance to business development and stakeholders[194].

Financial Performance - For the year ended December 31, 2022, the company recorded revenue of approximately RMB 156 million and a gross profit of approximately RMB 136 million[3]. - The loss attributable to owners of the company decreased by approximately 31.8%, from about RMB 1,011 million for the year ended December 31, 2021, to approximately RMB 689.1 million for the year ended December 31, 2022[3]. - The company reported a total comprehensive loss of RMB 699,332 thousand for the year, compared to RMB 1,028,842 thousand in the previous year[39]. - The company's net loss decreased from RMB 1,028.9 million in 2021 to RMB 699.4 million in 2022[29]. - The company reported a basic loss per share of RMB 0.42 for the year ended December 31, 2022, compared to RMB 0.66 for the previous year, indicating a reduction in losses[55]. - The company generated sales revenue of RMB 15.6 million from the product 普佑恆TM (Putili monoclonal antibody injection) by December 31, 2022[15]. - The company recorded revenue of RMB 15.6 million for the year ended December 31, 2022, due to the successful commercialization of HX008, compared to zero in 2021[22]. Research and Development - Research and development expenses decreased by approximately 33.7%, from about RMB 791.2 million for the year ended December 31, 2021, to approximately RMB 524.3 million for the year ended December 31, 2022[3]. - The company is actively developing a differentiated pipeline through internal R&D and strategic collaborations, enhancing its production capabilities[4]. - MRG003 received FDA orphan drug designation and breakthrough therapy designation, with ongoing clinical trials showing promising data[2]. - MRG002 is in the registration study phase for HER2-overexpressing breast cancer, with NDA submission expected in 2023[3]. - The company is conducting a Phase III clinical trial for HX008 in combination with irinotecan for GC/GEJ second-line treatment, currently enrolling patients[7]. - MRG003 has been granted breakthrough therapy designation by CDE for NPC treatment, and has also received orphan drug status from the FDA[9]. - The company is focusing on clinical research for MRG003 in HNSCC, with Phase III clinical trial approval obtained in October 2022[8]. - The company is advancing multiple Phase II clinical trials for HX008 in NSCLC, TNBC, and HCC[7]. - MRG002 has received orphan drug designation from the FDA for the treatment of GC/GEJ cancer, with ongoing Phase II clinical trials for HER2-overexpressing breast cancer[10]. - The company has initiated a Phase II clinical trial for LP002 in combination with carboplatin and etoposide for ES-SCLC, with good preliminary data observed[12]. Strategic Partnerships and Collaborations - The company has established a global exclusive licensing agreement with AstraZeneca for CMG901, enhancing its strategic partnerships[6]. - A global exclusive licensing agreement was signed with AstraZeneca for CMG901, with an upfront payment of USD 63 million and potential additional payments of up to USD 1.125 billion[18]. - The company is actively pursuing the development of ADCs targeting various cancers, with several candidates in different clinical stages[5]. - The company is exploring potential acquisitions to enhance its product pipeline, with a budget of up to RMB 1 billion allocated for this purpose[68]. Market Presence and Future Outlook - The company plans to expand its market presence in Southeast Asia, targeting a revenue contribution of 10% from this region by 2025[67]. - The company anticipates a 30% increase in market share for its core products in the next fiscal year, driven by new product launches and expanded distribution channels[68]. - The company has set a performance guidance of 20% revenue growth for the next fiscal year, supported by ongoing clinical trials and product approvals[71]. - The company is expanding its market presence in China and plans to enhance its commercialization team to improve product awareness[21]. Operational Efficiency - Administrative expenses decreased by approximately 11.1%, from about RMB 156.2 million for the year ended December 31, 2021, to approximately RMB 138.8 million for the year ended December 31, 2022[3]. - Clinical trial and pharmaceutical research expenses decreased by RMB 134.5 million, primarily due to resource prioritization on the most promising drug candidates and indications[27]. - Employee benefits expenses decreased by RMB 41.2 million, mainly due to a reduction in share-based payment expenses[27]. - Preclinical research costs decreased by RMB 65.6 million, as some drug candidates entered clinical research stages[27]. - The total expenses for sales cost, sales and marketing, administrative, and research and development amounted to RMB 667,598 thousand in 2022, down from RMB 948,521 thousand in 2021, reflecting a reduction of 29.5%[50]. Financial Position - Cash and cash equivalents increased to RMB 669.4 million as of December 31, 2022, up RMB 514.2 million from RMB 155.2 million as of December 31, 2021[29]. - The debt-to-asset ratio increased to 64.39% as of December 31, 2022, compared to 59.32% as of December 31, 2021[31]. - The company raised approximately HKD 882.5 million from the global offering, net of listing expenses[30]. - As of December 31, 2022, the company had bank borrowings totaling RMB 650.0 million, with RMB 329.6 million being unsecured loans[30]. - The company has cash and cash equivalents of approximately RMB 669.4 million as of December 31, 2022, indicating sufficient liquidity for at least the next twelve months[44]. Corporate Governance - The company is a non-wholly owned subsidiary established on November 25, 2016, in China[72]. - The board of directors includes Dr. Pu Zhongjie as Chairman and Executive Director, and Dr. Sui Ziyeno as General Manager[72]. - The board includes both executive and non-executive directors, ensuring diverse governance[72].