Financial Performance - Jiangsu Qunxin Biopharmaceutical Co., Ltd. achieved a revenue of approximately RMB 158.8 million in 2024, marking a significant increase compared to 2023[14]. - The company reported a net loss of RMB 349.7 million for the year, an improvement from a loss of RMB 521.3 million in 2023, indicating a reduction in losses by approximately 32.9%[14]. - Cash and cash equivalents increased by 47.6% to RMB 556.1 million, up from RMB 376.7 million in 2023, reflecting a strong liquidity position[14]. - The adjusted net loss under non-IFRS measures was RMB 274.2 million, down from RMB 390.0 million in 2023, indicating improved operational efficiency[14]. - For the fiscal year ending December 31, 2024, the company's revenue was RMB 158.8 million, primarily from licensing fees of RMB 100.9 million from QX008N and QX004N, and RMB 55.7 million from R&D and CDMO services[15]. - The company's CDMO service revenue increased from RMB 12.1 million in 2023 to RMB 23.8 million in 2024, reflecting a growth of RMB 11.7 million[15]. - The cost of sales for the fiscal year ending December 31, 2024, was RMB 66.6 million, which includes costs associated with R&D services for QX004N and QX008N, as well as CDMO services[16]. - The company achieved a gross profit of RMB 92.2 million for the fiscal year ending December 31, 2024, with a gross margin reflecting strong R&D capabilities[55]. - The company's total employee costs, including director remuneration, amounted to approximately RMB 168.8 million for the year ending December 31, 2024, a decrease from RMB 222.4 million for the previous year[51]. - Administrative expenses decreased significantly from RMB 164.6 million in 2023 to RMB 115.9 million in 2024, mainly due to a reduction in equity-settled share payment expenses[61]. - Other income increased by 15.63% from RMB 24.9 million in 2023 to RMB 28.8 million in 2024, driven by government subsidies and interest income[59]. - Financial costs rose by 39.3% to RMB 23.4 million in 2024, attributed to increased bank borrowings to meet operational needs[63]. - The company recorded a net loss of RMB 349.7 million for the year ending December 31, 2024, an improvement of 33% compared to a net loss of RMB 521.3 million in 2023[64]. - The company has generated significant operating losses since its inception and expects to continue incurring losses for the foreseeable future[164]. Research and Development - The company’s R&D expenses decreased to RMB 334.3 million from RMB 364.4 million in the previous year, showing a focus on cost management[14]. - R&D expenses decreased by 8.3% from RMB 364.4 million in 2023 to RMB 334.3 million in 2024, mainly due to reclassification of clinical costs and a reduction in equity-settled share payment expenses[17]. - The total R&D costs for the year ended December 31, 2024, amounted to approximately RMB 334.3 million, a decrease from RMB 364.4 million in 2023[46][47]. - The company has achieved 20 IND approvals over the past 9 years, with 19 from the National Medical Products Administration and 1 from the FDA[45]. - QX002N for AS is progressing to Phase III clinical trial, with primary endpoint data expected in February 2025[27]. - QX005N for adult moderate-to-severe AD and PN has initiated Phase III trials, with first patient in (FPI) achieved in May 2024[27]. - QX001S received drug registration certificate from the National Medical Products Administration in October 2024, branded as "Sailuxin®"[27]. - QX004N completed Phase II primary endpoint data readout in August 2024, with further clinical trial plans announced[27]. - QX006N for SLE completed Phase Ib clinical trial as of the last feasible date[27]. - QX005N has received IND approvals for seven indications, including adult and adolescent moderate-to-severe AD, PN, and asthma[28]. - QX013N for CSU achieved the last patient in (LPI) for Phase I clinical trial in September 2024[27]. - The company has established a collaboration agreement with East China Pharmaceutical for the development and commercialization of QX001S in China[27]. - QX008N is under development for COPD in China, with Health元 leading the clinical trials[27]. - The company retains exclusive rights for QX001S outside of China, while collaborating with East China Pharmaceutical for its commercialization[27]. - QX005N was included in the Breakthrough Therapy Designation (BTD) list in January 2024, indicating superior clinical efficacy compared to current treatments[29]. - The Phase II clinical trial for QX005N in treating CRSwNP was completed in February 2025, with a collaboration agreement established with China Meheco in July 2024 for joint development[30]. - The Phase III clinical trial for QX002N in treating AS enrolled 641 patients, with a 40.4% ASAS40 response rate in the treatment group compared to 18.9% in the placebo group (P<0.0001)[32]. - QX001S, a biosimilar to ustekinumab, was approved in October 2024, with global sales of Stelara® reaching $10.361 billion in 2024[34]. - China Meheco submitted a BLA for QX001S in July 2023, which was approved in October 2024, and additional applications for pediatric indications are underway[35]. - QX004N showed a 76.9% improvement in PASI scores after 16 weeks of treatment in the Phase II trial, indicating strong efficacy[37]. - QX008N completed its Phase Ib clinical trial for moderate to severe asthma in January 2025, with a licensing agreement signed with Health元 for development in specific regions[39]. - QX013N received clinical trial approval from the National Medical Products Administration for the treatment of CSU on May 9, 2024, marking it as the first c-kit targeted candidate biologic in China[40]. - QX006N, an IFNAR1 targeted monoclonal antibody for SLE, successfully completed its Ib phase clinical trial in October 2024[43]. Strategic Collaborations and Partnerships - Strategic collaborations with major pharmaceutical companies were established to enhance clinical research and commercialization potential, including partnerships for QX008N and QX004N[9]. - The company entered into a strategic collaboration with Health Yuan for the development and commercialization of QX008N, receiving an upfront payment of RMB 75.0 million[20]. - A collaboration agreement was established with Han Sen (Shanghai) for QX004N, which includes potential milestone payments of up to RMB 1,032.0 million[21]. - The company will share the costs of the Phase III clinical trial for QX005N with China Medical East on a 50/50 basis, enhancing its commercialization potential[22]. - The company has a strategic focus on product licensing and mergers and acquisitions, as highlighted by Mr. Yu's previous role in business development at Heplisav-B[113]. - The company aims to enhance its market presence through strategic partnerships and collaborations in the biopharmaceutical sector[117]. Market and Operational Strategies - Future strategies will focus on maintaining clinical progress of existing products and expanding into domestic and international markets for innovative drugs[11]. - The company plans to strengthen its core competitive advantages by expanding its pipeline and seeking overseas opportunities[52][53]. - The company aims to enhance production efficiency and capacity utilization while continuing to recruit and develop talent[53]. - The company has a mission to address the vast unmet medical needs in the autoimmune and allergic disease market through its innovative therapies[157]. - The company has a strong focus on expanding its market presence and enhancing its product development capabilities[157]. - The company is positioned for future growth with a focus on innovation and market expansion, supported by its experienced leadership team[123]. Governance and Management - The board currently consists of three executive directors, two non-executive directors, and three independent non-executive directors[155]. - The independent directors are tasked with providing oversight and strategic guidance, ensuring the company's governance aligns with best practices[121][126]. - The management team emphasizes the importance of financial reporting and analysis in driving business decisions and strategies[110]. - The company is committed to ensuring no actual conflicts of interest exist between its directors and stakeholders[116]. - The company has a diverse board with members experienced in finance, investment management, and biopharmaceuticals, enhancing its strategic oversight[136]. - The management team has a diverse background in pharmaceuticals, biotechnology, and clinical research, contributing to strategic growth[142]. Risks and Compliance - The company faces significant risks related to its financial condition, drug development, clinical trials, and regulatory approvals, with no guarantee of successfully commercializing its core products[163]. - The company is committed to maintaining compliance with environmental protection and occupational health and safety regulations in China[166]. - The group regularly monitors liquidity needs and adheres to borrowing covenants to maintain sufficient cash reserves[87]. - The group conducts impairment assessments based on expected credit loss models to ensure adequate provisions for credit losses[86]. Employee and Operational Metrics - As of December 31, 2024, the company employed 339 staff members, all located in China, and is focused on providing a safe working environment[171]. - The internal R&D team consists of 125 members, with approximately 59% holding master's degrees or higher in relevant fields[45]. - The production facility has passed GMP compliance inspection by the National Medical Products Administration in November 2024, ensuring adherence to quality standards[48]. - The production facility has a therapeutic antibody production capacity of approximately 300 kg per year, with specific production lines for vials and pre-filled syringes[48]. Financial Position and Investments - Current assets increased from RMB 418.3 million in 2023 to RMB 616.7 million in 2024, reflecting a significant growth in liquidity[66]. - Trade and other receivables surged by 95.8% from RMB 26.5 million in 2023 to RMB 51.8 million in 2024, driven by increased receivables from licensing agreements[71]. - Non-current liabilities rose by 37.0% from RMB 242.9 million in 2023 to RMB 332.7 million in 2024, mainly due to an increase in bank loans with a term of 2 to 3 years[69]. - The company's operating cash flow improved, with net cash used in operating activities decreasing from RMB 300.7 million in 2023 to RMB 186.1 million in 2024[76]. - Financing activities generated net cash of RMB 351.8 million in 2024, a significant increase from RMB 61.2 million in 2023, largely due to IPO proceeds and increased bank borrowings[77]. - The current ratio decreased from 1.7 in 2023 to 1.4 in 2024, attributed to rising current liabilities associated with ongoing clinical trials[82]. - The debt-to-asset ratio increased from 42.5% in 2023 to 74.7% in 2024, primarily due to higher bank borrowings[83]. - The company has an unused credit line of RMB 161.7 million available for working capital as of December 31, 2024[75]. - The group has implemented a cautious investment strategy, focusing on low-risk financial products provided by reputable banks[96].

Company and Industry Summary Company Overview - The company, 全信生物 (Quanxin Bio), specializes in the field of autoimmune diseases and has been innovating in drug development for nearly a decade, focusing on monoclonal antibodies and bispecific antibodies [1][3]. Key Points and Arguments Innovation and R&D - The company emphasizes its strong capability for continuous innovation and R&D, with all products being developed in-house [1]. - It has established a GMP-certified production facility to ensure product supply and support the development of innovative antibodies [1]. Market Position and Strategy - Management views the company as having strong certainty in both R&D and commercial aspects, aiming to maximize product value in the market [2]. - The company is focusing on four main therapeutic areas: dermatology, rheumatology, respiratory, and digestive diseases, with dermatology being the core area [2]. Product Pipeline and Development - The company expects to complete Phase III trials for its VGF product within the year and has initiated a second round of development [3]. - In 2024, the company plans to launch its first product, 乌斯乌丹康 (Usumudan), which has already been approved and is being promoted nationwide [4]. Financial Performance - The company reported significant revenue growth, with a target of 300 million yuan for sales and a peak sales expectation of 1.5 to 2 billion yuan for its products [8]. - The financial outlook is positive, with a nearly 50% increase in cash reserves compared to the previous year [23]. Collaborations and Partnerships - The company has partnered with 华东医药 (East China Pharmaceutical) to leverage its strong sales channels in the domestic autoimmune market [8][9]. - The collaboration is expected to enhance patient management and drive sales growth for the company's products [9]. Competitive Landscape - The company acknowledges the competitive landscape in the autoimmune drug market, with several players developing similar products [12]. - However, it believes that effective commercialization strategies will be crucial for success in this rapidly growing market [12]. Future Outlook - The company plans to expand its product offerings in the respiratory disease market, which is seen as a significant growth opportunity [6]. - It aims to diversify its commercial partnerships and explore international markets for its innovative products [25]. Additional Important Information - The company has a robust pipeline with multiple products in various stages of development, including several bispecific antibodies targeting different diseases [41][45]. - The management is optimistic about the potential for significant revenue generation from its CDMO (Contract Development and Manufacturing Organization) business, which has already secured substantial external orders [20][48]. - The company is focused on maintaining a strong financial position to support its R&D and operational needs over the next few years [53]. This summary encapsulates the key aspects of the company's operations, market strategy, financial performance, and future outlook, providing a comprehensive overview of its current status and potential in the industry.

Financial Performance - For the fiscal year ending December 31, 2024, the company reported revenue of RMB 158.8 million, primarily from licensing fees of RMB 100.9 million related to QX008N and QX004N, and RMB 55.7 million from R&D and CDMO services[6]. - The cost of sales for the same period was RMB 66.6 million, which includes costs associated with R&D services for QX004N and QX008N, as well as CDMO services[7]. - The net loss for the year was RMB 349.7 million, a 33% improvement from RMB 521.3 million in 2023[10]. - Adjusted net loss, excluding certain non-cash items, was RMB 274.2 million, down 30% from RMB 390.0 million in the previous year[10]. - Cash and cash equivalents increased to RMB 556.1 million from RMB 376.7 million in 2023[4]. - Other income increased by 15.63% from RMB 24.9 million in 2023 to RMB 28.8 million in 2024, primarily due to government subsidies and interest income[53]. - Administrative expenses decreased from RMB 164.6 million in 2023 to RMB 115.9 million in 2024, mainly due to a reduction in equity-settled share payment expenses[55]. - Financial costs increased by 39.3% from RMB 16.8 million in 2023 to RMB 23.4 million in 2024, primarily due to increased bank borrowings[58]. - The company reported a total revenue of RMB 158.8 million for the year ending December 31, 2024, compared to no revenue in 2023[112]. - Gross profit for the same period was RMB 92.2 million, with a cost of sales amounting to RMB 66.6 million[112]. - The operating loss decreased to RMB 326.4 million in 2024 from RMB 504.5 million in 2023, indicating an improvement in operational efficiency[112]. - Cash used in operating activities decreased to RMB 186.1 million in 2024 from RMB 300.7 million in 2023, attributed to revenue from licensing agreements and milestone payments[66]. - Cash generated from financing activities increased significantly to RMB 351.8 million in 2024 from RMB 61.2 million in 2023, driven by proceeds from the initial public offering and increased bank loans[67]. Research and Development - R&D expenses decreased by 8.3% from RMB 364.4 million in 2023 to RMB 334.3 million in 2024, mainly due to reclassification of clinical costs and a reduction in equity-settled share payment expenses[8]. - The total R&D costs for the year ended December 31, 2024, amounted to approximately RMB 334.3 million, a decrease from RMB 364.4 million in 2023[38]. - Employee costs for R&D were RMB 66.99 million in 2024, down from RMB 92.99 million in 2023[39]. - The product pipeline includes QX002N and QX005N, with QX002N achieving primary endpoints in a Phase III trial for ankylosing spondylitis[11]. - QX001S, a treatment for psoriasis, received drug registration approval in October 2024, becoming the first biosimilar of ustekinumab in China[11]. - QX005N for adult moderate to severe atopic dermatitis (AD) achieved first patient in (FPI) in May 2024, with Phase III trial completion expected by March 2025[18]. - QX005N for adolescent AD entered Phase Ib/IIa trial with FPI achieved in June 2024[18]. - QX001S received drug registration certificate approval from the National Medical Products Administration in October 2024, branded as "Sailuxin®"[18]. - QX004N's Phase II clinical data was disclosed at the American Academy of Dermatology annual meeting in March 2025[18]. - QX013N for chronic spontaneous urticaria (CSU) completed Phase Ia trial with FPI achieved in June 2024[18]. - QX006N for systemic lupus erythematosus (SLE) is currently in Phase Ib trial[18]. - QX008N is undergoing Phase II clinical trials for chronic obstructive pulmonary disease (COPD) in China[18]. - QX005N has received IND approvals for seven indications, including adult and adolescent AD, prurigo nodularis (PN), chronic rhinosinusitis with nasal polyps (CRSwNP), CSU, asthma, and COPD[19]. - QX005N was included in the Breakthrough Therapy Designation (BTD) list in January 2024, indicating superior clinical efficacy compared to current treatment methods[20]. - The Phase III trial for QX002N enrolled 641 patients, with a 40.4% ASAS40 response rate in the treatment group compared to 18.9% in the placebo group (P < 0.0001)[24]. - The company is focused on the research and development of biotherapies for autoimmune and allergic diseases, indicating a strategic emphasis on innovation and market expansion[120]. Strategic Partnerships and Collaborations - The company has successfully developed strategic partnerships for core products, including a technology transfer agreement for QX008N with Health元 and an exclusive licensing agreement for QX004N with 翰森[12][13]. - Company entered into a collaboration agreement with China Medical East to co-develop QX005N, sharing 50% of the Phase III clinical trial costs[14]. - The collaboration with China Meheco involves sharing 50% of the Phase III clinical trial costs for QX005N, enhancing its commercialization potential[21]. - The company has entered into a cooperation agreement with East China Pharmaceutical for the joint development and commercialization of QX005N, dated July 19, 2024[158]. - The company plans to leverage strong medical resources and networks from well-known pharmaceutical companies for future commercialization of its candidate drugs[42]. Corporate Governance and Compliance - The audit committee has reviewed the financial reporting procedures and internal control systems, ensuring compliance with the corporate governance code[101]. - The company is committed to enhancing its corporate governance practices to promote business growth and ensure compliance with the latest developments[94]. - The company has a diverse and experienced board, ensuring a balance of power and authority[93]. - The board of directors has confirmed compliance with the standard code of conduct for securities trading since the listing date, with no violations reported during the reporting period[92]. Market Position and Future Plans - The company plans to strengthen its core competitive advantages and explore overseas expansion opportunities as part of its future strategy[46]. - The company plans to expand QX001S for pediatric plaque psoriasis and Crohn's disease following its approval for adult indications[27]. - The company is exploring strategic partnerships and potential acquisitions to enhance its market position and expand its product offerings[165]. - The company has established a production facility compliant with cGMP standards, with an annual production capacity of approximately 300 kg of therapeutic antibodies[41]. - The production facility includes a production line for vials with a capacity of 18,000 bottles per hour and a pre-filled syringe line with a capacity of 9,000 units per hour[41]. Financial Position and Assets - Total current assets increased to RMB 616.7 million in 2024 from RMB 418.3 million in 2023, while total liabilities rose to RMB 762.8 million from RMB 494.6 million[61]. - Non-current liabilities increased by 37% to RMB 332.7 million in 2024, primarily due to an increase in bank loans with a term of 2 to 3 years[63]. - The current ratio declined to 1.4 in 2024 from 1.7 in 2023, mainly due to increased current liabilities associated with clinical trials[72]. - The debt-to-asset ratio rose to 74.7% in 2024 from 42.5% in 2023, primarily due to increased borrowings[73]. - The company has secured additional credit financing of RMB 30.0 million post-reporting period, indicating no significant difficulties in obtaining further credit[69]. - The company’s total assets decreased, with net asset value reported at RMB 221,050 thousand in 2024 compared to RMB 300,950 thousand in 2023[116]. - The company’s total trade and other payables reached RMB 208,794 thousand in 2024, up from RMB 129,914 thousand in 2023, reflecting a growth of 60.6%[146]. Risk Management - The group faces currency risk primarily from cash balances denominated in currencies other than the functional currency, specifically HKD and USD[80]. - The group regularly monitors liquidity needs and adheres to borrowing covenants to maintain sufficient cash reserves[78]. - The group conducts impairment assessments based on expected credit loss models to ensure adequate provisions for credit losses[77]. - The group has implemented a cautious investment strategy, focusing on low-risk financial products provided by reputable banks[85]. - The group does not utilize any interest rate swaps to hedge against interest rate risks as of December 31, 2024[79]. Shareholder Information - The company has a significant shareholder structure, with Mr. Qiu holding approximately 45.71% through Shanghai Quan You Investment Management Partnership[165]. - The company has not declared or paid any dividends for the year ending December 31, 2024, consistent with 2023[152]. - The company has not conducted any share buybacks or sales since the listing date[89].

Summary of the Conference Call Company and Industry Overview - The conference call focused on the biotechnology industry, specifically highlighting the company Quanxin Biotechnology and its developments in the field of immunology and monoclonal antibodies [1][2]. Key Points and Arguments 1. **Market Potential**: The company believes there is a significant market for self-media in China, which remains largely untapped despite the presence of numerous oncology companies [2]. 2. **Product Development**: Continuous development of monoclonal and bispecific antibodies is planned, ensuring a steady pipeline of products [3]. 3. **Sales Strategy**: The company has adopted a strategy of collaborating with leading companies in the field to enhance product commercialization, rather than building its own sales team [4]. 4. **Product Pipeline**: The company has a diverse pipeline with over a hundred types of monoclonal antibodies, focusing on four main areas, with a current emphasis on the development of specific products [6]. 5. **Financial Performance**: The company reported a cash inflow of approximately 1.7 billion RMB in 2024 through business development (BD) efforts, with expectations of at least 1 billion RMB in 2025 [9]. 6. **Key Products**: The company is advancing two core products, both in Phase III trials, and has plans for commercialization in the near future [10]. 7. **Market Positioning**: The company aims to capture market share from existing products by offering competitive pricing and unique therapeutic benefits [21][24]. 8. **Sales Projections**: The company anticipates that one of its products could achieve sales of 300 million RMB by 2025, with peak sales projected between 1.5 to 2 billion RMB [18]. 9. **Collaboration with Partners**: The company is working with partners like Huadong to manage product sales effectively, which is crucial for ensuring strong market penetration [19]. 10. **Cash Flow Management**: The company is managing its cash flow carefully, with a current cash position of 650 million RMB, and is planning for potential pressures on cash due to high operational costs [46]. Additional Important Insights - **Regulatory Environment**: The company is navigating the regulatory landscape for its products, with plans to submit applications for new indications without needing extensive additional clinical trials [54]. - **Competitive Landscape**: The company is aware of the competitive pressures in the market, particularly from established players, and is focusing on differentiation through innovative product offerings [52]. - **Future Developments**: The company is optimistic about its future product launches and collaborations, which are expected to enhance its market presence and financial stability [49][56]. This summary encapsulates the key discussions and insights from the conference call, providing a comprehensive overview of the company's strategic direction and market positioning within the biotechnology industry.