Zelgen(SH:688266)2021-04-28 16:00Financial Performance - As of December 31, 2020, the company has not yet achieved profitability and has accumulated losses due to significant R&D expenditures[5] - The company raised a net amount of RMB 1,908.22 million during its IPO on the STAR Market in January 2020[5] - The company does not plan to distribute cash dividends or issue bonus shares for the 2020 fiscal year[7] - The company's operating revenue for 2020 was CNY 27,660,909.30, a significant increase from CNY 1,311,158.07 in 2018[29] - The net loss attributable to shareholders for 2020 was CNY -319,229,251.52, an improvement compared to CNY -461,877,238.60 in 2019[29] - The net cash flow from operating activities was CNY -343,856,869.25 in 2020, compared to CNY -180,427,947.30 in 2019[31] - The total assets at the end of 2020 were CNY 1,970,281,983.90, a 515.20% increase from CNY 320,268,087.69 in 2019[31] - The net assets attributable to shareholders at the end of 2020 were CNY 1,617,725,382.28, a significant increase from CNY 3,426,155.64 in 2019[31] - The basic earnings per share for 2020 was CNY -1.36, an improvement from CNY -2.57 in 2019[32] - The net loss attributable to shareholders after deducting non-recurring gains and losses was CNY -354,674,702.82 in 2020, compared to CNY -271,744,594.58 in 2019[32] - The company reported a significant increase in total assets and net assets due to the funds raised from the public offering of new shares[33] - The company experienced an increase in net loss due to expanded operations, increased R&D investment, and pre-listing expenses[33] - The company has not declared any cash dividends, which may negatively impact shareholder returns[5] - The company achieved revenue of CNY 27.66 million during the reporting period, primarily from licensing income of antibody products and minimal R&D service income, compared to zero revenue in the same period last year[131] - R&D investment increased by 70.91% year-on-year to CNY 314.20 million, reflecting the company's commitment to advancing its product pipeline[133] Research and Development - The company is still in the product development stage and has not received commercial sales approval for any drugs, resulting in no sales revenue[5] - Future losses will depend on the number and scope of drug development projects, associated costs, and the ability to generate revenue from approved products[5] - The R&D expenditure as a percentage of operating revenue was 1,135.89% in 2020, indicating a strong focus on research and development[32] - The company has 13 major drug candidates in its pipeline, with 4 in NDA or Phase III clinical trials[46] - The company has established two core technology platforms for drug development: precision small molecule drugs and complex recombinant protein biologics[46] - The company has a dual-target antibody technology platform under development, which is part of its innovation strategy[103] - The company is developing multiple new drug candidates, including ZG5266 for primary biliary cholangitis and non-alcoholic fatty liver disease, currently in Phase I clinical trial preparation[195] - The company is actively pursuing regulatory approvals for its drug candidates, with a focus on ensuring compliance and addressing feedback from regulatory bodies[196] - The company has established a complete technical system for deuterated drug development, achieving a competitive advantage at an international level[95] - The company has successfully filled domestic gaps in complex recombinant protein drugs, establishing a unique competitive advantage[95] Clinical Trials and Drug Development - The drug Donafenib is currently in the NDA stage, while Jakafi is in Phase III clinical trials for high-risk myelofibrosis[46] - The clinical trial for donafenib in treating advanced colorectal cancer has completed patient enrollment and is currently in the data cleaning and quality control phase [50] - The clinical trial for donafenib in treating iodine-refractory differentiated thyroid cancer has completed enrollment and is in the observation and follow-up phase, with a planned interim analysis upcoming [50] - The clinical trial for the small molecule JAK inhibitor, Jackatinib, in treating high-risk myelofibrosis has shown a 51.9% efficacy rate in reducing spleen volume by ≥35% after 24 weeks, significantly outperforming the historical data of 27% for the imported drug ruxolitinib [51] - Jackatinib has received orphan drug designation from the FDA for the treatment of myelofibrosis and has obtained clinical trial approval from the FDA [53] - The external recombinant human thrombin is currently in phase III clinical trials for the treatment of capillary and small vein bleeding [54] - The injectable recombinant human thyroid-stimulating hormone has shown significant advantages in rapidly elevating TSH levels for diagnostic purposes compared to traditional methods, with a median time of 23 days to reach TSH ≥30 mIU/L [55] - The company is conducting Phase III clinical trials for Donafenib in colorectal cancer and thyroid cancer, both of which have completed clinical trials[111] - The company has ongoing projects for Jackatinib in the treatment of myelofibrosis, currently in Phase III clinical trials[111] - The company has several ongoing clinical trials, including Jackatinib for moderate to severe atopic dermatitis in Phase I/II and recombinant human coagulation factor for dermatitis in Phase III[195] Market and Competitive Landscape - The global pharmaceutical market grew from $1.1 trillion in 2015 to $1.3 trillion in 2019, with projections to reach $1.6 trillion by 2024[72] - The Chinese pharmaceutical market grew from CNY 4.1 trillion in 2015 to CNY 6.5 trillion in 2019, with a projected growth to CNY 2.2 trillion by 2024[74] - The company faces significant competition in the innovative drug development space, with potential risks from rapid technological advancements and competitor breakthroughs[143] - The competitive landscape for innovative drug development is intensifying, necessitating the company to actively engage in global competition and adapt to rapid technological changes[94] - The company is strategically positioning itself for market expansion through new product development and potential acquisitions[195] Risks and Challenges - The company faces potential risks related to the inability to complete clinical trials or obtain regulatory approvals for its drug candidates[5] - The company relies on external financing for its working capital, which may pressure its financial condition if expenses exceed available funding[5] - The company is exposed to regulatory risks due to the high level of oversight in the pharmaceutical industry, which could impact its operations if it fails to adapt to policy changes[149] - The ongoing COVID-19 pandemic poses a risk to the company's operations and could lead to economic stagnation[150] - The company’s future profitability may be affected by high R&D costs and the potential for ongoing losses if drug commercialization does not meet expectations[142] Human Resources and Operations - The core team consists of 221 R&D personnel, a 64.93% increase year-on-year, including 9 new PhDs recruited in 2020[65] - The company has reported a significant increase in R&D personnel from 134 to 221, indicating a focus on expanding its research capabilities[123] - The company has established a marketing and business team with over 10 years of experience in drug marketing, particularly in oncology[65] - The company has built three production workshops compliant with GMP standards, preparing for clinical trial drug production and future commercialization[64] - The company has established standardized operating procedures for procurement, including procurement standards and supplier management, to control costs and improve efficiency[69] Strategic Collaborations and Partnerships - The company has established strategic collaborations with multiple pharmaceutical companies to conduct clinical studies on combination therapies for advanced solid tumors, aiming to expand market opportunities[81] - The company has entered into a strategic cooperation with Shanghai Jikai Gene Technology for the development of innovative antibody drugs targeting three selected innovative targets[98] - The company has established a clinical cooperation system with top clinical experts and well-known medical institutions, ensuring high-quality clinical trial operations[129]