Financial Performance - For the six months ended June 30, 2019, the company reported a revenue of RMB 0 thousand, indicating no revenue generation during this period [20]. - The operating loss for the same period was RMB 88,586 thousand, an increase of 71.8% compared to the previous year's loss of RMB 51,557 thousand [20]. - The loss before income tax was RMB 69,677 thousand, which is a 35.3% increase from RMB 51,481 thousand in the prior year [20]. - The total comprehensive loss for the period was RMB 69,677 thousand, reflecting the same percentage increase as the loss before income tax [20]. - The basic and diluted loss per share was RMB 0.38, which is an increase of 11.8% from RMB 0.34 in the previous year [20]. - The company reported a net loss of RMB 69.68 million for the first half of 2019, compared to a loss of RMB 51.48 million in the same period of 2018, representing a 35.3% increase in losses year-over-year [84]. - The company reported a gross operating loss of RMB 88.59 million for the first half of 2019, compared to a loss of RMB 51.56 million in the same period of 2018 [84]. - Other income decreased to RMB 5.39 million in 2019 from RMB 9.96 million in 2018, a decline of 46.1% [84]. - Financial income increased significantly to RMB 19.41 million in 2019 from RMB 0.12 million in 2018 [84]. - The company reported a cumulative loss of RMB (280,965) thousand as of June 30, 2019, compared to RMB (211,288) thousand in the previous year [87]. Research and Development - The company is developing 15 vaccine candidates across 12 disease areas, with three nearing commercialization [21]. - Six vaccine candidates are currently in clinical trial phases, while six others are in preclinical development, including a combined vaccine [21]. - The company's mission focuses on developing high-quality, innovative, and affordable vaccines to meet unmet medical needs in China [21]. - The product pipeline includes potential global innovative vaccines and vaccines aimed at replacing existing mainstream vaccines in China [21]. - The company has not yet commercialized any products and cannot guarantee successful development and commercialization of its vaccine candidates [21]. - The company plans to submit new drug applications for its vaccine candidates by the end of 2019 [153]. - CanSino Biologics has established partnerships with several international organizations to facilitate research and development of new vaccines [153]. - The company has allocated RMB 300 million for research and development in 2019, which is a 15% increase compared to the previous year [153]. Vaccine Development and Trials - PCV13i clinical trial application approved on April 19, 2019, aimed to compete with the world-class PCV13 product for children under 2 years old [24]. - MCV4 new drug application pre-meeting submitted to the National Medical Products Administration on July 5, 2019, potentially being the first MCV4 new drug application in China [24]. - MCV4 demonstrated good safety and immunogenicity in children aged 3 months to 6 years, covering a broader range of serogroups compared to existing products [24]. - The company completed the III phase clinical trial for MCV4 and expects to submit the new drug application soon based on the response from the National Medical Products Administration [25]. - The company anticipates conducting pre-licensing inspections for MCV4 in 2020, followed by its market launch [25]. - The in-development MCV2 vaccine shows better safety and immunogenicity in the 6 to 23 months age group compared to existing MCV2 products in China [26]. - The company is developing a DTcP vaccine for infants, which includes three pertussis antigens for better protection compared to existing products [29]. - The in-development DTcP booster vaccine is expected to complete all clinical trials by 2020 or earlier, being the first of its kind in China [30]. - The company is developing a Tdcp vaccine for adolescents and adults, which is expected to compete with world-class vaccines like Boostrix and Adacel [31]. - The company is developing an innovative tuberculosis booster vaccine, with the Phase I clinical trial showing good safety and tolerance [32]. - The company aims to launch Phase I clinical trials for the improved PCV13i vaccine by the end of 2019 and Phase III trials in 2020, with a new drug application expected in 2024 [33]. Financial Position and Assets - Total assets as of June 30, 2019, amounted to RMB 1,849,823 thousand, a significant increase from RMB 795,875 thousand in the previous year [87]. - Non-current assets totaled RMB 920,654 thousand, compared to RMB 574,871 thousand in the previous year, indicating a growth of approximately 60% [87]. - Current assets reached RMB 929,169 thousand, up from RMB 221,004 thousand, representing an increase of about 320% [87]. - The total equity attributable to owners was RMB 1,560,740 thousand, a rise from RMB 502,317 thousand, reflecting a growth of approximately 210% [87]. - The company raised RMB 1,127,770 thousand from issuing shares during the financing activities, a substantial increase from RMB 17,486 thousand in the previous year [92]. - The company maintained a net cash position as of June 30, 2019, making the debt-to-equity ratio not applicable [58]. - The company reported accounts payable of RMB 56,809,000 as of June 30, 2019, down from RMB 98,509,000 as of December 31, 2018 [141]. Corporate Governance and Compliance - The company is committed to high standards of corporate governance to protect shareholder interests and enhance corporate value [61]. - The independent auditor has reviewed the interim financial data in accordance with the relevant standards, affirming compliance with applicable accounting standards and regulations [20]. - The company has adopted the standard code for securities trading by its directors and supervisors, confirming compliance since the listing date [20]. - The audit committee has discussed the company's internal controls and financial reporting matters with management and the independent auditor [20]. - The company has confirmed that there are no undisclosed interests or short positions held by directors or senior management in the company's shares [70]. Employee and Shareholder Information - As of June 30, 2019, the company had 369 employees, with approximately 78% holding a bachelor's degree or higher [38]. - The total number of shares issued increased to 222,649,899 as of June 30, 2019, from 160,950,899 as of January 1, 2019, reflecting a growth of 38.34% [130]. - The company completed its employee stock ownership plan, with 2,931,941 shares being unlocked and vested as of March 28, 2019 [132]. - The total cumulative expense recognized for share-based payments was RMB 20,156,000 as of June 30, 2019, compared to RMB 33,089,000 as of December 31, 2018 [136].
康希诺生物(06185) - 2019 - 中期财报