香港交易及結算所有限公司及香港聯合交易所有限公司對本公佈的內容概不 負責，對其準確性或完整性亦不發表任何聲明，並明確表示，概不對因本公佈 全部或任何部份內容而產生或因倚賴該等內容而引致的任何損失承擔任何責 任。 Lee’s Pharmaceutical Holdings Limited 李 氏 大 藥 廠 控 股 有 限 公 司 * （於開曼群島註冊成立之有限公司） （股份代號：950） 截 至 二 零 二 三 年 六 月 三 十 日 止 六 個 月 中 期 業 績 公 佈 財務摘要 截至六月三十日止六個月 二零二三年 二零二二年 變動 千港元 千港元 收益 512,308 649,166 -21.1% 毛利 284,463 419,478 -32.2% 本公司擁有人應佔溢利 16,117 28,460 -43.4% 港仙 港仙 ...

香港交易及結算所有限公司及香港聯合交易所有限公司對本公佈的內容概不 負責，對其準確性或完整性亦不發表任何聲明，並明確表示概不就因本公佈全 部或任何部分內容而產生或因倚賴該等內容而引致的任何損失承擔任何責任。 Lee’s Pharmaceutical Holdings Limited 李 氏 大 藥 廠 控 股 有 限 公 司 * （於開曼群島註冊成立之有限公司） （股份代號：950） 有 關 截 至 二 零 二 二 年 十 二 月 三 十 一 日 止 年 度 年 報 之 補 充 公 佈 茲提述李氏大藥廠控股有限公司（「本公司」）截至二零二二年十二月三十一日 止年度之年報（「年報」）。除非文義另有所指，否則本公佈所用之專有詞彙與年 報所界定者具相同涵義。 除年報「購股權計劃」一節及綜合財務報表附註中之附註37所提供之資料外， 董事會謹此就購股權計劃下之購股權提供以下進一步資料。 年報載列，2,510,000份購股權已於報告年度內註銷或失效，具體而言全部均為 於報告年度內按照二零一二年購股權計劃之條款失效之購股權，並無購股權 於報告年度內註銷。 以上額外資料並不影響年報所載任何其他資料。除本公佈所披露者外，年報所 ...

香港交易及結算所有限公司及香港聯合交易所有限公司對本公佈的內容概不 負責，對其準確性或完整性亦不發表任何聲明，並明確表示，概不對因本公佈 全部或任何部份內容而產生或因倚賴該等內容而引致的任何損失承擔任何責 任。 Lee’s Pharmaceutical Holdings Limited 李 氏 大 藥 廠 控 股 有 限 公 司 * （於開曼群島註冊成立之有限公司） （股份代號：950） 停 止 發 表 季 度 財 務 業 績 李氏大藥廠控股有限公司（「本公司」）董事會（「董事會」）宣佈，本公司將停止主 動公佈及發表本公司及其附屬公司（統稱「本集團」）本財政年度及往後財政年 度首三個月及九個月期間之季度財務業績。 董事會認為，終止發表季度財務業績將可減省本公司之時間、精力、成本及行 政負擔，讓本集團管理層可更加專注於本集團主要業務之營運及發展。本公司 將繼續適時而積極地與其股東及投資者溝通，並就本集團財務狀況不時提供 足夠透明度。董事會相信，停止發表季度財務業績不會犧牲或損害本公司股東 及投資者之利益。 本公司將繼續按照香港聯合交易所有限公司證券上市規則之規定公佈及發表 其中期及年度財務業績。 承董事會命 李 ...

Company Overview - The company has over 25 years of experience in the pharmaceutical industry in China, focusing on research-driven and market-oriented biopharmaceutical development[12]. - The group markets over 25 proprietary, generic, and licensed-in pharmaceutical products across Mainland China, Hong Kong, Macau, and Taiwan[13]. - The company has more than 40 products in various development stages, stemming from both internal R&D and licensing agreements with companies from the US, Europe, and Japan[14]. - The company has established extensive partnerships with over 20 international companies to enhance its product offerings[13]. - The group focuses on key disease areas such as cardiovascular, women's health, pediatrics, rare diseases, oncology, dermatology, and obstetrics[14]. Manufacturing and Operations - The manufacturing plant in Hefei, Anhui Province, operates four GMP-compliant workshops for producing topical gel, lyophilised powder for injection, small volume parenteral solutions, and eye gel[15]. - The Guangzhou manufacturing site includes a complete range of solid dosage production lines for tablets and capsules[15]. - The Group's Hefei site has completed production capacity expansion for Yallaferon® and upgrades for new prefilled syringe injection products[72]. - The Group's manufacturing operations are overseen by Victor Tsui, ensuring high standards in production management and quality control[189]. Financial Performance - Revenue for 2022 was HK$1,233,148,000, a decrease of 2.6% from HK$1,266,157,000 in 2021[25]. - Gross profit declined by 4.4% to HK$770,755,000 from HK$806,284,000 in the previous year[25]. - Profit attributable to the owners of the company plummeted by 97.4% to HK$51,284,000 compared to HK$1,987,176,000 in 2021[25]. - Equity attributable to the owners of the company decreased by 21.9% to HK$1,925,052,000 from HK$2,464,578,000 in 2021[25]. - Basic earnings per share fell by 97.4% to 8.71 HK cents from 337.58 HK cents in 2021[25]. - Total dividend per share was reduced by 67.2% to 2.0 HK cents from 6.1 HK cents in the previous year[25]. - The dividend payout ratio increased significantly to 23.0% from 1.8% in 2021[25]. - The Group's net current assets were HK$1,530,000, a significant decline from HK$40,740,000 in 2021[40]. - The Group's investment portfolio decreased to approximately HK$554,751,000 from HK$1,043,464,000 in 2021[135]. - The effective tax rate increased significantly by 32.1 percentage points to 32.6% for the Reporting Year[129]. Research and Development - The company has a diverse product portfolio including proprietary and licensed-in products across various markets[21][22]. - New product developments and market expansions are ongoing, focusing on therapeutic areas such as oncology and infectious diseases[21][22]. - Research and development efforts resulted in 7 ANDA and IDL approvals from NMPA, which are expected to drive future sales growth[45]. - The NDA for Adasuve® and ANDA applications for Epinastine Hydrochloride tablet and Apremilast tablet are currently under review by the CDE[73]. - The Group obtained 7 ANDA and IDL approvals from the NMPA during the reporting year[81]. Market Strategy and Expansion - The mission is to become a successful biopharmaceutical group in Asia, providing innovative products to improve health and quality of life[16]. - The company aims to expand its market presence and product portfolio through strategic partnerships and R&D initiatives[14]. - The Group is actively pursuing strategies for market expansion and potential acquisitions to enhance its product offerings[21][22]. - The Group's rare disease drugs, including Treprostinil Injection and Teglutik®, have been included in the updated NRDL, expanding patient access to these treatments[162]. - The Group's Fondaparinux Sodium was selected in the seventh-round VBP program, broadening its patient reach[104]. Cost Management and Efficiency - The Group remains committed to improving financial position through cost-saving measures while maintaining quality[52]. - The Group plans to implement cost control measures and enhance efficiency in sales and R&D to improve profitability and sustainability[163]. - The Group's administrative expenses were HK$198,413,000, a decrease of 33.3% compared to the previous year, reflecting efficient operations and cost-saving measures[67]. Leadership and Management - The Group's Chief Financial Officer, Chow Yiu Ming, has over 25 years of experience in accounting, auditing, financial management, and corporate finance[184]. - Dr. Li Xiaoyi, the founder of the Group, was responsible for daily operations and R&D from 1994 until April 2021, now serving as a non-executive director and senior adviser[172]. - The independent non-executive director, Dr. Chan Yau Ching, has extensive experience in corporate development and financial management of high-growth companies[177]. - The Group's management team includes professionals with advanced degrees, such as PhDs in relevant fields, enhancing the company's expertise in pharmaceuticals[172][183]. - The Group has been expanding its board with experienced individuals from various sectors, including private equity and healthcare management[173][175]. Employee and Organizational Changes - The Group had 1,102 employees as of December 31, 2022, a decrease from 1,321 employees in the previous year[151]. - The Group adopts a conservative treasury policy to manage liquidity and credit risks effectively[147]. - The Group believes it has adequate financial resources to meet future operational and development needs[145]. Product Development and Approval - Three new commercialized products, Treprostinil Injection, Teglutik®, and Trittico®, were added to the updated NRDL in January 2023, expected to enhance demand and sales[51]. - The expiration of the licensing agreement for Carnitene® significantly impacted the Group's revenue during the Reporting Year[57]. - The Group successfully included three newly commercialized products in the latest medical insurance drug list, expected to enhance demand and sales[54].

香港交易及結算所有限公司及香港聯合交易所有限公司對本公佈的內容概不 負責，對其準確性或完整性亦不發表任何聲明，並明確表示，概不對因本公佈 全部或任何部份內容而產生或因倚賴該等內容而引致的任何損失承擔任何責 任。 Lee’s Pharmaceutical Holdings Limited 李 氏 大 藥 廠 控 股 有 限 公 司 * （於開曼群島註冊成立之有限公司） （股份代號：950） 截 至 二 零 二 二 年 十 二 月 三 十 一 日 止 年 度 全 年 業 績 公 佈 財務摘要 截至十二月三十一日止年度 二零二二年 二零二一年 變動 千港元 千港元 收益 1,233,148 1,266,157 -2.6% 毛利 770,755 806,284 -4.4% 本公司擁有人應佔溢利 51,284 1,987,176 -97.4% 港仙 港仙 ...

Revenue and Sales Performance - The Group's revenue for the first nine months of 2022 totaled HK$1,036,182,000, an increase of 8.8% compared to HK$952,387,000 in the same period of 2021[7] - Third-quarter 2022 revenue was HK$387,016,000, reflecting a 5.1% increase year-over-year and a sequential increase of 19.3% over the second quarter of 2022[7] - Sales of newly launched BredininTM grew by 293.5%, contributing significantly to the overall sales growth, alongside Treprostinil Injection and Yallaferon® which grew by 30.8% and 3.1%, respectively[7] - Sales of licensed-in products accounted for 61.7% of the Group's revenue in the first nine months of 2022, up from 58.5% in the same period of 2021[8] - Revenue for the three months ended September 30, 2022, was HK$387,016,000, a decrease of 0.6% compared to HK$368,335,000 for the same period in 2021[88] - Proprietary and generic products generated revenue of HK$144,946,000 for the three months ended September 30, 2022, down 0.6% from HK$145,766,000 in 2021[91] - Licensed-in products revenue increased to HK$242,070,000 for the three months ended September 30, 2022, up 8.8% from HK$222,569,000 in 2021[91] - More than 90% of the Group's revenue was derived from activities conducted in the People's Republic of China during the reporting periods[92] Profitability and Expenses - Gross profit for the first nine months of 2022 was HK$661,801,000, a 4.3% increase from HK$634,796,000 in the same period last year[12] - The gross profit margin for the first nine months of 2022 was 63.9%, down 2.8 percentage points from 66.7% in the prior year[12] - Net profit attributable to the owners of the Company in the first nine months of 2022 was HK$62,684,000, a decrease of 97.1% compared to the same period in 2021, primarily due to the absence of one-off gains and losses from previous years[18] - The overall profit attributable to the company's owners for the first nine months of 2022 was HKD 62,684,000, a decrease of 97.1% compared to the same period in 2021, primarily due to the absence of one-time gains and losses from previous years[20] - Profit for the period attributable to owners of the Company for the three months ended September 30, 2022, was HK$34,224,000, compared to HK$13,843,000 in 2021, reflecting a significant increase of 147.5%[59] - The company reported a gross profit margin of approximately 62.5% for the three months ended September 30, 2022, compared to 67.2% in the same period of 2021[59] - Total comprehensive expense for the period was HK$241,210,000 for the three months ended September 30, 2022, compared to HK$581,889,000 in 2021, indicating a reduction of 58.6%[63] Research and Development - Research and development expenses totaled HK$293,795,000 in the first nine months of 2022, a decrease of 14.9% compared to HK$345,218,000 in the same period of 2021, representing 28.4% of revenue[13] - Research and development expenses for the three months ended September 30, 2022, were HK$50,263,000, down from HK$67,549,000 in 2021, a decrease of 25.6%[59] - The group has over 40 projects in its pipeline, ranging from early to late-stage development[26] - The group is developing several assets in major therapeutic areas, including cardiovascular and oncology, with late-stage programs such as Cetraxal® Plus and Intrarosa®[29][31] - The group has completed three pivotal registration batches of oral cytotoxic drugs in its specialized workshop[25] Regulatory Approvals and Product Launches - The group obtained 7 ANDA and Import Drug License approvals from China's National Medical Products Administration during the review period[34] - Zingo® received its Drug Registration Certificate from the NMPA on March 1, 2022, and is indicated for local analgesia prior to venipuncture in children and adults[35] - INOmax® was approved by the NMPA on March 8, 2022, for the treatment of hypoxic respiratory failure associated with pulmonary hypertension in infants[37] - High-concentration Carboprost injection received drug registration approval on March 9, 2022, with a specification of 50 mg in a 20 ml vial[40] - Natulan® (Procarbazine Hydrochloride Capsules) obtained drug registration approval on April 21, 2022, for treating Hodgkin's lymphoma in adults[42] - Teglutik® (Riluzole Oral Suspension) received drug registration approval on May 31, 2022, to prolong life in ALS patients[42] Corporate Strategy and Future Outlook - The Group launched its flagship online stores on Alibaba.com and JD.com in March 2022 to enhance brand awareness and expand sales channels[17] - The Group plans to sell 100% equity interest in Guangzhou Zhaokang Hospital for RMB 200 million (approximately HK$ 226 million) as part of its corporate development strategy[47] - The Group anticipates continued pressure on drug prices due to external factors such as the COVID pandemic and rising inflation, impacting the pharmaceutical industry[51] - The expiration of the licensing agreement for Carnitene® marks a new era for the Group, which will focus on developing domestic generic versions to maintain competitiveness[52] - The Group has implemented measures to enhance efficiency across the value chain, particularly in sales and R&D, to adapt to the "new normal"[55] - The Group aims to adopt prudent business strategies to strengthen its foundation and drive growth, ultimately creating more value for shareholders and customers[56] Financial Position and Dividends - The total assets reported as of September 30, 2022, were 3,710,088[72] - Capital commitments as of 30 September 2022 amounted to HK$227,368,000, a decrease from HK$249,848,000 as of 31 December 2021[122] - The Company reported no purchases, sales, or redemptions of its listed securities during the nine months ended 30 September 2022[124] - Total compensation for key management personnel during the reporting period was HK$24,748,000, a decrease from HK$65,647,000 in the previous year[116] - An interim dividend of HK$0.010 per share was declared for the six months ended 30 June 2022, totaling approximately HK$5,888,000, down from HK$0.030 per share totaling HK$17,665,000 in the previous year[103] - The Company does not recommend the payment of any interim dividend for the nine months ended 30 September 2022, compared to no dividend in the same period of 2021[125]

Revenue and Sales Performance - The Group's revenue for the first half of 2022 totaled HK$649,166,000, representing an increase of 11.1% compared to HK$584,052,000 in the same period of 2021[7]. - The second-quarter 2022 revenue was HK$324,416,000, up 7.8% from HK$300,910,000 in the prior-year quarter[7]. - Sales of newly launched Bredinin™ increased by 48.9%, while Treprostinil Injection and Yallaferon® grew by 4.7% in the first half of 2022[7]. - The sales of licensed-in products accounted for 61.2% of the Group's revenue in the first half of 2022, up from 57.3% in the same period of 2021[8]. Profitability and Expenses - Gross profit for the first half of 2022 was HK$419,478,000, an increase of 8.5% from HK$386,546,000 in the same period last year[11]. - The overall gross profit margin decreased to 64.6% from 66.2% in the first half of 2021 due to a higher proportion of revenue from licensed-in products[11]. - Research and development expenses totaled HK$206,517,000, a decrease of 14.0% compared to HK$240,043,000 in the first half of 2021, representing 31.8% of the corresponding revenue[12]. - Selling and distribution expenses increased by 7.4% to HK$176,215,000 in the first half of 2022, with a selling expenses to revenue ratio of 27.1%[16]. - Net profit attributable to the owners of the Company was HK$28,460,000, a decrease of 98.7% compared to the same period in 2021, primarily due to the absence of one-off gains and losses from previous years[17]. - Other losses (net) for the first half of 2022 amounted to HK$5,227,000, a significant turnaround from other gains (net) of HK$2,093,266,000 in the first half of 2021, primarily due to the absence of a one-off gain of approximately HK$2.32 billion[56]. Research and Development - The Group has over 40 projects in its pipeline, with applications for New Drug Applications (NDA) and Abbreviated New Drug Applications (ANDA) under review by the Centre for Drug Evaluation (CDE)[23]. - Major therapeutic areas under development include cardiovascular, women's health, pediatrics, rare diseases, dermatology, and obstetrics, with late-stage programs such as Cetraxal® Plus and Intrarosa® progressing well[26]. - The oncology pipeline includes 10 assets, with several in advanced clinical trial stages, including Socazolimab for recurrent cervical cancer and small cell lung cancer[27]. - Research and development expenses for the first half of 2022 amounted to HK$116,590,000, an increase of 3.3% compared to HK$112,899,000 in the same period last year, representing 18.0% of the Group's revenue, down from 19.3%[62]. Product Development and Approvals - The Group obtained 6 ANDA and IDL approvals from the National Medical Products Administration (NMPA) during the review period[31]. - Zingo® received its Drug Registration Certificate from the NMPA on March 1, 2022, providing local analgesia for children and adults[32]. - INOmax® was approved by the NMPA on March 8, 2022, for treating hypoxic respiratory failure in infants[34]. - High Concentration Treprostinil Injection received its Drug Registration Certificate from the NMPA on March 9, 2022[37]. - The Group has obtained Drug Registration Certificates for Natulan® and Teglutik®, expanding its product offerings in the oncology and neurology sectors[40][42]. Strategic Initiatives and Future Outlook - The Group launched its flagship online stores on Alibaba.com and JD.com in March 2022 to enhance brand awareness and expand sales channels[16]. - The Group anticipates that more products will enter the volume-based procurement (VBP) program in China, which is expected to provide additional revenue streams[51]. - The Group has six newly approved products during the review period and expects two more NDA approvals by the end of 2022, which will contribute to new revenue sources[51]. - The company plans to expand its market presence with new product launches and technology developments in the upcoming fiscal periods[92]. - The company is focusing on strategic acquisitions to enhance its market position and drive future growth[92]. - The company is committed to improving operational efficiency and reducing costs to enhance profitability in the coming years[92]. Financial Position and Employee Information - As of June 30, 2022, the total balance of other payables and accruals was HK$676,710,000, down from HK$724,670,000 as of December 31, 2021, primarily due to the settlement of accruals[68]. - The group's current ratio as of June 30, 2022, was 1.04, unchanged from December 31, 2021, indicating stable liquidity[69]. - The net cash position as of June 30, 2022, was HK$147,543,000, significantly up from HK$30,899,000 as of December 31, 2021[70]. - Total employee remuneration for the period under review was approximately HK$200.9 million, compared to HK$180.3 million for the six months ended June 30, 2021[79]. - The group had 1,182 employees as of June 30, 2022, a decrease from 1,319 employees as of December 31, 2021[78]. - The group has no pledge of assets as of June 30, 2022, indicating a strong asset position[77]. - The group believes it has adequate financial resources to meet its operational and development requirements in the future[73].

Financial Performance - The Group's revenue for Q1 2022 was HK$324,750,000, representing a 14.7% increase compared to HK$283,142,000 in Q1 2021[4]. - The gross profit for Q1 2022 was HK$215,826,000, with a gross profit margin of 66.5%, a decrease of 1.5 percentage points from 68.0% in Q1 2021[4]. - Net profit attributable to the owners of the Company in Q1 2022 was HK$20,307,000, a decrease of 50.5% compared to the same quarter in 2021[11]. - For the three months ended March 31, 2022, the revenue was HK$324,750,000, an increase from HK$283,142,000 in the same period of 2021, representing a growth of approximately 14.7%[42]. - Profit for the period decreased to HK$20,665,000 from HK$36,356,000 year-over-year, reflecting a decline of approximately 43.3%[44]. - Basic earnings per share for Q1 2022 was HK$3.45, down from HK$6.98 in Q1 2021, a decrease of about 50.6%[42]. - The total comprehensive expense for the period was HK$304,203,000, compared to HK$61,956,000 in the previous year, indicating a significant increase in expenses[44]. - The operating profit for the period was HK$35,503,000, down from HK$47,366,000 in the previous year, reflecting a decline of approximately 25.1%[42]. - The total comprehensive expense for the period was HK$53,047, highlighting the financial challenges faced during this timeframe[51]. - The total interest income for the Group was HK$24,621,000, down from HK$31,581,000 in the same period of 2021[80]. - The Group's taxation for the three months ended 31 March 2022 amounted to HK$12,846,000, compared to HK$7,475,000 in the same period of 2021[84]. Revenue Composition - Sales from licensed-in products accounted for 61.8% of total revenue in Q1 2022, up from 55.6% in Q1 2021, while proprietary and generic products contributed 38.2%, down from 44.4%[4]. - Revenue from proprietary and generic products was HK$124,020,000, while revenue from licensed-in products was HK$200,730,000, indicating a significant contribution from licensed-in products[74]. - More than 90% of the Group's revenue was derived from activities conducted in the People's Republic of China (PRC) during the reporting period[76]. Research and Development - R&D expenses totaled HK$103,801,000 in Q1 2022, representing 32.0% of quarterly revenue, compared to 27.0% in Q1 2021[6]. - The Group aims to optimize resource allocation among prioritized R&D projects while keeping expenditures within revenue limits for the fiscal year ending December 2022[6]. - The Group has over 40 projects in its pipeline, ranging from early to late-stage development, with several applications under review by the Centre for Drug Evaluation (CDE) and the National Medical Products Administration (NMPA) for various drugs[15][17][21][24]. - The oncology pipeline includes 10 assets, with 6 innovative and 4 generics, focusing on immuno-oncology, including Socazolimab in various clinical trial stages for cervical cancer and small cell lung cancer[20][23]. Product Approvals and Developments - The Group obtained 4 ANDA and IDL approvals from NMPA during the quarter[21][24]. - Zingo® received its Drug Registration Certificate on March 1, 2022, for use in local analgesia prior to venipuncture in children and adults[22][25]. - INOmax® was approved on March 8, 2022, for treating hypoxic respiratory failure associated with pulmonary hypertension in infants[27][30]. - High Concentration Treprostinil Injection received approval on March 9, 2022, with a specification of 20ml: 50mg[28][31]. - Natulan® was approved on April 21, 2022, for use in combination with chemotherapy to treat Hodgkin's lymphoma in adults[29][32]. - The Group anticipates more NDA approvals in 2022, including Teglutik® for Amyotrophic Lateral Sclerosis (ALS) and Nadroparin Calcium Injection[34][36]. Strategic Initiatives - The Group launched flagship online stores on Alibaba.com and JD.com in March 2022 to enhance brand awareness and expand sales channels[7]. - The Group is focusing on efficiency across the value chain, particularly in sales and R&D, to adapt to the new normal[35]. - The company is focusing on optimizing its product portfolio to create development opportunities amid a challenging regulatory environment[38]. - The company has implemented measures to adapt to the "new normal," emphasizing efficiency in key processes such as sales and R&D[38]. Financial Position and Investments - The total retained profits stood at HK$2,100,295, indicating a strong accumulation of earnings over time[51]. - The total share capital was reported at HK$5,000, indicating a stable equity base[51]. - The company has a significant investment in financial assets, with fair value changes impacting overall financial performance[51]. - Capital commitments for intangible assets (license fee and development cost) amounted to HK$36,730,000, while property, plant, and equipment commitments were HK$143,945,000, totaling HK$266,949,000[114]. Corporate Governance and Compliance - The company has applied new amendments to HKFRS for the first time, which are effective for annual periods beginning on or after January 1, 2022, without material impact on reported amounts[63]. - The unaudited condensed consolidated financial statements were prepared in accordance with Hong Kong Accounting Standards, ensuring compliance with local regulations[54]. - The company has not early adopted new HKFRS amendments that are issued but not yet effective, indicating a cautious approach to accounting changes[68]. - The Board does not recommend payment of dividends for the three months ended 31 March 2022, consistent with the previous year[115].

Product Portfolio and Development - Lee's Pharmaceutical currently markets over 25 proprietary, generic, and licensed-in pharmaceutical products across Mainland China, Hong Kong, Macau, and Taiwan[8] - The Group has more than 40 products in various stages of development, focusing on key disease areas such as cardiovascular, women's health, pediatrics, rare diseases, oncology, dermatology, and obstetrics[8] - The company has a diverse product portfolio including proprietary and licensed-in products for various medical applications[10] - The Group's product portfolio has expanded from standard drugs to specialty drugs, with recent launches including Treprostinil Injection and Sodium Phenylbutyrate Granules, aiming for further growth opportunities[118] - Five products received ANDA and IDL approvals from the National Medical Products Administration during the Reporting Year, enhancing the Company's product range[35] - The Group is expecting IDL approvals for Riluzole Oral Suspension and Procarbazine Hydrochloride Capsule soon, further expanding its product offerings[35] - Sodium Phenylbutyrate Granules, the first generic version in China, received drug registration certification from NMPA, addressing unmet medical needs in the country[70] - Zingo® (Lidocaine Hydrochloride Powder Intradermal Injection System) received drug registration certification from NMPA, providing local analgesia in children and adults[73] - INOmax® (nitric oxide gas for inhalation) obtained drug registration certification from NMPA for treating hypoxic respiratory failure associated with pulmonary hypertension in infants[73] - High Concentration Treprostinil Injection (20ml:50mg) developed by Zhaoke Pharmaceutical (Hefei) received drug registration certification from NMPA[77] Financial Performance - For the year ended December 31, 2021, revenue increased by 4.1% to HK$1,266,157,000 compared to HK$1,216,716,000 in 2020[15] - Gross profit rose by 3.2% to HK$806,284,000 from HK$781,066,000 in the previous year[15] - Profit attributable to the owners of the Company surged by 1,436.7% to HK$1,987,176,000, up from HK$129,316,000 in 2020[15] - Equity attributable to the owners of the Company increased by 14.6% to HK$2,464,578,000 from HK$2,149,795,000 in 2020[15] - Basic earnings per share jumped by 1,435.2% to HK$337.58, compared to HK$21.99 in the prior year[15] - Total dividend per share increased by 5.2% to HK$6.1 from HK$5.8 in 2020[15] - The dividend payout ratio decreased significantly to 1.8% from 26.4% in the previous year[15] - The Group recorded a net profit attributable to owners of HK$1,987,176,000, an increase of approximately 14.4 times compared to the previous year, aided by a one-time gain of approximately HK$2.3 billion from the derecognition of investment in Zhaoke Ophthalmology Limited[58] - The Group's revenue increased by HK$49,441,000 or 4.1%, from HK$1,216,716,000 in 2020 to HK$1,266,157,000 in 2021[84] - Sales of licensed-in products amounted to HK$749,135,000, accounting for 59.2% of the Group's revenue, while proprietary and generic products contributed HK$517,022,000, or 40.8%[44] Research and Development - The Group focuses on both internal research and development as well as licensing development, commercialization, and manufacturing rights from various international companies[8] - R&D expenses totaled HK$463,147,000, representing 36.6% of the corresponding yearly revenue, with HK$243,835,000 recognized as expenses and HK$219,312,000 capitalized as intangible assets[52] - Research and development expenses increased to HK$463,147,000, representing 36.6% of the corresponding year's revenue, up from 32.0% in the previous year[55] - The Group has over 40 projects in its pipeline, with several applications for drug licenses under review by the Centre for Drug Evaluation[64] - The Group will continue to monitor its investment portfolio and explore monetization opportunities as appropriate[99] Strategic Partnerships and Market Expansion - The Group has established extensive partnerships with over 20 international companies to enhance its product offerings and market reach[8] - The company is focused on expanding its market presence in China, Hong Kong, Macau, and Taiwan[10] - New product development and strategic partnerships are key components of the company's growth strategy[10] - The Group will implement a sales business unit responsibility scheme and expand its product portfolio towards specialty drugs to create growth opportunities[39] Management and Governance - The Group has a strong management team with diverse expertise in finance, marketing, and life sciences[141] - The Group's Chief Financial Officer, Chow Yiu Ming, has over 25 years of experience in accounting and corporate finance, indicating strong leadership in financial management[144] - The Group established a Risk Control Centre in 2020, enhancing its strategic planning and compliance capabilities[146] - The Group's commitment to compliance and audit functions is reinforced by the establishment of the Risk Control Centre, which is crucial for maintaining operational integrity[146] - The Group's financial governance is strong, supporting its strategy to return to a growth trajectory and create long-term shareholder value[120] Operational Challenges and Future Outlook - The Volume-Based Procurement program has continued to roll out across the country, leading to reduced prices for public hospitals[32] - The Group anticipates that the Value-Based Pricing (VBP) program in China will continue, potentially covering over 300 drugs by the end of 2022, which may impact sales dynamics[113] - The Group expects to benefit from new laws and regulations in the long run, while implementing measures to navigate current challenges[113] - The Group's management will continue to monitor foreign currency exposure and consider hedging when necessary to mitigate risks[111] Employee and Community Engagement - The Group employed 1,319 individuals as of December 31, 2021, an increase from 1,302 employees in the previous year[113] - Charitable donations made by the Group during the year amounted to HK$7,462,000, an increase from HK$2,588,000 in 2020[185]

Financial Performance - For the first nine months of 2021, the Group's revenue totaled HK$952,387,000, representing a 6.5% increase compared to HK$894,042,000 in the same period of 2020[6]. - The Group's third-quarter 2021 revenue was HK$368,335,000, a 9.2% increase year-over-year and a 22.4% sequential increase from the second quarter of 2021[6]. - Gross profit for the first nine months of 2021 was HK$634,796,000, up 10.3% from HK$575,669,000 in the same period last year[10]. - The Group achieved a net profit attributable to owners of HK$2,169,043,000, an increase of approximately 16.8 times over the first nine months of 2020, aided by a one-time gain of HK$2.3 billion from the derecognition of investment in Zhaoke Ophthalmology Limited[19][21]. - For the three months ended September 30, 2021, the Group reported revenue of HK$368,335,000, a 9.3% increase from HK$337,326,000 in the same period of 2020[88]. - Gross profit for the same period was HK$248,250,000, representing a 17.9% increase compared to HK$210,050,000 in 2020[88]. - The Group's profit for the period was HK$11,084,000 for the three months ended September 30, 2021, compared to HK$3,749,000 in 2020[88]. - The total comprehensive income for the nine months ended 30 September 2021 was HK$782,264,000, compared to a loss of HK$127,934,000 in 2020[91]. Research and Development - Research and development expenses for the first nine months of 2021 amounted to HK$345,218,000, representing 36.2% of the corresponding revenue, compared to 30.0% in the same period of 2020[17]. - The Group's R&D efforts focus on major therapeutic areas including cardiovascular, women's health, pediatrics, rare diseases, dermatology, and oncology[12]. - The Group has over 40 projects in various stages of drug development[25][28]. - The NDA for Lutrate® Depot for advanced prostate cancer treatment has been accepted for review by the NMPA[37]. - The Group successfully launched Cetraxal® Plus in the Hong Kong market on October 4, 2021, after completing the required enrollment of 600 subjects in a Phase III clinical trial[31][34]. - The clinical trial for Intrarosa® has been approved, with the first patient enrolled on September 13, 2021, targeting vulvovaginal atrophy[32][35]. - The Group's oncology R&D arm, China Oncology Focus Limited (COF), is developing 10 oncology assets, including 5 innovative and 5 generics, targeting various cancers[58][59]. Product Sales and Market Performance - Sales of licensed-in products accounted for 58.5% of the Group's revenue in the first nine months of 2021, while proprietary and generic products contributed 41.5%[7]. - The sales growth of key products included Yallaferon® (70.7%), Ferplex® (33.7%), and Treprostinil Injection (125.0%) during the first nine months of 2021[6]. - For the three months ended September 30, 2021, the Group's revenue from proprietary and generic products was HK$145,766,000, a decrease of 4.9% from HK$152,533,000 in 2020[124]. - Revenue from licensed-in products for the same period was HK$222,569,000, an increase of 20.4% compared to HK$184,793,000 in 2020[124]. - More than 90% of the Group's revenue was derived from activities conducted in the People's Republic of China[125]. Financial Position and Capital Management - The retained profits as of 30 September 2021 were HK$3,710,088,000, an increase from HK$2,149,795,000 at the beginning of the year[94]. - The share capital as of 30 September 2021 was HK$29,442,000, slightly decreased from HK$29,406,000 at the beginning of the year[94]. - The company reported a fair value change of financial assets at fair value through other comprehensive income of HK$1,384,331,000 for the nine months ended 30 September 2021[91]. - The exchange reserve as of 30 September 2021 was a deficit of HK$1,633,719,000, compared to a deficit of HK$254,155,000 at the beginning of the year[94]. - As of September 30, 2021, the company had capital commitments of HK$242,093,000, which includes HK$40,931,000 for intangible assets and HK$114,123,000 for property, plant, and equipment[160]. Taxation and Dividends - For the three months ended September 30, 2021, Hong Kong Profits Tax was (HK$7,120,000), compared to HK$8,019,000 for the same period in 2020, representing a decrease of approximately 88.8%[133]. - For the nine months ended September 30, 2021, the total Hong Kong Profits Tax was (HK$10,075,000), down from HK$30,845,000 in 2020, indicating a decline of approximately 67.4%[133]. - An interim dividend of HK$0.030 per share was declared for the six months ended 30 June 2021, totaling approximately HK$17,665,000, an increase from HK$15,879,000 in the same period of 2020[137]. - The company does not recommend the payment of any other interim dividend for the nine months ended September 30, 2021, compared to no dividends in the same period of 2020[137]. Corporate Governance and Compliance - The unaudited condensed consolidated financial statements for the nine months ended September 30, 2021, have been prepared in accordance with Hong Kong Accounting Standards and applicable disclosure requirements[102]. - The financial statements do not include all information required in the annual financial statements and should be read in conjunction with the Group's annual financial statements for the year ended December 31, 2020[104]. - The accounting policies and methods used for the preparation of the financial statements are consistent with those used in the Group's annual financial statements for the year ended December 31, 2020[105]. - The Group has applied amendments to HKASs and HKFRSs for the first time in the current reporting period, which had no material effect on the reported amounts[114].