FF305 翌日披露報表 (股份發行人 ── 已發行股份或庫存股份變動、股份購回及/或在場内出售庫存股份) 表格類別： 股票 狀態： 新提交 公司名稱： 康寧傑瑞生物製藥 呈交日期： 2024年10月29日 如上市發行人的已發行股份或庫存股份出現變動而須根據《香港聯合交易所有限公司（「香港聯交所」）證券上市規則》(「《主板上市規則》」)第13.25A條 / 《香港聯合交易所有限公司GEM證券 上市規則》(「《GEM上市規則》」)第17.27A條作出披露，必須填妥第一章節 。 | 第一章節 | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 | 是 | | | 證券代號 (如上市) | 09966 | 說明 | 普通股 | | | | | | A. 已發行股份或庫存股份變動 | | | | | | | | | | | 已發行股份（不包括庫存股份）變動 | | | 庫存股份變動 | | | | | 事件 | 已發行股份（不包括庫存股份）數 目 | | ...

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告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不對因本公告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。 ALPHAMAB ONCOLOGY 康寧傑瑞生物製藥 豁免嚴格遵守《上市規則》第3.28條及第8.17條 茲提述康寧傑瑞生物製藥（「本公司」）日期為2024年10月22日的公告（「該公 告」），內容有關（其中包括）更換本公司聯席公司秘書。 根據《香港聯合交易所有限公司（「聯交所」）證券上市規則》（「《上市規則》」）第 8.17條，上市發行人須委任一名符合《上市規則》第3.28條規定的公司秘書。《上市 規則》第3.28條規定，上市發行人須委任一名人士為其公司秘書，該名人士必須為 聯交所認為在學術或專業資格或有關經驗方面足以履行上市發行人公司秘書職能 的人士。 如該公告所述，程湫漤女士（「程女士」）目前尚不具備《上市規則》所規定的相關 學術或專業資格或相關經驗。本公司已向聯交所申請豁免嚴格遵守《上市規則》第 3.28條及第8.17條規定（「豁免」）。 本公司董事（「董事」）會（「董事會」）謹此宣佈，聯交所已 ...

FF305 翌日披露報表 (股份發行人 ── 已發行股份或庫存股份變動、股份購回及/或在場内出售庫存股份) 表格類別： 股票 狀態： 新提交 公司名稱： 康寧傑瑞生物製藥 呈交日期： 2024年10月23日 如上市發行人的已發行股份或庫存股份出現變動而須根據《香港聯合交易所有限公司（「香港聯交所」）證券上市規則》(「《主板上市規則》」)第13.25A條 / 《香港聯合交易所有限公司GEM證券 上市規則》(「《GEM上市規則》」)第17.27A條作出披露，必須填妥第一章節 。 | 第一章節 | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 | 是 | | | 證券代號 (如上市) | 09966 | 說明 | 普通股 | | | | | | A. 已發行股份或庫存股份變動 | | | | | | | | | | | 已發行股份（不包括庫存股份）變動 | | | 庫存股份變動 | | | | 事件 | | 已發行股份（不包括庫存股份）數 目 | | ...

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告之內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不就因本公告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。 ALPHAMAB ONCOLOGY 康寧傑瑞生物製藥 （於開曼群島註冊成立的有限公司） （股份代號：9966） (1)根據首次公開發售後購股權計劃授出購股權；及 (2)根據限制性股份獎勵計劃授出獎勵股份 本公告乃根據《香港聯合交易所有限公司（「聯交所」）證券上市規則》（「上市規 則」）第17.06A、17.06B及17.06C條而作出。 茲提述康寧傑瑞生物製藥（「本公司」，連同其附屬公司，統稱「本集團」）日期為 2020年4月14日及2021年3月23日的公告、2024年5月21日的通函及2024年6月12 日舉行之股東週年大會投票表決結果公告（「該等公告及通函」），內容有關（其中 包括）採納首次公開發售後購股權計劃（「首次公開發售後購股權計劃」）及採納限 制性股份獎勵計劃（「限制性股份獎勵計劃」）、修訂其各自的計劃規則及更新計劃 授權限額。除另有界定者外，本公告所用詞彙與該等公告及通函所界定者具有相 ...

[Company Overview](index=11&type=section&id=Company%20Overview) [Company Profile](index=11&type=section&id=Company%20Profile) Alphamab Oncology is a biopharmaceutical company focused on oncology treatments, leveraging its bispecific antibody, multifunctional protein, and ADC technology platforms - The company positions itself as a leading biopharmaceutical company in China, specializing in innovative therapeutic biologics in bispecific antibodies, multifunctional protein engineering, and ADC fields[16](index=16&type=chunk) - The product pipeline is highly differentiated, including the marketed KN035 (Envida®) and three late-stage clinical products such as KN046 (PD-L1/CTLA-4 BsAb) and KN026 (HER2 BsAb)[17](index=17&type=chunk)[18](index=18&type=chunk) - Next-generation ADC drugs like JSKN003 (HER2 ADC), JSKN033 (ADC combination), and JSKN016 (HER3/TROP2 ADC) are actively progressing in clinical trials, with positive early data presented at multiple international academic conferences[19](index=19&type=chunk) [Company Information](index=14&type=section&id=Company%20Information) This section lists key company information including the core management team, committee members, company secretary, registered office, principal place of business, legal advisors, auditors, and share registrar - The Chairman and CEO is founder Dr. Ting Xu. The composition of the Audit, Remuneration, Nomination, and Strategy Committees is clearly defined[20](index=20&type=chunk) - The company's auditor is Deloitte Touche Tohmatsu[22](index=22&type=chunk) [Business and Financial Highlights](index=16&type=section&id=Business%20and%20Financial%20Highlights) [Financial Highlights](index=16&type=section&id=Financial%20Highlights) In the first half of 2024, the company's revenue increased by **27.2%** year-on-year to **RMB 174 million**, with gross profit growing **38.2%** to **RMB 143 million**. Loss for the period expanded slightly to **RMB 44.9 million** from **RMB 39.9 million** in the prior year period. Net assets remained stable Key Financial Data for H1 2024 (Condensed Consolidated Statement of Profit or Loss) | Indicator | 2024 H1 (RMB Thousands) | 2023 H1 (RMB Thousands) | | :--- | :--- | :--- | | Revenue | 173,561 | 136,465 | | Gross Profit | 142,754 | 103,300 | | R&D Expenses | (194,531) | (194,681) | | Loss for the Period | (44,896) | (39,862) | | Total Comprehensive Expenses | (44,614) | (40,434) | Balance Sheet Summary as of June 30, 2024 | Indicator | June 30, 2024 (RMB Thousands) | December 31, 2023 (RMB Thousands) | | :--- | :--- | :--- | | Non-current Assets | 549,170 | 578,583 | | Current Assets | 1,592,832 | 1,558,530 | | Net Assets | 1,628,751 | 1,672,112 | [Business Highlights](index=17&type=section&id=Business%20Highlights) During the reporting period, the company achieved significant progress in its product pipeline, external collaborations, and production capacity. The Phase III clinical trial for core product KN046 completed final OS analysis, showing positive results. Multiple ADC drugs (JSKN003, JSKN016, JSKN033) advanced smoothly in clinical trials, and an ADC development collaboration was established with ArriVent. KN035 was approved for launch in Macau and production capacity expanded - The Phase III clinical trial of KN046 for advanced squamous non-small cell lung cancer (sq NSCLC) completed final OS analysis, demonstrating statistically significant OS benefit after model adjustment, with significant PFS benefit also observed[17](index=17&type=chunk)[27](index=27&type=chunk) - ADC pipeline progressed rapidly: JSKN003 presented positive Phase I data at AACR and ASCO annual meetings; JSKN016 completed first patient dosing in China; JSKN033 completed first patient dosing in Australia[26](index=26&type=chunk)[27](index=27&type=chunk) - External collaborations achieved breakthroughs, including a licensing agreement with Glenmark for the development and commercialization of KN035 in multiple overseas markets, and a research collaboration with ArriVent BioPharma, Inc. for the discovery and development of novel ADC products[26](index=26&type=chunk)[27](index=27&type=chunk) - Production base capacity continued to expand, with **6,000L** capacity expansion completed and operational, and construction of ADC drug substance and drug product manufacturing facilities initiated[28](index=28&type=chunk) [Management Discussion and Analysis](index=19&type=section&id=Management%20Discussion%20and%20Analysis) [Product Pipeline, Commercialization, and Future Development](index=19&type=section&id=Product%20Pipeline%2C%20Commercialization%2C%20and%20Future%20Development) Leveraging its proprietary technology platforms, the company has built a differentiated oncology drug pipeline including monoclonal antibodies, bispecific antibodies, and ADCs. KN035 has been successfully commercialized, with core products KN046 and KN026 planned for NDA submission in 2025. Future strategies include enriching early-stage pipelines, focusing on bispecific antibodies and bispecific ADCs, and actively pursuing global strategic collaborations - The company possesses multiple proprietary technology platforms, including sdAb/monoclonal antibody, CRIB, CRAM, and BADC, supporting its diverse drug candidate development[32](index=32&type=chunk) - Regarding commercialization, KN035 (Envida®) commenced commercialization in November 2021. Core products KN046 and KN026 are expected to submit NDAs in 2025[33](index=33&type=chunk) - Future development strategy focuses on leveraging in-house R&D capabilities to enrich early-stage pipelines, particularly in tumor immunotherapy bispecific antibodies and bispecific ADCs, and will continue to seek strategic collaboration opportunities such as co-development and out-licensing for core products[34](index=34&type=chunk) [Financial Review](index=21&type=section&id=Financial%20Review) Total revenue for the first half of 2024 increased by **27.2%** year-on-year, primarily driven by a significant increase in license fee income. R&D expenses remained stable, while other income substantially decreased due to exchange rate impacts. Loss for the period expanded from **RMB 39.9 million** to **RMB 44.9 million** [Revenue Analysis](index=21&type=section&id=Revenue%20Analysis) Total revenue for the first half of 2024 was **RMB 173.6 million**, a **27.2%** year-on-year increase. This growth was primarily driven by license fee income, which significantly rose from **RMB 7.2 million** in the prior year period to **RMB 78.2 million**, while drug sales and royalty income decreased Revenue Composition (For the Six Months Ended June 30) | Revenue Source | 2024 (RMB Thousands) | 2023 (RMB Thousands) | | :--- | :--- | :--- | | Drug Sales and Royalty Income | 90,643 | 117,015 | | License Fee Income | 78,613 | 7,511 | | Provision of R&D Project Goods/Consumables | 4,305 | 11,939 | | **Total** | **173,561** | **136,465** | - The significant increase in license fee income (recognized at a point in time) primarily stemmed from new collaboration and licensing agreements signed in the first half of 2024[38](index=38&type=chunk) - Drug sales and royalty income decreased year-on-year, with sales-based royalty income declining from **RMB 45.5 million** to **RMB 20.8 million**[38](index=38&type=chunk) [Cost and Expense Analysis](index=23&type=section&id=Cost%20and%20Expense%20Analysis) During the reporting period, cost of sales and administrative expenses remained relatively stable. R&D expenses were **RMB 194.5 million**, largely consistent with the prior year period, with staff costs and outsourced service fees being the main components, accounting for **34.3%** and **27.8%** respectively - Cost of sales slightly decreased from **RMB 33.2 million** to **RMB 30.8 million**, remaining relatively stable[39](index=39&type=chunk) R&D Expense Composition (For the Six Months Ended June 30) | Expense Nature | 2024 (RMB Thousands) | Proportion | 2023 (RMB Thousands) | Proportion | | :--- | :--- | :--- | :--- | :--- | | Outsourced Service Fees | 54,040 | 27.8% | 64,156 | 33.0% | | Staff Costs | 66,861 | 34.3% | 66,961 | 34.4% | | Raw Material Costs | 28,326 | 14.6% | 23,924 | 12.3% | | Depreciation and Amortization, etc. | 36,566 | 18.8% | 30,905 | 15.9% | | Others | 8,738 | 4.5% | 8,735 | 4.4% | | **Total** | **194,531** | **100.0%** | **194,681** | **100.0%** | [Balance Sheet and Cash Flow Analysis](index=25&type=section&id=Balance%20Sheet%20and%20Cash%20Flow%20Analysis) As of June 30, 2024, the company's net assets were **RMB 1.629 billion**. Cash and cash equivalents increased to **RMB 1.14 billion**. Current ratio and quick ratio decreased but remained at healthy levels. Total bank borrowings increased to **RMB 320 million** - Inventories decreased from **RMB 78.7 million** to **RMB 65.2 million**, primarily due to optimized inventory management[51](index=51&type=chunk) - As of June 30, 2024, cash and cash equivalents were **RMB 1.14 billion**, an increase from **RMB 1.086 billion** at the end of 2023[54](index=54&type=chunk) - Bank borrowings increased from **RMB 250 million** to **RMB 320 million** to support working capital needs[60](index=60&type=chunk) Key Financial Ratios | Ratio | June 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Current Ratio | 4.61 | 5.84 | | Quick Ratio | 4.42 | 5.55 | | Debt-to-Equity Ratio | (0.50) | (0.50) | [Corporate Governance and Other Information](index=30&type=section&id=Corporate%20Governance%20and%20Other%20Information) [Share Incentive Schemes](index=35&type=section&id=Share%20Incentive%20Schemes) The company has Pre-IPO and Post-IPO Share Option Schemes and a Restricted Share Award Scheme to incentivize employees. During the reporting period, **1.18 million** share options were granted under the Post-IPO Share Option Scheme, and **130,000** award shares were granted under the Restricted Share Award Scheme. The company revised relevant scheme terms and updated authorization limits in June 2024 - During the reporting period, **406,065** share options under the Pre-IPO Share Option Scheme were cancelled, and **80,000** were exercised[85](index=85&type=chunk) - During the reporting period, **1,180,000** new share options were granted under the Post-IPO Share Option Scheme, with an exercise price of **HKD 4.350**; an additional **120,000** share options lapsed[86](index=86&type=chunk)[87](index=87&type=chunk) - During the reporting period, **130,000** award shares were newly granted under the Post-IPO Restricted Share Award Scheme, with **88,000** shares vested and **157,037** shares lapsed[91](index=91&type=chunk)[92](index=92&type=chunk) [Use of Proceeds](index=42&type=section&id=Use%20of%20Proceeds) As of June 30, 2024, approximately **HKD 1.888 billion** (about **92.5%**) of the **HKD 2.043 billion** net proceeds from the Global Offering have been utilized, primarily for R&D and commercialization of core products KN046 and KN026. Approximately **HKD 39.4 million** of the **HKD 376 million** net proceeds from the 2023 Top-up Placement have been utilized, mainly for clinical trials of the ADC pipeline Use of Net Proceeds from Global Offering (As of June 30, 2024) | Purpose | Allocated Amount (HKD Millions) | Utilized Amount (HKD Millions) | Unutilized Amount (HKD Millions) | | :--- | :--- | :--- | :--- | | KN046 R&D and Commercialization | 1,021.3 | 947.7 | 73.6 | | KN026 R&D and Commercialization | 408.5 | 328.0 | 80.5 | | KN019 R&D | 102.1 | 102.1 | 0.0 | | Construction of New Suzhou Facilities | 306.4 | 306.4 | 0.0 | | Working Capital, etc. | 204.3 | 204.3 | 0.0 | | **Total** | **2,042.5** | **1,888.4** | **154.1** | Use of Net Proceeds from Top-up Placement (As of June 30, 2024) | Purpose | Allocated Amount (HKD Millions) | Utilized Amount (HKD Millions) | Unutilized Amount (HKD Millions) | | :--- | :--- | :--- | :--- | | JSKN003 Clinical Trials | 301.0 | 30.4 | 270.6 | | JSKN016 Clinical Development | 37.6 | 8.4 | 29.2 | | General Corporate Purposes | 37.6 | 0.6 | 37.0 | | **Total** | **376.2** | **39.4** | **336.8** | [Condensed Consolidated Financial Statements](index=45&type=section&id=Condensed%20Consolidated%20Financial%20Statements) [Principal Financial Statements and Notes](index=45&type=section&id=Principal%20Financial%20Statements%20and%20Notes) This section contains the condensed consolidated financial statements and related notes for the six months ended June 30, 2024, reviewed by Deloitte. The statements show total revenue of **RMB 174 million** and a loss for the period of **RMB 44.9 million**. Notes provide detailed explanations of accounting policies, revenue composition, various expenses, asset and liability positions, share-based payments, and related party transactions [Note 3: Revenue and Segment Information](index=54&type=section&id=Note%203%3A%20Revenue%20and%20Segment%20Information) The company's revenue primarily derives from drug sales and royalties, license fees, and provision of R&D goods. The company operates as a single reportable business segment. During the reporting period, three major customers contributed over **10%** of total revenue - The Group's business is managed and assessed as a single segment, with the vast majority of non-current assets located in China[123](index=123&type=chunk)[124](index=124&type=chunk) Major Customer Revenue Contribution (For the Six Months Ended June 30, 2024) | Customer | Revenue (RMB Thousands) | | :--- | :--- | | Customer A | 90,643 | | Customer B | 42,563 | | Customer C | 35,634 | [Note 16: Bank Borrowings](index=64&type=section&id=Note%2016%3A%20Bank%20Borrowings) As of June 30, 2024, the company's total bank borrowings amounted to **RMB 320 million**, an increase from **RMB 250 million** at the end of 2023. Of this, **RMB 200 million** were secured borrowings, with an effective annual interest rate ranging from **2.50%** to **2.87%** Bank Borrowings Composition (RMB Thousands) | Type | June 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Secured Bank Borrowings | 200,000 | 200,000 | | Unsecured Bank Borrowings | 120,000 | 50,000 | | **Total** | **320,000** | **250,000** | - Secured bank borrowings are collateralized by the Group's property, plant, and land use rights[150](index=150&type=chunk)[171](index=171&type=chunk) [Note 17 & 18: Share Capital and Share-based Payments](index=65&type=section&id=Note%2017%20%26%2018%3A%20Share%20Capital%20and%20Share-based%20Payments) During the reporting period, **80,000** ordinary shares were issued due to the exercise of share options. **1.18 million** new share options were granted under the Post-IPO Share Option Scheme, with fair value calculated using a binomial model. **130,000** award shares were newly granted under the Restricted Share Award Scheme. The notes detail the changes in each scheme and valuation model parameters - As of June 30, 2024, the total number of ordinary shares issued by the company was **964,923,807**[153](index=153&type=chunk) - The **1.18 million** share options newly granted on April 23, 2024, had an estimated total fair value of **HKD 2,048,689**, calculated using a binomial option pricing model[160](index=160&type=chunk)[161](index=161&type=chunk) - During the reporting period, unvested restricted shares changed from **1,051,068** at the beginning of the period to **936,031** at the end of the period[166](index=166&type=chunk)

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告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不就因本公告全部或任何部分內容所產生或因依 賴該等內容而引致的任何損失承擔任何責任。 期內其他全面收益（開支） 其後可重新分類至損益的項目： 換算海外業務產生之匯兌差額 282 (572) 期內全面開支總額 (44,614) (40,434) 1 ALPHAMAB ONCOLOGY 康寧傑瑞生物製藥 （於開曼群島註冊成立的有限公司） （股份代號：9966） 截至2024年6月30日止六個月中期業績公告 康寧傑瑞生物製藥（「本公司」，連同其附屬公司統稱「本集團」）董事（「董事」）會 （「董事會」）欣然宣佈本集團截至2024年6月30日止六個月（「報告期間」）的未經審 核簡明綜合業績，連同截至2023年同期的比較數字。 於本公告內，「我們」及「我們的」指本公司，並在文義另有所指時指本集團。本公 告所載若干數額及百分比數字已經四捨五入調整或以四捨五入取至小數點後一位 或兩位數。任何表格、圖表或其他地方所示總額與所列數額總和的任何差異乃因 四捨五入所致。 財務摘要 | --- | --- | | ...

Pipeline and Product Development - The company has a diverse pipeline including monoclonal antibodies, bispecific antibodies, and ADCs, with one product approved and three in late-stage clinical trials[5]. - KN046, a bispecific antibody targeting PD-L1 and CTLA-4, is undergoing approximately 20 clinical trials across more than 10 tumor types, showing promising safety and efficacy results[5]. - KN026, a next-generation anti-HER2 bispecific antibody, has received IND approval for a Phase III trial in HER2-positive breast cancer and has shown good preliminary efficacy in heavily treated patients[6]. - KN035, an innovative anti-tumor immunotherapy, is the first subcutaneously administered PD-L1 inhibitor globally and has received breakthrough therapy designation for certain cancer treatments[7]. - The company is actively seeking collaboration opportunities for clinical trials to enhance the efficacy of KN046[5]. - Recent clinical trial results for KN046 were presented at the 2023 ESMO conference, demonstrating its effectiveness in various cancer types[5]. - The company is advancing its late-stage clinical trials for dual antibody products, including KN046 for advanced squamous non-small cell lung cancer and pancreatic cancer, and KN026 for HER2-positive breast and gastric cancers[14]. - The JSKN003 product, a HER2-targeted bispecific antibody-drug conjugate, has shown preliminary efficacy and good tolerability in Phase I clinical trials in Australia[15]. - The company has received breakthrough therapy designation for the HER2-positive gastric cancer indication of KN026 in combination with chemotherapy[14]. - The clinical trial for JSKN033, a subcutaneous ADC combination product, has been approved in Australia and is set to begin patient dosing by March 26, 2024[15]. - The company is focusing on expanding indications and combination therapies for KN046, KN026, JSKN003, and exploring new products like JSKN033 and JSKN016[15]. - The company achieved significant progress in its drug pipeline, particularly with KN046, which showed promising results in multiple clinical trials[31]. - In 2023, the independent data monitoring committee recommended the continuation of the Phase III trial for KN046 in combination with platinum-based chemotherapy for advanced NSCLC patients[31]. - The company plans to further explore the efficacy of KN046 in various cancer types, with results presented at the 2023 ESMO conference[32]. - In May 2023, KN026 combined with docetaxel received IND approval for a Phase III clinical trial as a first-line treatment for HER2-positive recurrent or metastatic breast cancer (BC) from the National Medical Products Administration (NMPA)[33]. - As of September 15, 2023, the clinical trial of KN026 combined with docetaxel showed a median progression-free survival (PFS) of 27.7 months and a 24-month overall survival (OS) rate of 84.1%, with no new safety signals observed[33]. - In June 2023, positive results were reported from the ongoing ENVASARC Phase II trial of KN035, showing double-digit objective response rates and good tolerability[34]. - In August 2023, IND approval was granted for a Phase III trial of KN035 in resectable non-small cell lung cancer (NSCLC) patients, with the first patient dosed in December 2023[34]. - In November 2023, KN019's subcutaneous formulation received IND approval from the NMPA for clinical development[35]. - Encouraging PFS and OS benefits were reported in the Phase II clinical trial of KN046 combined with albumin-bound paclitaxel for first-line treatment of advanced TNBC, with results published in Nature Communications in February 2024[41]. - The clinical trial for JSKN016, targeting advanced malignant solid tumors, received implied approval from the National Medical Products Administration (NMPA) for clinical research in March 2024[41]. - Results from the Phase II clinical trial of KN046 combined with chemotherapy for first-line treatment of metastatic NSCLC were published in Cell Reports Medicine in March 2024[41]. - The latest results from the Phase I clinical trial of JSKN003 for HER2-expressing advanced solid tumors showed good tolerability and safety, with low incidence of hematologic toxicity and interstitial lung disease (ILD), presented at the AACR Annual Meeting in April 2024[41]. Financial Performance - Total revenue for 2023 increased by 31.12% compared to 2022, reaching 195.55 million RMB from the product KN035, a subcutaneous PD-L1 inhibitor, which grew by 32.54%[14]. - The total loss for 2023 decreased by 35.35% compared to the previous year, indicating improved financial health[14]. - The company reported a revenue of approximately $206.3 million for the year, reflecting a significant increase compared to the previous year[20]. - The company reported a significant increase in revenue, achieving a total of $150 million for the fiscal year, representing a 25% year-over-year growth[23]. - The company anticipates a revenue growth of 15% in the next fiscal year, driven by new product launches and increased market penetration[20]. - The company provided guidance for the next fiscal year, projecting revenue growth of 30% to $195 million[25]. - The company reported a user base growth of 25% year-over-year, indicating strong demand for its products[20]. - The company reported a pre-tax loss of RMB 210,593,000 for 2023, an improvement from a loss of RMB 325,722,000 in 2022[28]. - The company reported a total comprehensive expenses for the year ended December 31, 2023, were RMB 211.4 million, down from RMB 326.2 million in the previous year, indicating a reduction of approximately 35.1%[50]. - The company recorded pharmaceutical sales and licensing revenue of RMB 195.6 million for the year ended December 31, 2023, compared to RMB 147.5 million in the previous year, marking an increase of about 32.5%[51]. - The company reported a total compensation cost incurred for the year ended December 31, 2023, was RMB 189.3 million, compared to RMB 192.0 million for the year ended December 31, 2022[146]. Research and Development - The company has a strong R&D track record supported by proprietary technologies and expertise[4]. - The company has allocated a budget of $50 million for research and development in the upcoming fiscal year, focusing on innovative cancer therapies[19]. - The company plans to optimize manufacturing processes and technologies to enhance product quality and reduce costs[49]. - The company has developed proprietary platforms for various forms of protein constructs, enhancing its R&D and manufacturing capabilities, with a new facility expected to exceed a production capacity of 40,000L[46]. - The company emphasizes the importance of AI and new drug development engineering trends for future growth[14]. - The company is focusing on partnerships with leading research institutions to accelerate innovation in cancer therapies[23]. - The company has established strategic partnerships with leading research institutions to accelerate the development of new therapies[19]. - The company is committed to maintaining compliance with international regulatory standards, ensuring the safety and efficacy of its products[19]. Market Expansion and Strategy - The company continues to expand its market presence through innovative product development and strategic partnerships[4]. - The company is actively pursuing market expansion strategies, particularly in the Asia-Pacific region, to increase its market share[19]. - The company plans to launch new products in 2024, including KN035, which is expected to enhance its competitive position in the oncology market[22]. - The company is expanding its market presence in Europe, targeting a 15% market share by the end of 2025[23]. - The company plans to expand its commercialization team to cover major provinces and cities in China, particularly those with higher disposable income levels, as more products and indications are expected to be approved[47]. Corporate Governance and Compliance - The company has adopted the principles and code provisions of the Corporate Governance Code as a benchmark for its governance practices[93]. - As of December 31, 2023, the company has complied with all applicable code provisions of the Corporate Governance Code, except for the separation of the roles of Chairman and CEO[93]. - The board consists of two executive directors and three independent non-executive directors as of December 31, 2023[95]. - The company has established an insider information policy to comply with its obligations under the Securities and Futures Ordinance and Listing Rules[94]. - The board believes that having the same individual serve as both Chairman and CEO enhances the consistency of leadership and strategic planning[96]. - The company will continue to review and monitor its corporate governance practices to ensure compliance with the Corporate Governance Code[93]. - Independent non-executive directors have confirmed their independence in accordance with the Listing Rules[99]. - The nomination committee is responsible for reviewing the composition of the board and recommending suitable candidates for directorship[101]. - The board of directors is responsible for major decisions, including approving and overseeing key policies and overall strategies, internal controls, and risk management systems[102]. - The audit committee consists of three independent non-executive directors, ensuring compliance with the listing rules and overseeing the group's financial information[104]. Employee and Corporate Culture - The company emphasizes employee-centricity, continuous innovation, and aims to solve the pain of cancer patients[92]. - The company continues to strengthen its cultural framework, promoting corporate culture and requiring all employees to consolidate it[92]. - New employees are required to participate in onboarding training to better understand the corporate culture, structure, and policies[92]. - The company invites external experts to train management personnel to enhance their knowledge and management skills[92]. - The company has a zero-tolerance policy for discrimination based on gender, age, race, nationality, and disability, ensuring equal employment opportunities[116]. - The company aims to enhance employee diversity in 2024, aiming for a more balanced representation[116]. - The board believes that corporate culture aligns with the company's mission, values, and strategies[92]. - The company has implemented various stock option plans and restricted share award plans to incentivize employees, aligning compensation with qualifications, industry experience, position, and performance[81]. Shareholder Relations - The company has adopted a shareholder communication policy to enhance effective communication with shareholders and facilitate their participation in the company's operations[133]. - Shareholders can submit inquiries to the board via written communication, with specific contact details provided for the joint company secretaries[132]. - Shareholders can convene special meetings if the board does not respond to requests within 21 days, with the company covering reasonable costs incurred by the requesters[130]. - There are no provisions allowing shareholders to propose new resolutions at general meetings, but they can call special meetings to achieve this[131]. Risk Management - The board is responsible for risk management and internal control systems, ensuring their effectiveness to manage risks associated with achieving business objectives[124]. - The company encourages employees to adopt proactive risk management approaches, enhancing the risk awareness culture within the organization[125]. - The anti-corruption policy is part of the corporate governance framework, ensuring compliance with applicable anti-corruption laws and regulations[127]. - The internal control system has been reviewed by internal consultants and auditors, with no major deficiencies identified, confirming its effectiveness during the reporting period[125]. Environmental and Social Responsibility - The company is committed to sustainable and environmentally friendly development, complying with relevant environmental laws and regulations in China[143]. - The company recognizes the importance of stakeholder relationships for its success and is committed to sustainable practices[149].

Financial Performance - The total comprehensive expenses for the year amounted to RMB 211,387,000, a decrease from RMB 326,162,000 in the previous year, reflecting a reduction of approximately 35%[2] - The company reported a pre-tax loss of RMB 210,593,000 for the year, compared to a pre-tax loss of RMB 325,722,000 in the previous year, indicating an improvement of about 35%[2] - Total revenue for the year ended December 31, 2023, was RMB 218.8 million, an increase of 30.9% from RMB 166.8 million for the year ended December 31, 2022[21] - The company reported a net loss of RMB 210,593 million for the year ended December 31, 2023, an improvement from a net loss of RMB 325,722 million in 2022[51] - The company reported a loss attributable to shareholders of RMB 210,593,000 for 2023, compared to a loss of RMB 325,722,000 in 2022, representing a 35.3% improvement year-over-year[77] Assets and Liabilities - Non-current assets totaled RMB 578,583,000, while current assets were RMB 1,558,530,000, showing an increase in current assets from RMB 1,494,530,000 in the previous year[3] - The net asset value increased to RMB 1,672,112,000 from RMB 1,557,672,000, representing a growth of approximately 7.3%[3] - Total assets as of December 31, 2023, were RMB 3,428.113 million, compared to RMB 3,226.530 million in 2022, showing an increase of 6.2%[52] - Total liabilities decreased to RMB 119,888,000 in 2023 from RMB 135,361,000 in 2022, reflecting a reduction of approximately 11.4%[87] - The company had bank borrowings of RMB 250 million as of December 31, 2023, down from RMB 325 million in 2022, with interest rates ranging from 2.70% to 2.87%[44] Research and Development - The company achieved significant progress in its drug pipeline, including positive results from multiple clinical trials for KN046 and KN026, with promising efficacy and safety signals reported[4][6] - The company reported a significant increase in research and development (R&D) expenses, reflecting its commitment to advancing its drug development pipeline[2] - Research and development expenses decreased to RMB 407.5 million, down 12.9% from RMB 468.2 million in 2022, due to some existing projects nearing completion[29] - The company is committed to ongoing research and development in oncology biopharmaceuticals, with plans to expand its product pipeline in the coming years[60] Clinical Trials and Drug Development - In the KN046 clinical trials, encouraging overall survival (OS) benefits were observed in patients with advanced non-small cell lung cancer (NSCLC) who previously failed epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors[5] - The independent data monitoring committee recommended the continuation of the KN046 trial for advanced pancreatic ductal adenocarcinoma, indicating ongoing positive developments[5] - The company plans to expand its clinical trials for KN026, with new drug clinical trial approvals received from the National Medical Products Administration of China[6] - In November 2023, KN026 received breakthrough therapy designation from the National Medical Products Administration (NMPA) for treating HER2-positive GC/GEJ patients who failed first-line standard treatment[7] - In June 2023, TRACON Pharmaceuticals reported positive results from the ongoing KN035 ENVASARC Phase II trial, demonstrating double-digit objective response rates and good tolerability[7] Revenue and Sales - Pharmaceutical sales and licensing income amounted to RMB 195.6 million, up 32.5% from RMB 147.5 million in the previous year, primarily driven by sales of the KN035 product[23] - Revenue from drug sales and licensing fees was RMB 195,551 thousand in 2023, compared to RMB 147,544 thousand in 2022, reflecting a year-over-year increase of about 32.5%[60] - Sales revenue from KN035 products to Sichuan Shilukangrui Pharmaceutical reached RMB 128,379,000 in 2023, compared to RMB 86,040,000 in 2022, reflecting a growth of approximately 49%[61] Corporate Governance and Management - The board includes Dr. Xu Ting as Chairman and Executive Director, highlighting leadership continuity[107] - The executive team also comprises Ms. Liu Yang as Executive Director, indicating a diverse leadership structure[107] - Independent non-executive directors include Dr. Guo Zijian, Mr. Wei Cheng, and Mr. Wu Dong, ensuring governance and oversight[107] - The board's composition reflects a commitment to diverse perspectives in decision-making[107] Future Outlook and Strategy - The company aims to enhance its market presence through strategic clinical trial advancements and potential future product launches[4][6] - The company is exploring market expansion opportunities and potential mergers and acquisitions to enhance its competitive position in the oncology sector[60] - The company believes that the next decade will see significant advancements in the development of innovative therapeutic biologics in China[19] Miscellaneous - The company has no significant contingent liabilities or major litigation that could adversely affect its financial position as of December 31, 2023[48] - The company did not declare any dividends for the year ending December 31, 2023, consistent with 2022[93] - The annual general meeting is scheduled for June 12, 2024, to discuss shareholder matters[105]

Financial Performance - The company reported a revenue of $150 million for Q2 2023, representing a 25% increase year-over-year[3]. - Revenue for the six months ended June 30, 2023, was RMB 136,465 thousand, a significant increase from RMB 53,569 thousand in the same period of 2022, representing a growth of 154.5%[20]. - Total revenue for the six months ended June 30, 2023, was RMB 136.5 million, a significant increase from RMB 53.6 million for the same period in 2022, representing a growth of approximately 154.3%[32]. - Revenue from drug sales and licensing fees amounted to RMB 117.0 million, up from RMB 53.5 million in 2022, indicating a year-over-year increase of about 118.5%[34]. - The company reported a pre-tax loss of RMB 39,862 thousand for the first half of 2023, a substantial improvement from a loss of RMB 147,309 thousand in the same period of 2022, marking a reduction of 72.9%[20]. - The company reported a loss of RMB 39,862,000 for the six months ended June 30, 2023, significantly improved from a loss of RMB 147,309,000 in the same period of 2022, representing a reduction of 72.9%[146]. Product Development and Pipeline - The company provided guidance for Q3 2023, expecting revenue to be between $160 million and $170 million, indicating a growth of 20% to 30% compared to Q3 2022[3]. - New product launches included two innovative therapies, which are expected to contribute an additional $50 million in revenue by the end of 2023[3]. - The management highlighted a strong pipeline with five products in late-stage clinical trials, projected to enter the market by 2025[3]. - The company reported a strong pipeline with one product approved by the National Medical Products Administration and three in late-stage clinical trials[12]. - KN046, a bispecific antibody targeting PD-L1 and CTLA-4, is undergoing approximately 20 clinical trials across more than 10 tumor types, showing promising safety and efficacy[12]. - The company has initiated pivotal clinical trials for KN046 in NSCLC and PDAC, seeking collaboration opportunities for combination therapies[12]. - The company is focused on expanding its proprietary biopharmaceutical platform in bispecific and protein engineering[11]. - The company aims to provide world-class innovative biopharmaceuticals through its drug discovery and development capabilities[11]. - The company has a differentiated internal pipeline consisting of monoclonal antibodies, bispecific antibodies, and antibody-drug conjugates[12]. - The company continues to seek strategic partnerships to enhance the development of its product candidates[12]. Research and Development - The company invested $20 million in new technology development, focusing on improving production efficiency by 40%[3]. - Research and development expenses decreased to RMB 194,681 thousand from RMB 216,399 thousand year-over-year, reflecting a reduction of approximately 10%[20]. - The total R&D expenses for the six months ended June 30, 2023, amounted to RMB 194,681,000, a decrease from RMB 216,399,000 in the same period of 2022[185]. - The company has developed proprietary platforms for various antibody formats, enhancing its internal R&D and manufacturing capabilities[30]. Market Expansion and Strategy - The company is expanding its market presence in Europe, targeting a 15% market share by the end of 2024[3]. - A strategic acquisition was completed, enhancing the company's R&D capabilities and expected to generate $10 million in cost synergies annually[3]. - Future outlook remains positive, with an anticipated annual growth rate of 25% over the next three years[3]. - The company aims to expand its commercialization team across major provinces in China, particularly in economically developed areas[31]. Financial Position and Assets - Total assets as of June 30, 2023, were RMB 2,328,389 thousand, up from RMB 2,117,531 thousand at the end of 2022, showing an increase of 9.9%[21]. - The net asset value increased to RMB 1,846,820 thousand as of June 30, 2023, compared to RMB 1,557,672 thousand at the end of 2022, reflecting a growth of 18.6%[21]. - Cash and cash equivalents increased from RMB 1,069.2 million as of December 31, 2022, to RMB 1,136.3 million as of June 30, 2023, while term deposits with maturities over three months rose significantly from RMB 247.9 million to RMB 445.3 million[54]. - The company reported total employee compensation costs of RMB 85.3 million for the six months ended June 30, 2023, compared to RMB 86.7 million for the same period in 2022[69]. Corporate Governance and Compliance - The company has complied with all applicable corporate governance code provisions, except for the separation of the roles of Chairman and CEO[82]. - The audit committee reviewed the unaudited condensed consolidated financial statements for the six months ended June 30, 2023[86]. - The company will continue to review and monitor its corporate governance practices to ensure compliance with the corporate governance code[82]. Stock Options and Share Issuance - The company has adopted two pre-IPO stock option plans, with a total of 27,082,725 options granted, of which 63,000 were exercised and 97,750 were forfeited during the reporting period[88]. - The total number of options that will vest in 2024 is 1,400,000, with additional vesting amounts scheduled for 2025 and 2026[95]. - The company issued 25,000,000 ordinary shares during the reporting period, increasing the total issued shares to 964,779,387 as of June 30, 2023[166]. - The company raised approximately HKD 376.2 million from the placement and subscription of 25 million shares at HKD 15.22 per share in February 2023[25].

Financial Performance - For the six months ended June 30, 2023, the company reported revenue of RMB 136,465 thousand, a significant increase from RMB 33,165 thousand in the same period of 2022, representing a growth of approximately 311%[2] - The gross profit for the same period was RMB 103,300 thousand, compared to RMB 42,979 thousand in 2022, indicating a growth of about 140%[2] - The company incurred a pre-tax loss of RMB 39,862 thousand for the period, an improvement from a loss of RMB 147,309 thousand in the previous year, reflecting a reduction of approximately 73%[2] - Total revenue for the six months ended June 30, 2023, was RMB 136.5 million, a significant increase from RMB 53.6 million for the same period in 2022, representing a growth of approximately 154.3%[16] - The company recorded other income of RMB 43.0 million for the six months ended June 30, 2023, compared to RMB 21.7 million in the same period of 2022, marking an increase of approximately 97.2%[16] - The company reported a net loss of RMB 39.862 million for the period, an improvement from a net loss of RMB 147.309 million in the same period last year[48] - The total comprehensive loss for the period was RMB 40.434 million, compared to RMB 147.318 million in the previous year, indicating a significant reduction in losses[48] Asset and Liquidity Position - Non-current assets decreased to RMB 605,652 thousand from RMB 623,001 thousand year-over-year, while current assets increased to RMB 1,722,737 thousand from RMB 1,494,530 thousand, indicating a stronger liquidity position[3] - The net asset value increased to RMB 1,846,820 thousand from RMB 1,557,672 thousand, reflecting a growth of approximately 18.5% year-over-year[3] - The current ratio improved to 6.59 as of June 30, 2023, compared to 3.88 at the end of 2022, indicating better liquidity[42] - Cash and cash equivalents increased from RMB 1,069.2 million as of December 31, 2022, to RMB 1,136.3 million as of June 30, 2023, while time deposits with maturities over three months surged from RMB 247.9 million to RMB 445.3 million[34] Research and Development - The company achieved significant milestones in its drug pipeline, including the initiation of clinical trials for JSKN003 and KN052, with KN052's preclinical data showing superior anti-tumor activity compared to control antibodies[4][5] - The company plans to present six different research advancements related to KN046 and KN026 at the upcoming European Society for Medical Oncology conference in October 2023[6][7] - The new drug application (NDA) for KN046 is expected to be submitted in 2024, and for KN026 in 2025, highlighting the company's future growth prospects[15] - The company has a diverse pipeline of products, including one approved product and three in late clinical stages, indicating a robust development strategy[11] - The company is making steady progress in drug development and exploring strategic collaborations with business partners, aiming to achieve significant clinical development milestones[79] Production and Capacity Expansion - The company completed the expansion of its production facility to a capacity of 6,000L, which is expected to be used for clinical trial drug production in the second half of 2023[8] - The company is planning further expansion of its production capacity, with a design capacity exceeding 40,000L for the next phase of construction[8] - The company has established advanced manufacturing capabilities with a projected capacity exceeding 40,000L, enhancing its production capabilities[14] Strategic Collaborations and Partnerships - A strategic collaboration was established with Simi (Shanghai) Biotechnology Co., Ltd. to explore the combination therapy of KN052 and personalized mRNA tumor vaccine SWP1001 for certain solid tumors[4] - The company continues to explore strategic partnerships and collaborations to enhance its market presence and product offerings[51] - The company granted a license to Jinmant Biotechnology for the development and commercialization of KN026, with a non-refundable upfront payment of RMB 150 million and potential milestone payments totaling RMB 850 million[58] Expenses and Cost Management - Research and development expenses for the six months ended June 30, 2023, were RMB 194.7 million, down from RMB 216.4 million in 2022, reflecting a decrease of approximately 10.0%[16] - Administrative expenses decreased to RMB 33.2 million from RMB 44.1 million year-over-year, showing a reduction of about 24.0%[16] - Financing costs decreased from RMB 10.9 million for the six months ended June 30, 2022, to RMB 7.0 million for the same period in 2023, a reduction of 35.5%[28] Market and Sales Performance - For the six months ended June 30, 2023, the company recorded pharmaceutical sales and licensing income of RMB 117.0 million, compared to RMB 53.5 million for the same period in 2022, representing an increase of 118.5%[19] - Revenue from sales of the KN035 product to Sichuan Silu Kangrui Pharmaceutical amounted to RMB 71.5 million for the six months ended June 30, 2023, up from RMB 27.2 million in the same period of 2022, reflecting a growth of 162.5%[19] - The company recognized royalty income based on sales of RMB 45.5 million for the six months ended June 30, 2023, compared to RMB 25.4 million for the same period in 2022, marking an increase of 79.5%[19] Corporate Governance and Compliance - The company has adhered to all applicable corporate governance codes, except for a deviation regarding the separation of the roles of Chairman and CEO[82] - The company has established a set of insider information policies to comply with the Securities and Futures Ordinance and listing rules[83] Future Outlook - The company anticipates that the development of innovative therapeutic biologics will drive growth in the pharmaceutical industry over the next decade[79] - New policies in China are expected to accelerate drug development processes and enhance innovation standards in the pharmaceutical industry[79] Miscellaneous - There were no significant investments or acquisitions made during the six months ended June 30, 2023[43] - The company has not declared or recommended any dividends during the reporting period[71] - No significant events affecting the company occurred after June 30, 2023[88] - The interim report for the six months ending June 30, 2023, will be sent to shareholders in September 2023[88] - The company acknowledges the support and contributions from shareholders, management team, employees, business partners, and customers[89]