Core Insights - Lepu Biotech's MRG006A, a targeted GPC3 antibody-drug conjugate (ADC), has successfully completed the first patient enrollment in a Phase II clinical study for advanced hepatocellular carcinoma (HCC), marking it as the first GPC3-targeted ADC to enter Phase II globally [1][2] - MRG006A utilizes Lepu Biotech's Hi-TOPi ADC technology platform, which allows for precise targeting of GPC3-positive tumor cells, releasing toxins specifically within tumors to achieve targeted cell destruction [1] Group 1: Clinical Development - MRG006A is positioned as a significant innovation in the treatment of HCC, a prevalent malignancy where most patients are diagnosed at advanced stages, and treatment options are limited after first-line therapy failure [1] - The GPC3 antigen, which is expressed in 70%-80% of HCC cases but minimally in normal tissues, is considered a "golden" target for precision therapy [1] - Clinical data indicate that adverse reactions primarily involve liver function abnormalities and mild bone marrow suppression, which are manageable, supporting the feasibility of its clinical application [1] Group 2: Clinical Trial Results - In Phase I trials, MRG006A demonstrated promising results, with significant tumor shrinkage observed in GPC3-positive patients, exceeding expectations during dose escalation studies [2] - The advancement of the Phase II study for MRG006A represents a crucial breakthrough in Lepu Biotech's ADC pipeline and has the potential to address unmet clinical needs in HCC treatment [2]

Group 1 - A-shares and Hong Kong stocks in the innovative pharmaceutical sector have rebounded, with significant gains in related stocks and ETFs [1][3][5] - The largest medical ETF in A-shares (512170) saw a trading volume of 589 million yuan, recovering 1.34% on the day [1] - The innovative drug sector is experiencing a collective rise, with notable stocks like Huahai Pharmaceutical increasing by 7.59% [3] Group 2 - The Hong Kong innovative drug ETF (520880) rose by 2.12%, with 35 out of 37 constituent stocks gaining, led by Green Leaf Pharmaceutical with an 8.31% increase [5][7] - Recent funding trends indicate a significant inflow into the innovative drug sector, with over 1.29 billion yuan added in the last three days [7] - Upcoming catalysts include the European Society for Medical Oncology (ESMO) annual meeting, which may showcase significant research results from Chinese innovative drugs [7] Group 3 - Investment strategies suggest focusing on innovative drugs, with specific ETFs like the Hong Kong innovative drug ETF (520880) and the A-share drug ETF (562050) highlighted for their potential [8] - The medical ETF (512170) is noted for its inclusion of CXO companies, which account for 26.77% of its weight [8] - The medical ETF is the largest in the market, with a scale of 26.4 billion yuan, while the drug ETF is the only one tracking the China Pharmaceutical Index [9]

Group 1 - The article discusses the innovative approach of a company in Wuhan, Hubei, which is utilizing viruses to treat cancer, highlighting its potential in the biotechnology sector [1] - The company is preparing for an IPO, indicating strong investor interest and potential for growth in the market [1] - The involvement of Lepu Biopharma as an investor suggests confidence in the company's technology and future prospects [1] Group 2 - The article emphasizes the significance of the biotechnology industry in developing novel cancer therapies, reflecting a growing trend towards personalized medicine [1] - It notes the increasing investment in innovative drug development, which is crucial for advancing treatment options for cancer patients [1] - The potential market size for such therapies is substantial, indicating a lucrative opportunity for investors in the biotech field [1]

股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年9月30日 狀態: 新提交 FF301 II. 已發行股份及/或庫存股份變動 | 1. 股份分類 | 普通股 | 股份類別 | H | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 02157 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 1,804,439,838 | RMB | | 1 RMB | | 1,804,439,838 | | 增加 / 減少 (-) | | | | | | RMB | | | | 本月底結存 | | | 1,804,439,838 | RMB | | 1 RMB | | 1,804,439,838 | 本月底法定/註冊股本總額： RMB 1,804,439,838 FF301 致：香港交易及結算所有限公司 第 1 頁 共 10 頁 ...

Core Viewpoint - The potential imposition of a 100% tariff on imported brand and patented drugs by the Trump administration starting October 1, 2025, has raised concerns among pharmaceutical companies, particularly those in China, leading to a decline in their stock prices [2][3]. Group 1: Impact on Pharmaceutical Companies - The announcement of the tariff has caused significant declines in the stock prices of Chinese pharmaceutical companies, with Heng Rui Pharmaceutical dropping 3.03% in A-shares and 2.23% in Hong Kong shares, and BeiGene falling 4.38% in A-shares and 1.55% in Hong Kong shares [2]. - The Hang Seng Innovative Drug Index (HSIDI) fell by 2.37%, with notable declines in stocks such as Fosun Pharma, which dropped 5.82%, and 3SBio, which fell by 5.34% [3]. - Industry experts suggest that the impact of the tariff on Chinese pharmaceutical companies may be limited, as many are focused on generic drugs and active pharmaceutical ingredients (APIs) [4]. Group 2: Industry Perspectives - Some industry leaders believe that the tariff policy may not be implemented as proposed, citing the high cost of drugs in the U.S. and the potential for political changes in future administrations [4][5]. - Companies like Heng Rui Pharmaceutical indicated that their current exports primarily consist of generics and APIs, suggesting minimal impact from the proposed tariffs [4]. - Other companies, such as Lepu Biopharma, noted that their licensing partnerships would shield them from significant effects [5]. Group 3: U.S. Policy Context - The Trump administration has previously threatened to impose tariffs on imported drugs, with discussions around a 200% tariff and subsequent smaller tariffs leading to a potential increase over time [6][7]. - Major multinational pharmaceutical companies have responded to the tariff threats by committing to significant investments in U.S. manufacturing, with companies like Novartis and Roche pledging $23 billion and $50 billion respectively over the next five years [8].

Core Viewpoint - The potential implementation of a 100% tariff on all brand-name and patented drugs by the U.S. government starting October 1, 2025, unless companies are building drug manufacturing plants in the U.S. [2] Group 1: Market Reaction - Pharmaceutical stocks in multiple markets, including China, Japan, and South Korea, experienced a collective decline following the announcement [3] - Specific declines included a 3.03% drop in Hengrui Medicine (600276.SH/01276.HK) A-shares and a 2.23% drop in Hong Kong shares, while BeiGene (ONC.NASDAQ/06160.HK/688235.SH) saw a 4.38% drop in A-shares and a 1.55% drop in Hong Kong shares [3] - The Hang Seng Innovative Drug Index (HSIDI) fell by 2.37%, with notable declines in stocks such as Fosun Pharma (600196.SH/02196.HK) down 5.82% and 3SBio (01530.HK) down 5.34% [4] Group 2: Industry Perspectives - Industry experts suggest that Chinese pharmaceutical companies aiming to expand internationally need to consider the potential implementation of this policy and explore possible solutions [5] - Some executives believe that the high cost of drugs in the U.S. may hinder the realization of this policy [5] - Hengrui Medicine's executive noted that the impact of the potential policy would be limited as their exports mainly consist of generic drugs and APIs [5] - Other companies, such as Lepu Biopharma, indicated that their licensing partnerships would not be significantly affected [5] - Investors pointed out that this is a political issue that could change with future administrations, suggesting that while there may be short-term negative impacts, the long-term effects may not be significant [5] Group 3: Historical Context - Historically, pharmaceuticals have been excluded from tariff lists, but President Trump has repeatedly threatened to impose tariffs on imported drugs this year [5] - The Trump administration initiated a "232 investigation" under the Trade Expansion Act of 1962, which allows for tariffs if imports threaten national security [6] - Previous statements from Trump indicated plans for escalating tariffs on imported drugs, with initial small tariffs leading to potential increases up to 250% [7] Group 4: Investment Commitments - In response to the tariff threats, several multinational pharmaceutical companies have committed to investing in U.S. manufacturing facilities, with significant investments announced by companies like Novartis, Roche, Sanofi, and AstraZeneca [8] - Notably, Novartis and Roche pledged $23 billion and $50 billion respectively over five years, while AstraZeneca committed to a $50 billion investment by 2030 [8]

Core Viewpoint - The stock of Lepu Biopharma-B (02157.HK) experienced a significant increase of over 4% in early trading on September 25, reaching a price of 7.34 HKD with a trading volume of 30.16 million HKD [2] Company Summary - Lepu Biopharma-B's stock rose by 4.11% to 7.34 HKD during early trading [2] - The trading volume for the stock was reported at 30.16 million HKD [2]

消息面上，9月19日，CDE官网公示，乐普生物旗下EGFR靶向ADC药物MRG003拟被纳入突破性疗法认 定，适应症为联合普特利单抗(PD-1单抗)治疗既往接受过铂类及PD-1/PD-L1抑制剂治疗失败的复发或转 移性鼻咽癌。 据悉，MRG003是目前全球研发进展领先的EGFR ADC药物，此前已获得CDE授予的突破性治疗药物认 定与优先审评资格，以及FDA授予的孤儿药资格、快速通道资格和突破性疗法认定。2024年9月，乐普 生物首次提交该药用于鼻咽癌的上市申请，后因需补充资料主动撤回，并于今年3月重新提交，目前已 被纳入优先审评程序，单药用于特定复发/转移性鼻咽癌患者治疗。 乐普生物-B(02157)早盘涨超4%，截至发稿，涨4.11%，报7.34港元，成交额3016万港元。 ...

Core Viewpoint - Lepu Biopharma-B (02157) saw a significant stock increase of over 4%, currently trading at 7.34 HKD, with a transaction volume of 30.16 million HKD, following the announcement of its drug MRG003 being considered for breakthrough therapy designation [1] Group 1: Drug Development and Regulatory Status - MRG003, an EGFR-targeted ADC drug developed by Lepu Biopharma, is proposed for breakthrough therapy designation for treating recurrent or metastatic nasopharyngeal carcinoma in patients who have previously failed platinum-based and PD-1/PD-L1 inhibitor treatments [1] - MRG003 is currently the leading EGFR ADC drug in global development, having previously received breakthrough therapy designation and priority review qualification from CDE, as well as orphan drug status, fast track designation, and breakthrough therapy designation from the FDA [1] - The company initially submitted the marketing application for MRG003 for nasopharyngeal carcinoma in September 2024 but withdrew it to provide additional information, and resubmitted it in March of this year, now included in the priority review process for specific recurrent/metastatic nasopharyngeal carcinoma patients [1]

[Company Information](index=3&type=section&id=Company%20Information) This section provides an overview of the company's governance structure, including board and committee members, professional advisors, and key office locations [Board of Directors and Supervisory Committee Members](index=3&type=section&id=Board%20of%20Directors%20and%20Supervisory%20Committee%20Members) This section lists the company's executive, non-executive, independent non-executive directors, and supervisory committee members, noting the appointment of Ms. Qin Yiran and the retirement of Mr. Yang Hongbing as non-executive directors - Executive Directors include Dr. Pu Zhongjie (Chairman) and Dr. Sui Ziye (General Manager)[5](index=5&type=chunk) - Non-executive Director Ms. Qin Yiran was appointed effective June 27, 2025, and Mr. Yang Hongbing retired on the same day[5](index=5&type=chunk) [Committee Members](index=3&type=section&id=Committee%20Members) This section details the composition of the Audit, Remuneration and Assessment, Nomination, and Strategy Committees, noting the retirement of Dr. Pu Zhongjie and appointment of Ms. Pu Jue to the Nomination Committee - The Audit Committee Chairman is Mr. Hua Fengmao[5](index=5&type=chunk) - The Nomination Committee Chairman is Mr. Zhou Demin, Ms. Pu Jue was appointed effective June 27, 2025, and Dr. Pu Zhongjie retired on the same day[5](index=5&type=chunk) [Professional Advisors and Offices](index=3&type=section&id=Professional%20Advisors%20and%20Offices) This section provides details on the company's joint company secretaries, authorized representatives, auditor, legal advisors, H-share registrar, principal place of business in Hong Kong, principal bankers, and head office in China - The auditor is Ernst & Young[5](index=5&type=chunk) - The company's head office and principal place of business in China are located at No. 651 Lianheng Road, Minhang District, Shanghai, China[7](index=7&type=chunk) [Financial Highlights](index=5&type=section&id=Financial%20Highlights) As of June 30, 2025, total assets were RMB 2,361,606 thousand, total liabilities RMB 1,649,811 thousand, and total equity RMB 711,795 thousand, with revenue significantly growing to RMB 465,942 thousand and operating income turning profitable at RMB 42,981 thousand Comparison of Financial Position as of June 30, 2025, and December 31, 2024 | Metric | June 30, 2025 (RMB Thousand) | December 31, 2024 (RMB Thousand) | | :--- | :--- | :--- | | Total Assets | 2,361,606 | 2,280,685 | | Total Liabilities | 1,649,811 | 1,598,882 | | Total Equity | 711,795 | 681,803 | Comparison of Profit or Loss for the Six Months Ended June 30, 2025, and Same Period in 2024 | Metric | June 30, 2025 (RMB Thousand) | June 30, 2024 (RMB Thousand) | | :--- | :--- | :--- | | Revenue | 465,942 | 133,283 | | Cost of Sales | (27,403) | (21,042) | | Gross Profit | 438,539 | 112,241 | | Operating Income / (Loss) | 42,981 | (184,036) | | Profit / (Loss) Before Income Tax | 29,302 | (196,966) | [Management Discussion and Analysis](index=6&type=section&id=Management%20Discussion%20and%20Analysis) This section provides an in-depth analysis of the company's operational performance, financial condition, product pipeline, R&D progress, and future strategic outlook [Overview](index=6&type=section&id=Overview) The company is an innovative biopharmaceutical enterprise focused on oncology, possessing comprehensive ADC technology and end-to-end capabilities, strategically developing multiple oncology product pipelines through innovation and partnerships for commercialization and global expansion - The company focuses on oncology, particularly targeted and immunotherapy, with integrated capabilities from drug discovery to GMP manufacturing[10](index=10&type=chunk) - The product pipeline includes one clinical/commercial-stage candidate, nine clinical-stage candidates, and three combination therapies, with several drugs granted Breakthrough Therapy Designation (BTD), Orphan Drug Designation (ODD), and Fast Track Designation (FTD) by the FDA and CDE[11](index=11&type=chunk) - Puyouheng® has completed full commercialization and is rapidly growing, while CMG901 and MRG007 have successfully entered into out-licensing partnerships, laying the foundation for future commercialization and global collaboration[12](index=12&type=chunk) [Product Pipeline](index=7&type=section&id=Product%20Pipeline) The company boasts a rich product pipeline, including various ADCs, oncolytic viruses, and cancer immunotherapies, with MRG003, MRG002, and Puyouheng® as core products, many of which are in key clinical stages and have received Breakthrough Therapy Designation Key Candidate Drugs and Development Status | Candidate Drug | Indication | Preclinical | Phase Ia | Phase Ib | Phase II | Pivotal/Phase III | NDA | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | MRG003* EGFR-targeted ADC | NPC second-line or above NPC | | | | | | | | MRG004A TF-targeted ADC | TF-positive advanced or metastatic solid tumors | | | US | | | | | MRG002* HER2-targeted ADC | BC HER2-high expression liver metastasis BC | | | | | | | | CMG901 CLDN18.2-targeted ADC | G/GEJ cancer and other solid tumors | | | | | Global | | | CG0070 Oncolytic Virus | BCG-unresponsive NMIBC | | | | | | | | Puyouheng® Anti-PD-1 mAb | Second-line or above MSI-H/dMMR solid tumors | | | | | | | - MRG003 for NPC treatment has been granted BTD, ODD, and FTD by the FDA, and BTD by the CDE[11](index=11&type=chunk) - Global rights for CMG901 have been licensed to AstraZeneca, and ex-Greater China rights for MRG007 have been licensed to ArriVent[12](index=12&type=chunk)[13](index=13&type=chunk) [Business Review](index=8&type=section&id=Business%20Review) During the reporting period, the company achieved significant revenue growth, driven by MRG007 out-licensing income and strong sales of core product Puyouheng®, alongside substantial R&D progress for multiple candidates, continuous innovation platform development, and steady manufacturing facility construction - The Group's total revenue was approximately **RMB 465.9 million**, a **3.5-fold increase** compared to the same period in 2024[14](index=14&type=chunk) - Licensing revenue was approximately **RMB 309.0 million**, primarily from the out-licensing of MRG007[14](index=14&type=chunk) - Puyouheng® sales revenue was approximately **RMB 150.6 million**, a **58.8% increase** compared to the same period in 2024[14](index=14&type=chunk) [Commercialization](index=8&type=section&id=Commercialization) The company achieved significant commercialization results, with substantial revenue growth, strong Puyouheng® sales, and successful out-licensing of MRG007, actively expanding its sales network and offering CDMO services using surplus capacity - As of June 30, 2025, the company completed bidding procedures in **28 provinces** across China, covering approximately **118 cities**[15](index=15&type=chunk) - Global exclusive license for MRG007 granted to ArriVent, entitling the company to up to **USD 1.2 billion** in upfront, milestone payments, and tiered royalties on net sales[16](index=16&type=chunk) - Puyouheng® was successfully included in the 2023 CSCO and CSGO guidelines, enhancing market recognition[16](index=16&type=chunk) [R&D Progress](index=9&type=section&id=R%26D%20Progress) The company's core candidate drugs achieved significant clinical development progress, with MRG003's NDA under review, MRG004A entering Phase III, and positive clinical data or regulatory advancements for MRG002, MRG001, MRG006A, MRG007, CMG901, and CG0070 - MRG003's NDA for R/M NPC treatment is under review by the NMPA CDE and has been granted priority review[18](index=18&type=chunk) - MRG004A entered Phase III clinical trials in August 2025, with Phase Ib data to be presented at the ESMO conference[20](index=20&type=chunk) - MRG007 received NMPA IND approval in June 2025 and entered an exclusive licensing agreement with ArriVent, securing a **USD 47 million** upfront payment and near-term milestone payments[28](index=28&type=chunk) - CG0070 received BTD from the CDE for treating recurrent or refractory BCG-unresponsive bladder cancer patients[31](index=31&type=chunk) [Innovation Platforms](index=13&type=section&id=Innovation%20Platforms) The company continuously invests in innovative technology platforms, including Hi-TOPi ADC, bispecific ADC, next-generation PD-1, and T-cell engager platforms, which have successfully developed candidate drugs with global first-in-class or best-in-class potential - The Hi-TOPi ADC platform has developed MRG006A (global first-in-class potential) and MRG007 (global best-in-class potential), both having received China IND approval[34](index=34&type=chunk) - Bispecific ADCs aim to expand the therapeutic scope for key indications such as lung cancer[36](index=36&type=chunk) - The T-cell engager platform (TOPAbody) aims to unleash T-cell potential by simultaneously activating TCR signaling and co-stimulatory pathways[36](index=36&type=chunk) [Manufacturing Facilities](index=14&type=section&id=Manufacturing%20Facilities) The company operates a 2,000L GMP-compliant bioreactor production line in Beijing, and its Shanghai Biotech Park, with a 12,000L total design capacity, has completed construction, with the R&D center already operational to meet future business needs - The Beijing manufacturing plant operates a **2,000L GMP-compliant** bioreactor production line, supporting clinical drug supply and CDMO services[37](index=37&type=chunk) - The Shanghai Biotech Park R&D center is operational, with a total designed production capacity of **12,000L**, and has obtained environmental assessment reports for mAb and ADC production[37](index=37&type=chunk) [Significant Events After Reporting Period](index=14&type=section&id=Significant%20Events%20After%20Reporting%20Period) After the reporting period, the company completed a new share placement, raising approximately HKD 463 million for core product commercialization, clinical trials, and new product R&D, finalized H-share full circulation, entered a licensing deal with Excalipoint, and MRG004A received CDE Breakthrough Therapy Designation - On July 11, 2025, the company completed a placement of **93,825,000 shares**, raising net proceeds of approximately **HKD 462.94 million**[38](index=38&type=chunk) - Proceeds from the placement will be used for MRG003 commercialization (**20%**), core product clinical trials (**60%**), and new product R&D (**20%**)[38](index=38&type=chunk) - On July 21, 2025, **54,268,364 unlisted shares** of the company were converted into H-shares and listed[39](index=39&type=chunk) - On August 1, 2025, a licensing deal was reached with Excalipoint, granting global rights for two preclinical assets developed from the TOPAbody T-cell engager platform, receiving a **USD 10 million** upfront payment and up to **USD 847.5 million** in milestone payments[40](index=40&type=chunk)[42](index=42&type=chunk) - In August 2025, MRG004A was granted Breakthrough Therapy Designation (BTD) by the CDE for pancreatic cancer treatment[43](index=43&type=chunk) [Future Developments](index=15&type=section&id=Future%20Developments) The company will continue to focus on oncology, enriching its product portfolio through R&D and strategic partnerships, accelerating late-stage product commercialization, enhancing Puyouheng® accessibility and preparing MRG003 launch in the domestic market, and expanding internationally to seek more strategic partners - In drug R&D, the focus will be on strategic development of next-generation ADC drugs and immuno-oncology bispecific/trispecific antibodies, accelerating late-stage product commercialization[44](index=44&type=chunk) - For domestic commercialization, the company will enhance Puyouheng® market accessibility, expand market share, and prepare for MRG003's commercial launch[45](index=45&type=chunk) - Internationally, the company will expand its global network, explore new business development opportunities, and seek more strategic partners to develop ADC products and other innovative candidate drugs[46](index=46&type=chunk) [Financial Review](index=16&type=section&id=Financial%20Review) For the six months ended June 30, 2025, the company's revenue significantly grew 3.5 times to RMB 465.9 million, driven by MRG007 out-licensing income and Puyouheng® sales, with operating activities turning profitable, achieving a profit of RMB 29.3 million Revenue Composition and Year-on-Year Change | Revenue Source | H1 2025 (RMB Million) | H1 2024 (RMB Million) | Y-o-Y Change (%) | | :--- | :--- | :--- | :--- | | Total Revenue | 465.9 | 133.3 | 249.5% | | Out-licensing Revenue (primarily from MRG007) | 309.0 | 20.7 | 1392.7% | | Puyouheng® Sales Revenue | 150.6 | 94.8 | 58.8% | | CDMO Service Revenue | 6.3 | 17.8 | -64.6% | - Sales and marketing expenses increased to **RMB 97.9 million**, consistent with revenue growth[49](index=49&type=chunk) - Administrative expenses increased to **RMB 55.4 million**, primarily due to increased depreciation and property tax after the completion and operation of Shanghai Biotech Park, and higher professional fees[50](index=50&type=chunk) - R&D expenses were **RMB 202.2 million**, a decrease from **RMB 216.6 million** in the prior year period, mainly due to reduced clinical research-related expenses and adjustments in employee benefits expenses[52](index=52&type=chunk)[54](index=54&type=chunk) - Profit for the period was **RMB 29.3 million**, a turnaround from a loss of **RMB 197.0 million** in the same period of 2024[59](index=59&type=chunk) [Liquidity and Financial Resources](index=19&type=section&id=Liquidity%20and%20Financial%20Resources) As of June 30, 2025, the company reported a net cash inflow from operating activities of RMB 46.7 million, with cash and cash equivalents increasing to RMB 472.7 million, maintaining a stable gearing ratio and total bank borrowings of RMB 877.1 million - Net cash inflow from operating activities was **RMB 46.7 million**, a significant improvement from a net outflow of **RMB 115.1 million** in the same period of 2024[62](index=62&type=chunk) - Cash and cash equivalents increased to **RMB 472.7 million**, an increase of **RMB 71.4 million** from the end of 2024[62](index=62&type=chunk) - Total bank borrowings were **RMB 877.1 million**, of which **RMB 566.6 million** is repayable within one year[62](index=62&type=chunk) - The gearing ratio was **69.9%**, largely consistent with **70.1%** at the end of 2024[64](index=64&type=chunk) [Other Financial Information](index=19&type=section&id=Other%20Financial%20Information) During the reporting period, the company had no significant investments, acquisitions, or disposals, with capital commitments primarily for property, plant, and equipment, no contingent liabilities, no foreign exchange hedging policy, and an expanded employee team resulting in increased total staff costs - As of June 30, 2025, capital commitments were **RMB 448.7 million**, primarily for property, plant, and equipment[66](index=66&type=chunk) - As of June 30, 2025, the company had no contingent liabilities[67](index=67&type=chunk) - As of June 30, 2025, the Group had **546 employees**, with total staff costs of **RMB 110.3 million**, mainly due to the expansion of the sales team[70](index=70&type=chunk) [Use of Proceeds](index=20&type=section&id=Use%20of%20Proceeds) The company detailed the planned and actual use of proceeds from its listing and 2024 placement, with listing proceeds primarily for core product R&D and commercialization, and 2024 placement proceeds mainly for ADC candidate R&D and CG0070 clinical trials Use of Net Proceeds from Listing (as of June 30, 2025) | Proposed Use | Percentage of Total Net Proceeds | Net Allocation (RMB Million) | Amount Utilized as of June 30, 2025 (RMB Million) | Amount Utilized During Reporting Period (RMB Million) | Unutilized Amount as of June 30, 2025 (RMB Million) | | :--- | :--- | :--- | :--- | :--- | :--- | | Funding for core products | 68.51% | 450.57 | 439.50 | 26.43 | 11.07 | | Funding for other key clinical-stage and preclinical candidates | 6.35% | 41.70 | 40.35 | 1.10 | 1.35 | | Acquisition of potential technologies and assets and expansion of candidate pipeline | 15.79% | 103.85 | 103.85 | – | – | | General corporate purposes | 9.35% | 61.49 | 61.49 | – | – | | **Total** | **100%** | **657.61** | **645.19** | **27.53** | **12.42** | - The unutilized net proceeds from the listing are expected to be utilized by December 31, 2025[74](index=74&type=chunk) Use of Proceeds from 2024 Placement (as of June 30, 2025) | Intended Use | Percentage of Total Net Proceeds | Net Allocation (RMB Million) | Amount Utilized as of June 30, 2025 (RMB Million) | Amount Utilized During Reporting Period (RMB Million) | Unutilized Amount as of June 30, 2025 (RMB Million) | | :--- | :--- | :--- | :--- | :--- | :--- | | For R&D, clinical trials, registration, and other workflows for ADC candidate products | 70.00% | 146.43 | 84.43 | 59.85 | 62.00 | | For CG0070 clinical trials and other workflows | 20.00% | 41.84 | 0.14 | 0.14 | 41.70 | | For supplementing working capital and general corporate purposes | 10.00% | 20.92 | 19.87 | 0 | 1.05 | | **Total** | **100%** | **209.18** | **104.44** | **59.99** | **104.75** | - The unutilized net proceeds from the 2024 placement are expected to be utilized by December 31, 2026[76](index=76&type=chunk) [Other Information](index=23&type=section&id=Other%20Information) This section covers interests of directors and major shareholders, corporate governance, compliance, and the review of interim financial information and dividend policy [Interests of Directors, Supervisors, and Chief Executive](index=24&type=section&id=Interests%20of%20Directors%2C%20Supervisors%2C%20and%20Chief%20Executive) As of June 30, 2025, Dr. Pu Zhongjie and Ms. Pu Jue held interests in the company's H-shares primarily through controlled corporations, with no directors, supervisors, or chief executives holding disclosable interests or short positions in associated corporations' shares or debentures during the period Directors' Long Positions in the Company's Shares (as of June 30, 2025) | Director Name | Share Class | Nature of Interest | Number of Shares | Approximate Percentage of Relevant Share Class | Approximate Percentage of Shareholding | | :--- | :--- | :--- | :--- | :--- | :--- | | Dr. Pu Zhongjie | H-shares | Interest in controlled corporation | 658,591,549 | 39.76% | 38.50% | | Ms. Pu Jue | H-shares | Interest in controlled corporation | 90,000,000 | 5.43% | 5.26% | [Major Shareholders' Interests](index=25&type=section&id=Major%20Shareholders%27%20Interests) As of June 30, 2025, Hong Kong Miracogen, Miracogen Inc., Dr. Hu Zhaohong, and Suzhou Yipu No. 1 Equity Investment Partnership were major shareholders holding 5% or more interests, primarily through beneficial or controlled corporate interests Major Shareholders' Long Positions in the Company's Shares (as of June 30, 2025) | Shareholder Name | Share Class | Nature of Interest | Number of Shares | Approximate Percentage of Relevant Share Class | Approximate Percentage of Shareholding | | :--- | :--- | :--- | :--- | :--- | :--- | | Hong Kong Miracogen | H-shares | Beneficial interest | 131,496,106 | 7.94% | 7.69% | | Miracogen Inc. | H-shares | Interest in controlled corporation | 131,496,106 | 7.94% | 7.69% | | Dr. Hu Zhaohong | H-shares | Interest in controlled corporation | 131,496,106 | 7.94% | 7.69% | | Suzhou Yipu No. 1 Equity Investment Partnership | H-shares | Beneficial interest | 39,436,621 | 2.38% | 2.31% | | Suzhou Yipu No. 1 Equity Investment Partnership | Domestic shares | Beneficial interest | 39,436,620 | 72.67% | 2.31% | [Corporate Governance and Compliance](index=27&type=section&id=Corporate%20Governance%20and%20Compliance) During the reporting period, the company neither entered into arrangements for directors to acquire share or debenture interests nor purchased, sold, or redeemed any listed securities, while complying with corporate governance and securities dealing codes and disclosing changes in director and supervisor information - During the reporting period, neither the company nor its subsidiaries purchased, sold, or redeemed any listed securities[86](index=86&type=chunk) - The company has complied with the principles and code provisions set out in the Corporate Governance Code[90](index=90&type=chunk) - Non-executive Director Mr. Yang Hongbing resigned, and Ms. Qin Yiran was appointed as a non-executive director[91](index=91&type=chunk) [Interim Report Review and Dividends](index=29&type=section&id=Interim%20Report%20Review%20and%20Dividends) The interim financial information has been reviewed by independent auditor Ernst & Young, and the Audit Committee has reviewed financial reporting matters with management and the auditor, with the Board not recommending an interim dividend for the six months ended June 30, 2025 - This interim financial information has been reviewed by Ernst & Young in accordance with International Standard on Review Engagements 2410[94](index=94&type=chunk) - The Audit Committee has reviewed the interim results and deemed them compliant with applicable accounting standards, laws, and regulations[94](index=94&type=chunk) - The Board does not recommend the payment of an interim dividend for the six months ended June 30, 2025[95](index=95&type=chunk) [Review Report on Interim Financial Information](index=29&type=section&id=Review%20Report%20on%20Interim%20Financial%20Information) Independent auditor Ernst & Young has reviewed the company's interim financial information in accordance with International Standard on Review Engagements 2410, finding no matters that lead them to believe it is not prepared in all material respects in accordance with IAS 34 - The auditor has reviewed the interim financial information in accordance with International Standard on Review Engagements 2410[98](index=98&type=chunk) - The auditor concluded that nothing has come to their attention that causes them to believe the interim financial information is not prepared, in all material respects, in accordance with IAS 34[99](index=99&type=chunk) [Interim Condensed Consolidated Statement of Profit or Loss and Other Comprehensive Income](index=31&type=section&id=Interim%20Condensed%20Consolidated%20Statement%20of%20Profit%20or%20Loss%20and%20Other%20Comprehensive%20Income) For the six months ended June 30, 2025, the company achieved revenue of RMB 465,942 thousand, a significant increase year-on-year, with a profit for the period of RMB 29,302 thousand, reversing the prior year's loss, and basic earnings per share of RMB 0.02 Summary of Interim Condensed Consolidated Statement of Profit or Loss and Other Comprehensive Income | Metric | 2025 (RMB Thousand) | 2024 (RMB Thousand) | | :--- | :--- | :--- | | Revenue | 465,942 | 133,283 | | Gross Profit | 438,539 | 112,241 | | Operating Income / (Loss) | 42,981 | (184,036) | | Profit / (Loss) for the period | 29,302 | (196,966) | | Profit / (Loss) attributable to owners of the company | 41,745 | (192,430) | | Basic earnings / (loss) per share | 0.02 | (0.12) | [Interim Condensed Consolidated Statement of Financial Position](index=32&type=section&id=Interim%20Condensed%20Consolidated%20Statement%20of%20Financial%20Position) As of June 30, 2025, the company's total assets were RMB 2,361,606 thousand, with a significant portion in non-current assets, total equity at RMB 711,795 thousand, and total liabilities at RMB 1,649,811 thousand, with a higher proportion of current liabilities Summary of Interim Condensed Consolidated Statement of Financial Position | Metric | June 30, 2025 (RMB Thousand) | December 31, 2024 (RMB Thousand) | | :--- | :--- | :--- | | Total Assets | 2,361,606 | 2,280,685 | | Total Non-current Assets | 1,657,153 | 1,635,177 | | Total Current Assets | 704,453 | 645,508 | | Total Equity | 711,795 | 681,803 | | Total Liabilities | 1,649,811 | 1,598,882 | | Total Non-current Liabilities | 538,015 | 555,369 | | Total Current Liabilities | 1,111,796 | 1,043,513 | [Interim Condensed Consolidated Statement of Changes in Equity](index=34&type=section&id=Interim%20Condensed%20Consolidated%20Statement%20of%20Changes%20in%20Equity) For the six months ended June 30, 2025, equity attributable to owners increased from RMB 702,825 thousand at the beginning of the period to RMB 745,260 thousand, primarily due to profit for the period Summary of Interim Condensed Consolidated Statement of Changes in Equity | Metric | June 30, 2025 (RMB Thousand) | June 30, 2024 (RMB Thousand) | | :--- | :--- | :--- | | Total equity at beginning of period | 681,803 | 888,700 | | Profit / (Loss) for the period | 29,302 | (196,966) | | Other comprehensive income | 98 | 85 | | Total equity at end of period | 711,795 | 902,010 | [Interim Condensed Consolidated Statement of Cash Flows](index=35&type=section&id=Interim%20Condensed%20Consolidated%20Statement%20of%20Cash%20Flows) For the six months ended June 30, 2025, net cash flow from operating activities turned to an inflow of RMB 46,696 thousand from a prior year outflow, with net cash outflow from investing activities of RMB 43,166 thousand, net cash inflow from financing activities of RMB 63,353 thousand, and cash and cash equivalents at period-end of RMB 472,708 thousand Summary of Interim Condensed Consolidated Statement of Cash Flows | Metric | 2025 (RMB Thousand) | 2024 (RMB Thousand) | | :--- | :--- | :--- | | Net cash from / (used in) operating activities | 46,696 | (115,130) | | Net cash used in investing activities | (43,166) | (23,619) | | Net cash from financing activities | 63,353 | 225,985 | | Net increase in cash and cash equivalents | 66,883 | 87,236 | | Cash and cash equivalents at end of period | 472,708 | 513,640 | [Notes to the Interim Condensed Consolidated Financial Information](index=36&type=section&id=Notes%20to%20the%20Interim%20Condensed%20Consolidated%20Financial%20Information) This section provides detailed notes on the company's interim financial information, covering general data, accounting policies, financial risk management, segment reporting, and specific balance sheet and income statement items [General Information and Basis of Preparation](index=36&type=section&id=General%20Information%20and%20Basis%20of%20Preparation) The company, incorporated in Shanghai, China on January 19, 2018, focuses on global cancer targeted and immunotherapy discovery, development, and commercialization, with this interim condensed consolidated financial information prepared in accordance with IAS 34 on a going concern basis - The company primarily focuses on the discovery, development, and commercialization of global cancer targeted and immunotherapies[109](index=109&type=chunk) - This interim condensed consolidated financial information is prepared in accordance with International Accounting Standard 34 and presented on a going concern basis[111](index=111&type=chunk) [Accounting Policies and Financial Risk Management](index=37&type=section&id=Accounting%20Policies%20and%20Financial%20Risk%20Management) This period's financial information first adopted the revised IAS 21 with no significant impact on the Group, whose business is exposed to market, credit, and liquidity risks, with financial assets and liabilities measured at fair value - The amendments to International Accounting Standard 21 had no impact on the Group's interim condensed consolidated financial information[114](index=114&type=chunk) - The company's business is exposed to market risk, credit risk, and liquidity risk, with no significant changes in risk management policies since December 31, 2024[116](index=116&type=chunk)[117](index=117&type=chunk) Assets and Liabilities Measured at Fair Value (as of June 30, 2025) | Metric | Level 3 (RMB Thousand) | Total (RMB Thousand) | | :--- | :--- | :--- | | Financial assets at fair value through profit or loss | 63,628 | 63,628 | | Financial liabilities at fair value through profit or loss | 280,069 | 280,069 | [Segment Information and Revenue Composition](index=38&type=section&id=Segment%20Information%20and%20Revenue%20Composition) The company primarily engages in pharmaceutical product sales and new drug R&D, managed as a single operating segment, with revenue for the six months ended June 30, 2025, mainly from licensing income and pharmaceutical product sales, and a significant increase in overseas revenue contribution - The company's primary operating entities are located in mainland China, and management views the business as a single operating segment[122](index=122&type=chunk) Revenue Composition (for the six months ended June 30, 2025) | Revenue Type | 2025 (RMB Thousand) | 2024 (RMB Thousand) | | :--- | :--- | :--- | | Sales of pharmaceutical products | 150,645 | 94,836 | | Licensing income | 309,039 | 20,678 | | CDMO services | 6,258 | 17,769 | | **Total** | **465,942** | **133,283** | Revenue by Geographical Market (for the six months ended June 30, 2025) | Geographical Market | 2025 (RMB Thousand) | 2024 (RMB Thousand) | | :--- | :--- | :--- | | Mainland China | 156,903 | 112,605 | | Overseas | 309,039 | 20,678 | | **Total** | **465,942** | **133,283** | - Licensing income from ArriVent BioPharma INC. was approximately **RMB 295,033 thousand**, accounting for **63.32%** of total revenue[126](index=126&type=chunk) [Details of Statement of Profit or Loss Items](index=40&type=section&id=Details%20of%20Statement%20of%20Profit%20or%20Loss%20Items) This section details other income, profit before tax composition, net other losses, finance income and costs, income tax expense, and the calculation methods and specific data for earnings/loss per share Other Income (for the six months ended June 30, 2025) | Income Source | 2025 (RMB Thousand) | 2024 (RMB Thousand) | | :--- | :--- | :--- | | Government grants | 1,032 | 202 | | Individual income tax refunds | 225 | 316 | | Investment income from financial assets | 55 | – | | Others | 652 | 133 | | **Total** | **1,964** | **651** | - R&D expenses were **RMB 202,243 thousand**, with clinical research-related expenses accounting for **39.0%**[129](index=129&type=chunk)[54](index=54&type=chunk) - Finance income primarily derived from bank interest income and exchange gains, while finance costs mainly comprised interest on bank borrowings[132](index=132&type=chunk) - Income tax expense for the reporting period was **zero** due to no estimated taxable profit[133](index=133&type=chunk) - Basic earnings per share were **RMB 0.02**, compared to a loss of **RMB 0.12** in the same period last year[136](index=136&type=chunk) [Details of Statement of Financial Position Items](index=43&type=section&id=Details%20of%20Statement%20of%20Financial%20Position%20Items) This section details the carrying values and changes for property, plant and equipment, right-of-use assets, intangible assets, investments accounted for using the equity method, receivables, financial assets, share capital, borrowings, deferred income tax, and payables - The net book value of property, plant, and equipment was **RMB 941,514 thousand**, with a portion pledged as collateral for bank borrowings[140](index=140&type=chunk) - The net book value of intangible assets was **RMB 462,565 thousand**, with **RMB 39,097 thousand** of PD-1 product development costs capitalized during the period[143](index=143&type=chunk) - Trade receivables amounted to **RMB 49,749 thousand**, primarily due within **0 to 30 days**[149](index=149&type=chunk) - Total borrowings were **RMB 877,124 thousand**, comprising secured and unsecured bank borrowings[153](index=153&type=chunk) - The period-end balance of financial liabilities at fair value through profit or loss was **RMB 280,069 thousand**[160](index=160&type=chunk) [Commitments and Related Party Transactions](index=52&type=section&id=Commitments%20and%20Related%20Party%20Transactions) The company's capital commitments totaled RMB 448.7 million at the reporting period end, with this section detailing related party transactions including purchases, sales, leasing services, balances, and key management compensation, noting no dividends were paid or declared during the period - As of June 30, 2025, capital commitments were **RMB 448,663 thousand**, primarily for property, plant, and equipment[163](index=163&type=chunk) Transactions with Other Related Parties (for the six months ended June 30, 2025) | Transaction Type | 2025 (RMB Thousand) | 2024 (RMB Thousand) | | :--- | :--- | :--- | | Licensing income from associates | 13,992 | 20,678 | | CDMO service income from related parties | 6,258 | 17,769 | | Income from asset sales to related parties | 3,968 | – | | Purchase of professional services from related parties | 799 | 1,104 | | Purchase of raw materials from related parties | 265 | 16 | - Key management compensation totaled **RMB 3,140 thousand**, including salaries, bonuses, and retirement benefit costs[172](index=172&type=chunk) - Neither the company nor any Group companies paid or declared any dividends for the six months ended June 30, 2025, and 2024[173](index=173&type=chunk) [Events After Reporting Period](index=55&type=section&id=Events%20After%20Reporting%20Period) After the reporting period, the company completed a new H-share placement totaling approximately HKD 471 million, increasing total issued shares, and entered a licensing deal with Excalipoint for global rights to two preclinical assets from its T-cell engager platform, receiving a USD 10 million upfront payment and potential milestone payments - On July 11, 2025, the company completed a placement of **93,825,000 new H-shares**, raising total proceeds of approximately **HKD 471,002 thousand**[174](index=174&type=chunk) - On August 1, 2025, a licensing deal was reached with Excalipoint, granting global rights for two preclinical assets developed from the TOPAbody T-cell engager platform, receiving a **USD 10 million** cash upfront payment and **10% equity** in Excalipoint Cayman, plus up to **USD 847.5 million** in milestone payments[174](index=174&type=chunk) [Definitions and Technical Glossary](index=55&type=section&id=Definitions%20and%20Technical%20Glossary) This section provides detailed definitions for professional terms, abbreviations, and company-related entities used in the report, covering key vocabulary across pharmaceutical R&D, clinical trials, regulatory bodies, corporate governance, and finance, to enhance reader comprehension