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份內容而產生或因倚賴該等內容而引致的 任 何 損 失 承 擔 任 何 責 任。 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. 四川科倫博泰生物醫藥股份有限公司 （於 中 華 人 民 共 和 國 註 冊 成 立 的 股 份 有 限 公 司） （股 份 代 號：6990） 須予披露交易 認購理財產品 與中國銀行的理財產品 2025年9月29日，本 公 司 訂 立 中 國 銀 行 結 構 性 存 款 協 議，據 此，本 公 司 同 意認購本金額為人民幣440百 萬 元 的 中 國 銀 行 結 構 性 存 款。 於 本 公 告 日 期，本 公 司 存 置 於 中 國 銀 行 的 理 財 產 品 的 未 償 還 本 金 額 為 人民幣440百 萬 元，即 中 國 銀 行 結 構 性 存 款 的 本 金 額。 《上 市 規 則》涵 義 由於於本公告日期存置於中國銀行的理財產 ...

Core Viewpoint - The announcement of a 100% tariff on all branded/patented drugs by Trump starting in October is expected to have limited impact on China's innovative drug industry chain, with no excessive concerns warranted [1] Group 1: Impact on Innovative Drugs - Most Chinese innovative drugs that are currently being exported have either established production capacity in the U.S. or have outsourced production to local CMO companies [1] - The majority of domestic innovative drugs are exported using a business development (BD) model, which mitigates the impact of the tariff [1] Group 2: Impact on CXO Sector - The export products in the CXO sector primarily consist of raw materials and biological raw liquids, which are not affected by the new tariff; the proportion of finished dosage forms exported is low [1] - The investment timeline for multinational corporations (MNCs) to build factories in China will take time, leading to limited direct impact on CXO orders in the short term [1] - Long-term policy changes may influence the pace of factory construction by MNCs [1] Group 3: Upcoming Catalysts - The ESMO conference will take place in mid to late October, with a focus on companies like CanSino Biologics (09926), Kelun-Biotech (06990), and Rongchang Biologics (09995) that are expected to release significant data [1] - The results of medical insurance negotiations and the first version of the commercial insurance innovative drug directory are expected to be announced in October-November [1] Group 4: Mid to Long-term Recommendations - Recommended stocks in the innovative drug sector include 3SBio (01530) and Eucure Biopharma-B (06996), which have rich short-term catalysts and their valuations do not yet reflect the core value of major products [2] - Companies like Ascletis Pharma (02096), Hutchison China MediTech (00013), and Legend Biotech are considered undervalued with clear long-term growth logic [2] - In the CXO sector, WuXi AppTec (02268) is highlighted as a leading player benefiting from high downstream demand and improving financing conditions [2]

Group 1 - The core viewpoint is that the new 100% tariff on all branded/patented drugs announced by Trump will have limited impact on China's innovative drug industry chain, and there is no need for excessive concern [1] - For innovative drugs, most products currently being exported are either produced in the U.S. or outsourced to U.S. CMO, and most domestic innovative drugs are exported using the BD model [1] - For CXO, the main export products are raw materials and herbal extracts, which are not affected by the new tariff; the proportion of finished drug exports is low, and the investment timeline for MNC clients to build factories will take time, leading to limited short-term impact on CXO orders [1] Group 2 - Mid to long-term recommendations include innovative drugs such as 3SBio (01530) and Eucure Biopharma-B (06996), which have rich short-term catalysts and their valuations do not yet reflect the core value of major products [2] - Other recommended companies include Ascletis Pharma (02096), Hutchison China MediTech (00013), and Legend Biotech, which are considered significantly undervalued with clear long-term growth logic [2] - For CXO, companies like WuXi AppTec (02268) are expected to benefit from high downstream demand and improving financing conditions [2]

Industry Rating - The report maintains an "Outperform" rating for the pharmaceutical and biotechnology industry [1] Core Insights - The innovative drug sector is experiencing a positive trend with significant revenue growth and a reduction in losses, indicating a potential for sector-wide profitability [2][6] - The overall revenue for the innovative drug sector in H1 2025 reached 30.649 billion yuan, a year-on-year increase of 9.77%, while the net loss attributable to shareholders was 2.096 billion yuan, showing a substantial reduction in losses [6] - The sector's gross margin remains high at 84.43%, with a slight decrease compared to the previous year, but showing signs of recovery in Q2 2025 [3][6] Summary by Sections Innovative Drug Sector - The innovative drug sector's revenue for H1 2025 was 30.649 billion yuan, with a growth rate of 9.77% year-on-year. Q2 2025 revenue was 16.387 billion yuan, reflecting a 33.24% increase [5][6] - The sector's gross margin for H1 2025 was 84.43%, slightly down from the previous year, but Q2 2025 saw an increase to 84.73% [3][6] - The number of License-out transactions with upfront payments exceeding 10 million USD reached a new high, indicating that overseas rights have become a crucial funding source for Chinese companies [4][7] Financial Performance - The innovative drug sector's net loss for H1 2025 was 2.096 billion yuan, with a significant reduction in losses of 127.58% year-on-year. The adjusted net loss was 2.880 billion yuan, reflecting a 151.25% reduction in losses [5][6] - The sector's operating cash flow was positive at 210 million yuan, indicating improved financial health [5] Traditional Pharmaceutical Sector - The traditional pharmaceutical sector, comprising 136 listed companies, reported total revenue of 254.895 billion yuan in H1 2025, a decrease of 1.64% year-on-year. The net profit attributable to shareholders was 32.099 billion yuan, down 4.83% [26][32] - The gross margin for the traditional pharmaceutical sector was 51.05% in H1 2025, showing a slight increase compared to the previous year [27][32] - The sector is adapting to policy changes, with increased industry concentration and some leading companies achieving growth through transformation and international expansion [32]

Core Viewpoint - The Hang Seng Healthcare Index fell by 1.4% this week, underperforming the market, with internet medicine, CXO, and traditional Chinese medicine sectors showing better performance [1] Group 1: Market Trends - Since September, the proportion of domestic holdings through the Hong Kong Stock Connect has remained stable, while foreign holdings have slightly decreased since mid-year [1] - Both domestic and foreign investors continue to increase their positions in innovative pharmaceutical companies, indicating a consistent long-term strategy [1] Group 2: Investment Recommendations - The report suggests focusing on companies with significant data releases at the upcoming ESMO conference in mid to late October, specifically mentioning Kangfang Biotech (09926), Kelun-Biotech (06990), and Rongchang Biotech (09995) [1] - The importance of timing and stock selection has increased following a broad rise in the innovative drug sector, with recommendations to gradually build positions during market corrections [1] Group 3: Sector Focus - For the innovative drug sector, the report highlights companies such as 3SBio (01530) and Eucure Biopharma-B (06996) as having rich short-term catalysts and undervalued core products, while companies like Ascletis Pharma (02096), Hutchison China MediTech (00013), and Legend Biotech are noted as significantly undervalued with clear long-term growth logic [1] - In the CXO sector, the report points to leading companies benefiting from high downstream demand and marginal recovery in financing, specifically mentioning WuXi AppTec (02268) [1]

Core Viewpoint - The Hang Seng Healthcare Index declined by 1.4% this week, underperforming the market, with internet medicine, CXO, and traditional Chinese medicine sectors showing better performance [1] Group 1: Market Trends - Since September, the proportion of domestic holdings through the Hong Kong Stock Connect has remained stable, while foreign holdings have slightly decreased since mid-year [1] - Both domestic and foreign investors continue to increase their positions in innovative pharmaceutical companies, indicating a consistent long-term strategy [1] Group 2: Investment Opportunities - Domestic investors are focusing on rebound opportunities, while foreign investors are increasing positions in innovative drug targets with high long-term potential and current cost-effectiveness [1] - The innovative drug guarantee model is gradually taking shape, which is expected to alleviate challenges such as hospital access and reimbursement difficulties for companies [1] Group 3: Upcoming Events - The ESMO conference will be held in mid to late October, and the report suggests focusing on companies like CanSino Biologics (09926), Kelun-Biotech (06990), and Rongchang Biologics (09995) that are expected to release significant data [1] Group 4: Stock Recommendations - The importance of timing and stock selection has increased after a broad rise in the innovative drug sector, with recommendations to gradually build positions during sector pullbacks [1] - Specific recommendations include: 1. Innovative drugs: 3SBio (01530), Eucure Biopharma-B (06996) with rich short-term catalysts and undervalued long-term growth logic [1] 2. CXO: Leaders in high-demand segments benefiting from improved financing conditions, such as WuXi AppTec (02268) [1]

Summary of Key Points from Conference Call Records Industry Overview - The conference call discusses the **Chinese innovative drug industry** and its current trends, particularly focusing on the **CRO (Contract Research Organization)** and **CDMO (Contract Development and Manufacturing Organization)** sectors [1][3][13]. Core Insights and Arguments - **Valuation Trends**: The valuation of Chinese innovative drugs is currently lower than historical peaks, with a static PS (Price to Sales) ratio around 7 times, compared to a high of 9.3 times. However, due to global competitiveness, the theoretical static PS is expected to exceed previous levels, driven by significant product cycles [2][4]. - **BD Activity**: There has been a surge in business development (BD) transactions among domestic innovative drug companies, with upfront payments in the first nine months of the year reaching **6.58 billion yuan**, surpassing the total of **6 billion yuan** for the entire previous year. The total transaction amount also exceeded **56.4 billion yuan** compared to **48.9 billion yuan** last year [4]. - **Immunotherapy and ADC Developments**: Chinese companies are showing strong global competitiveness in the dual-antibody sector, with significant clinical advancements. For instance, **AK12** from Kangfang Biotech has multiple ongoing Phase III trials, and **IBI363** from Innovent has received FDA approval for a global Phase III study in lung cancer [5][6]. - **Weight Loss Sector**: The weight loss sector is highlighted as a competitive area, with promising data from Eli Lilly's oral GLP-1 molecule, **ofgliprant**, providing opportunities for Chinese companies to improve their offerings [8][10]. Additional Important Insights - **CRO and CDMO Recovery**: The CRO industry has moved past its most challenging period, with increased investment activity and a recovery in overseas demand for Chinese CDMO companies. Key players such as WuXi AppTec and Tigermed are recommended for attention [3][13]. - **Upstream Pharmaceutical Chain Recovery**: There are signs of recovery in the upstream pharmaceutical supply chain, particularly in R&D, with companies like **BaiPuSiSi** experiencing a resurgence in market demand [14]. - **Global Competitiveness Strategies**: Chinese innovative drug companies are encouraged to enhance their global competitiveness through overseas sales, R&D, and potential licensing opportunities. Companies like BeiGene and Legend Biotech are highlighted for their performance in this regard [12]. Conclusion The conference call provides a comprehensive overview of the current state and future prospects of the Chinese innovative drug industry, emphasizing the importance of global competitiveness, active BD transactions, and the recovery of the CRO and CDMO sectors. The insights presented indicate a positive outlook for the industry, driven by innovation and strategic partnerships.

Core Viewpoint - The company, Kelun-Biotech (06990.HK), has announced that its new drug application (NDA) for the small molecule kinase inhibitor A400 (also known as EP0031) has been accepted by the National Medical Products Administration (NMPA) in China for the treatment of RET fusion-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) in adult patients [1] Group 1 - The acceptance of the NDA is based on positive results from the KL400-I/II-01 study, which included two key Phase 2 cohorts evaluating the efficacy and safety of A400/EP0031 administered orally at a dose of 90mg once daily (QD) for the treatment of RET fusion-positive locally advanced or metastatic NSCLC patients [1] - The two key clinical study cohorts achieved their primary efficacy endpoints, demonstrating good efficacy of A400/EP0031 in both previously treated and treatment-naive NSCLC patients, including those who had prior immunotherapy or brain metastases [1] - A400/EP0031 also showed encouraging and manageable tolerability and safety profiles [1]

Core Viewpoint - The company has received acceptance for a new drug application (NDA) for its RET small molecule kinase inhibitor project A400 (also known as EP0031) from the National Medical Products Administration (NMPA) in China, aimed at treating RET fusion-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) in adult patients [1] Group 1: Clinical Research and Development - The acceptance of the NDA is based on positive results from the KL400-I/II-01 study, which included two key Phase 2 cohorts evaluating the efficacy and safety of A400/EP0031 administered orally at a dose of 90mg once daily (QD) for both previously treated and treatment-naive RET fusion-positive locally advanced or metastatic NSCLC patients [1] - The primary efficacy endpoints of the two key clinical study cohorts have been met, demonstrating good efficacy of A400/EP0031 in both previously treated and treatment-naive NSCLC patients, including those who have previously undergone immunotherapy or have brain metastases [1] - A400/EP0031 has shown encouraging and manageable tolerability and safety profiles [1]

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 全部或任何部份內容而產生或因倚賴該等內容而引致的任何損失承擔任何責 任。 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. 四川科倫博泰生物醫藥股份有限公司 （於中華人民共和國註冊成立的股份有限公司） – 1 – （股份代號：6990） 自願公告 A400/EP0031新藥上市申請獲國家藥品監督管理局受理 四 川 科 倫 博 泰 生 物 醫 藥 股 份 有 限 公 司（「本公司」）董 事（「董 事」）董 事 會（「董 事 會」）欣 然 宣 佈，本 公 司 轉 染 過 程 中 重 排(RET)小分子激酶抑制劑項目A400（亦 稱 EP0031）的 一 項 新 藥 上 市 申 請(NDA)已獲中國國家藥品監督管理局(NMPA)藥 品 審評中心(CDE)受 理，用 於 治 療RET融合陽性局部晚期或轉移性非小細胞肺癌 (NSCLC)成 人 患 者。本 次 受 理 是 基 於KL ...