江蘇瑞科生物技術股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：2179） 內幕消息公告 中國證監會就本公司H股全流通計劃出具備案通知書 本公告乃由江蘇瑞科生物技術股份有限公司（「本公司」）根據香港法例第571章證 券及期貨條例第XIVA部（「內幕消息條文」）及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13.09(2)(a)條而作出。 茲提述本公司日期為2025年5月21日的公告（「該公告」），內容有關（其中包括）本 公司擬參與本次H股全流通。除另有說明外，本公告所用詞彙與該公告所界定者 具有相同涵義。 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。 Jiangsu Recbio Technology Co., Ltd. 本公司欣然宣佈，本公司已於近期收到中國證監會就本次H股全流通向本公司出 具的日期為2026年1月13日的備案通知書（「備案通知書」）。根據備案通知書，本 公司已就28名股東所持有的合計 ...

Group 1 - The China Securities Regulatory Commission has issued a notice regarding Jiangsu Ruike Biotechnology Co., Ltd.'s application for the conversion of 141,953,489 shares from domestic unlisted to overseas listed shares for trading on the Hong Kong Stock Exchange [1][4][5] - The shareholders involved in this conversion include various investment partnerships and funds, with significant contributions from entities such as Taizhou Yuangong Technology Partnership and Springleaf Investments Pte. Ltd. [4][5] Group 2 - Ruike Biotechnology has recently had its new drug application for the recombinant herpes zoster vaccine REC610 accepted by the National Medical Products Administration, which utilizes the company's self-developed BFA01 adjuvant [3] - Currently, the only other recombinant herpes zoster vaccine available globally is GlaxoSmithKline's Shingrix, indicating a competitive landscape for Ruike's new product [3]

Group 1 - The China Securities Regulatory Commission has issued a notice regarding Jiangsu Ruike Biotechnology Co., Ltd.'s application for the conversion of 141,953,489 shares from domestic unlisted to overseas listed shares for trading on the Hong Kong Stock Exchange [1][4][5] - The shareholders involved in this conversion include various investment partnerships and funds, with significant holdings from entities such as Taizhou Yuangong Technology Partnership and Springleaf Investments Pte. Ltd. [4][5] Group 2 - Ruike Biotechnology has recently had its new drug application for the recombinant herpes zoster vaccine REC610 accepted by the National Medical Products Administration, which utilizes a novel adjuvant BFA01 developed by the company [3] - Currently, the only other recombinant herpes zoster vaccine available globally is GlaxoSmithKline's Shingrix [3]

FF301 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12月31日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 江蘇瑞科生物技術股份有限公司 呈交日期: 2026年1月5日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 其他類別 (請註明) | | | 於香港聯交所上市 (註1) | | 否 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | N/A | 說明 | 內資股 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 154,824,311 | RMB | | | 1 RMB | | 154,824,311 | | 增加 / 減少 (-) | | | 143,112,702 | | | | RMB | | 143,112,702 | | 本月底結存 | | | 297,937,013 | RMB | | ...

Core Insights - The domestic pharmaceutical industry faced unprecedented challenges in 2025 due to policy adjustments, capital withdrawal, and intense competition, leading to a brutal industry reshuffle [2] - The shift in industry dynamics emphasizes clinical value as the core focus, with capital returning to rationality and competition shifting towards hard power [2] Group 1: Company Failures - *ST Changyao faced multiple crises, including a failed restructuring and financial fraud, resulting in a net asset of -643 million yuan and facing dual delisting risks [3] - Simi Biological, an early player in the mRNA field, entered bankruptcy liquidation due to a broken funding chain after raising over 1.3 billion yuan from 2020 to 2023 [5] - Green Valley Pharmaceutical's core product, "Jiuyi Yi," faced production halts due to expired registration and financial difficulties, leading to operational paralysis [6] - *ST Longjin was delisted due to reliance on a single product, with sales dropping significantly after price reductions and failed diversification attempts [7] - Shanghai Jinzhongnuomei, once a rising star, faced bankruptcy liquidation due to funding issues and high R&D costs [8] - Lizhu Group exited the PD-1 market after incurring significant losses, highlighting the challenges of entering saturated markets [9] - Ruike Biological's founder lost control of the company despite nearing commercialization of a core product, reflecting the struggles of innovation-driven firms [10] - Betta Pharmaceuticals faced a trust crisis due to overdue milestone payments, exposing cash flow issues in the innovative drug sector [11] - Keyuan Pharmaceutical's 3.58 billion yuan acquisition plan fell through, missing a critical transformation opportunity amid market changes [13] - Jikai Gene's founder faced legal issues due to an inability to repay 227 million yuan in debt, illustrating the pressures of capital constraints on companies [14]

Summary of Key Points Core Viewpoint - As of December 30, a total of 59 stocks reached their 52-week highs, with notable performers including Manman (08186), Base Champion Group (08460), and Gaoao International (08042) leading the gains in high rates of 32.63%, 23.92%, and 21.43% respectively [1]. Group 1: 52-Week Highs - Manman (08186) closed at 1.260, achieving a high rate of 32.63% [1] - Base Champion Group (08460) reached a closing price of 2.160, with a high rate of 23.92% [1] - Gaoao International (08042) closed at 0.068, marking a high rate of 21.43% [1] - Other notable stocks include Junyu Foundation (01757) with a high rate of 12.01% and TEAMWAY INTL at 11.11% [1] Group 2: 52-Week Lows - Huasheng Bio-B (02396) recorded a low rate of -15.81% with a closing price of 17.910 [3] - Ruike Bio-B (02179) reached a low rate of -14.89% with a closing price of 4.180 [3] - XI Ernan Samsung (07347) had a low rate of -12.89% with a closing price of 1.146 [3] - Other significant declines include Ziranmei (00157) at -11.36% and Yingji Tea Group (08241) at -11.11% [3] Group 3: Additional Stock Movements - Valiant International-B (09887) saw a decrease of -7.22% with a closing price of 51.000 [4] - Honglong China Real Estate (06968) dropped by -7.14% to 0.069 [4] - Other stocks with notable declines include Haowen Holdings (08019) at -6.67% and Xiaoyu Yingtong (00139) at -6.25% [4] Group 4: Minor Stock Movements - Star Health Travel (03662) decreased by -1.18% with a closing price of 0.420 [5] - Helen's (09869) saw a decline of -1.11% to 0.900 [5] - Other minor declines include Tiehuo (01029) at -1.09% and Lixin International (00191) at -1.03% [5]

Core Viewpoint - The company announced that its new adjuvanted recombinant shingles vaccine REC610 has received formal acceptance for its new drug application from the National Medical Products Administration, with acceptance number CXSS2500145 [1] Group 1: Vaccine Development - REC610 is designed to address shingles, a common disease caused by latent viral infection, affecting approximately 6 million people annually in China, with a trend of younger patients [1] - The vaccine utilizes the company's self-developed BFA01 adjuvant, which enhances the production of high levels of VZV glycoprotein E (gE) specific CD4+ T cells and antibodies [1] - Clinical trials for REC610 received approval from the National Medical Products Administration in October 2023, with full enrollment for Phase III trials expected by December 2024 [1] Group 2: Clinical Research - Ongoing clinical research is proceeding according to the protocol, with previous exploratory studies in the Philippines and China yielding expected results, demonstrating good safety and immune response capabilities [1]

Core Viewpoint - The company has received formal acceptance from the National Medical Products Administration for the new drug application of its adjuvanted recombinant shingles vaccine REC610, indicating progress in its development and potential market entry [1]. Group 1: Vaccine Development - REC610's new drug application has been officially accepted with acceptance number CXSS2500145 [1]. - The vaccine targets shingles, a common disease caused by latent viral infection, which affects approximately 6 million people annually in China, with a trend of younger patients [1]. - REC610 utilizes the company's proprietary adjuvant BFA01, which enhances the immune response by promoting high levels of VZV glycoprotein E (gE) specific CD4+ T cells and antibodies [1]. Group 2: Clinical Trials - REC610 received approval for clinical trials in October 2023, with the completion of all participant enrollments for Phase III trials expected by December 2024 [2]. - The clinical study is designed as randomized, double-blind, and placebo-controlled, focusing on the vaccine's efficacy, safety, and immunogenicity in healthy participants aged 40 and above [2]. - Previous exploratory clinical studies in the Philippines and China, using Shingrix® as a positive control, showed that REC610 has good overall safety and induces strong gE-specific immune responses comparable to Shingrix® [2].

Core Viewpoint - The company has received formal acceptance from the National Medical Products Administration for the new drug application of its adjuvanted recombinant herpes zoster vaccine REC610, indicating progress in its development and potential market entry [1]. Group 1: Vaccine Development - REC610's new drug application has been officially accepted with acceptance number CXSS2500145 [1]. - The vaccine targets herpes zoster, a common disease affecting approximately 6 million people annually in China, with a trend of increasing incidence among younger populations [1]. - REC610 utilizes the company's self-developed BFA01 adjuvant, which enhances the immune response by promoting high levels of VZV glycoprotein E (gE) specific CD4+ T cells and antibodies [1]. Group 2: Clinical Trials - REC610 received approval for clinical trials in October 2023, with the completion of participant enrollment for Phase III trials expected by December 2024 [2]. - The clinical study is designed as a randomized, double-blind, placebo-controlled trial to evaluate the vaccine's efficacy, safety, and immunogenicity in healthy participants aged 40 and above [2]. - Previous exploratory clinical studies in the Philippines and China, using Shingrix as a positive control, showed that REC610 has good overall safety and induces strong gE-specific immune responses comparable to Shingrix [2].

Core Viewpoint - The company has received formal acceptance from the National Medical Products Administration for the new drug application of its adjuvanted recombinant shingles vaccine REC610, indicating progress in its development and potential market entry [1] Group 1: Vaccine Development - REC610's new drug application acceptance number is CXSS2500145, marking a significant milestone for the company [1] - The vaccine targets shingles, a common disease caused by latent viral infection, which affects approximately 6 million people annually in China, with a trend of younger patients being affected [1] - REC610 utilizes the company's self-developed BFA01 adjuvant, which enhances the immune response by promoting high levels of VZV glycoprotein E (gE) specific CD4+ T cells and antibodies [1] Group 2: Clinical Trials - REC610 received a clinical trial approval notice from the National Medical Products Administration in October 2023, with the notice number 2023LP02151 [2] - The Phase III clinical trial is set to complete enrollment of all participants by December 2024, and is currently following the clinical protocol for subsequent observational visits [2] - The clinical study is designed as a randomized, double-blind, placebo-controlled trial to evaluate the vaccine's efficacy, safety, and immunogenicity in healthy participants aged 40 and above [2]