Summary of Key Points Core Viewpoint - As of August 14, 200 stocks reached their 52-week highs, with notable performances from China Shun Ke Long (00974), Weijun Biotechnology (00660), and Century Group International (02113) leading the list with high rates of increase [1][2]. 52-Week High Rankings - China Shun Ke Long (00974) achieved a closing price of 1.380 and a peak price of 1.890, marking a 50.00% increase [2]. - Weijun Biotechnology (00660) closed at 0.239 with a peak of 0.280, reflecting a 40.70% increase [2]. - Century Group International (02113) had a closing price of 0.172 and a peak of 0.235, resulting in a 39.88% increase [2]. - Other notable stocks include: - China International (01064) with a 35.71% increase [2]. - Harmony Auto (03836) with a 22.91% increase [2]. - Guolian Communication (08060) with a 22.73% increase [2]. Additional Stocks with Significant Increases - Several other companies also showed notable increases, including: - Paig BioPharma-B (02565) with a 20.22% increase [2]. - Dinos Environmental (01452) with a 19.13% increase [2]. - Via Biotechnology (01873) with a 15.89% increase [2]. - The list continues with various companies achieving increases ranging from 10% to 15% [2][3]. 52-Week Low Rankings - The report also highlights stocks that reached their 52-week lows, such as: - Xi Ye Rong Technology (08107) with a decrease of 10.53% [6]. - Kun Group (00924) with a decrease of 9.84% [6]. - Lu Jin (01098) with a decrease of 9.21% [7].

Core Viewpoint - Yisheng Biotechnology (01061) experienced a stock price increase of over 10%, currently trading at 5.94 HKD with a transaction volume of 9.3261 million HKD, following the announcement of a joint development licensing agreement with Shanghai Junshi Biosciences Co., Ltd. [1] Group 1: Company Developments - Yisheng Biotechnology announced a joint development licensing agreement with its wholly-owned subsidiaries and Shanghai Junshi Biosciences, granting exclusive rights for the licensed product [1] - The licensed product is a recombinant anti-VEGF humanized monoclonal antibody, intended for the treatment of exudative (wet) age-related macular degeneration (wet AMD) [1] - The biological product license application for the anti-VEGF ophthalmic injection (HLX04-O) has recently been accepted by the National Medical Products Administration (NMPA) of China [1] Group 2: Product Details - HLX04-O is developed based on Junshi's independently developed Hanbeitai (Bevacizumab injection), optimized for ophthalmic use while maintaining the active ingredient [1] - The new ophthalmic formulation is designed to meet the specific needs for treating wet AMD [1]

亿胜生物科技(01061)涨超10%，截至发稿，涨9.39%，报5.94港元，成交额932.61万港元。 消息面上，亿胜生物科技发布公告，有关受许人(均为公司的全资附属公司)与上海复宏汉霖生物技术股 份有限公司(复宏汉霖)订立共同开发许可协议，以根据共同开发许可协议的条款共同开发许可产品及向 受许人授出有关许可产品的独家权利。许可产品为内含重组抗血管内皮生长因子人源化单克隆抗体 (anti-VEGF)作为原料药的生物药品，拟用于治疗渗出性(湿性)老年性黄斑部病变(湿性AMD)。 用以治疗湿性AMD的anti-VEGF眼用注射生物药品(HLX04-O)的生物制品许可申请已于近期获得中国国 家药品监督管理局(NMPA)药品审评中心(CDE)受理。 HLX04-O是在复宏汉霖自主研发的汉贝泰(贝伐珠单抗注射液)的基础上，根据眼科用药的需求对汉贝泰 (贝伐珠单抗注射液)的处方、规格和生产工艺进行优化，在活性成份不变的基础上，开发的新的眼科制 剂产品，拟用于湿性AMD的治疗。 ...

Core Viewpoint - Elysium Biotech (01061) shares rose over 10%, currently up 9.39% at HKD 5.94, with a trading volume of HKD 9.3261 million following the announcement of a joint development licensing agreement with Shanghai Junshi Biosciences Co., Ltd. [1] Group 1 - The joint development licensing agreement involves Elysium's wholly-owned subsidiaries and Junshi Biosciences for the co-development of licensed products [1] - The licensed product is a recombinant anti-VEGF humanized monoclonal antibody intended for the treatment of wet age-related macular degeneration (wet AMD) [1] - The biological product application for HLX04-O, an anti-VEGF ocular injection, has recently been accepted by the National Medical Products Administration (NMPA) of China [1] Group 2 - HLX04-O is developed based on Junshi's independently developed Hanbeitai (Bevacizumab injection), optimized for ophthalmic use while maintaining the active ingredient [1] - The new ophthalmic formulation is aimed at treating wet AMD, with adjustments made to the prescription, specifications, and production process [1]

Core Viewpoint - The announcement highlights a collaboration between the company and Shanghai Junshi Biosciences Co., Ltd. to jointly develop a biological drug for the treatment of wet age-related macular degeneration (wet AMD) [1] Group 1: Licensing Agreement - The company has entered into a joint development licensing agreement with Shanghai Junshi Biosciences, granting exclusive rights to the licensed product [1] - The licensed product is a recombinant anti-VEGF humanized monoclonal antibody intended for use as a raw material drug [1] Group 2: Product Development - The anti-VEGF eye injection biological drug (HLX04-O) has recently been accepted for review by the National Medical Products Administration (NMPA) in China [1] - HLX04-O is developed based on Junshi's independently developed Hanbeitai (Bevacizumab injection), optimized for ophthalmic use while maintaining the active ingredient [1] Group 3: Clinical Trials - A Phase III clinical trial (AURA-1) for HLX04-O in Chinese patients with wet AMD is set to reach its primary endpoint by April 2025 [2] - An international multicenter Phase III clinical trial (AURA-2) is ongoing in multiple European countries, Australia, the United States, and China, with the last patient visit scheduled for January 2025 [2]

Core Viewpoint - The announcement highlights a collaboration between the company and Shanghai Junshi Biosciences Co., Ltd. to jointly develop a biopharmaceutical product for the treatment of wet age-related macular degeneration (wet AMD) [1] Group 1: Licensing Agreement - The company has entered into a joint development licensing agreement with Shanghai Junshi Biosciences, granting exclusive rights to develop and market a product containing a recombinant anti-VEGF monoclonal antibody [1] - The licensed product is intended for use as a biopharmaceutical for treating wet AMD [1] Group 2: Product Development - The anti-VEGF eye injection biopharmaceutical (HLX04-O) has recently been accepted for review by the National Medical Products Administration (NMPA) in China [1] - HLX04-O is developed based on Junshi's independently researched and developed Hanbeitai (Bevacizumab injection), optimized for ophthalmic use while maintaining the active ingredient [1] Group 3: Clinical Trials - In addition to the Phase III clinical study (AURA-1) for HLX04-O in wet AMD patients in China, an international multicenter Phase III clinical study (AURA-2) is being conducted across multiple European countries, Australia, the United States, and China [2] - The final patient visit for the AURA-2 study is expected to be completed by January 2025 [2]

Group 1 - The core point of the article is that Edding Biotechnology (01061.HK) has received acceptance for its biopharmaceutical license application for the anti-VEGF eye injection product HLX04-O, intended for the treatment of wet AMD, from the National Medical Products Administration (NMPA) in China [1] - HLX04-O is developed based on the independently researched Hanbeitai (Bevacizumab injection) by the company, optimized for ophthalmic use in terms of formulation, specifications, and production processes while maintaining the same active ingredient [1] - As of the announcement date, there are no approved Bevacizumab products for the treatment of wet AMD in China, with projected sales for drugs targeting wet AMD in China estimated at approximately RMB 4.9 billion for 2024 according to the latest data from IQVIA CHPA [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佈之內容概不負責，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佈全部或任何部分內容而產生或因 倚賴該等內容而引致之任何損失承擔任何責任。 茲提述(i)億勝生物科技有限公司（「本公司」）日期為二零二零年十月十五日之公佈（「該公 佈」），內容有關受許人（均為本公司之全資附屬公司）與上海復宏漢霖生物技術股份有限公司 （「復宏漢霖」）訂立共同開發許可協議，以根據共同開發許可協議之條款共同開發許可產品及 向受許人授出有關許可產品之獨家權利；及(ii)本公司於二零二一年一月至二零二五年四月期 間刊發之若干公佈，內容有關上述事項的若干最新情況。許可產品為內含重組抗血管內皮生 長因子人源化單克隆抗體（「anti-VEGF」）作為原料藥之生物藥品，擬用於治療滲出性（濕性） 老年性黃斑部病變（「濕性AMD」）。除另有指明者外，本公佈所用詞彙與該公佈所界定者具有 相同涵義。 有關開發HLX04-O之進一步最新情況 （於開曼群島註冊成立之有限公司） （股份代號：1061） 有關滲出性（濕性）老年性黃斑部病變之治療 許可產品 生物製品許可申請已受理 現時市況 截至本 ...

Core Viewpoint - The joint application for the market approval of HLX04-O, a recombinant anti-VEGF monoclonal antibody injection for treating wet age-related macular degeneration (wAMD), has been submitted by Fuhong Hanlin and Edding Bio, marking the second such application for a bevacizumab ophthalmic formulation in China [2][4]. Group 1: Product Development - HLX04-O is developed using genetic engineering technology and specifically binds to VEGF, blocking its interaction with receptors on endothelial cells, thereby inhibiting endothelial cell proliferation and reducing neovascularization [2]. - The drug has successfully met the primary endpoint in a Phase III clinical trial (NCT05003245) comparing its efficacy and safety against ranibizumab in wAMD patients, showing non-inferiority in terms of best-corrected visual acuity improvement [3]. - An international multi-center Phase III clinical study (NCT04740671) is also being conducted for HLX04-O, with participants recruited from China, Australia, the EU, and the US [3]. Group 2: Market Context - Currently, there are no approved bevacizumab formulations for treating ophthalmic diseases in China, making HLX04-O a significant addition to the market [4]. - The only other application for a bevacizumab ophthalmic formulation, TAB014, was submitted by Zhaoke Ophthalmology and Dongyao Pharmaceutical in June 2023 for the treatment of wAMD [4].

Core Viewpoint - The joint application for the market approval of HLX04-O, a recombinant anti-VEGF monoclonal antibody injection for the treatment of wet age-related macular degeneration (wAMD), has been submitted by Fuhong Hanlin and Edding Bio, marking the second such application for a bevacizumab ophthalmic formulation in China [1][2][3] Group 1: Product Development - HLX04-O is developed using genetic engineering technology and specifically binds to VEGF, inhibiting its interaction with receptors on endothelial cells, thereby reducing neovascularization associated with wAMD [1] - The drug has successfully met the primary endpoint in a Phase III clinical trial (NCT05003245) comparing its efficacy and safety against Ranibizumab in wAMD patients, showing non-inferiority in terms of best-corrected visual acuity improvement [2] - An international multi-center Phase III clinical study (NCT04740671) is also being conducted for HLX04-O, with participants recruited from China, Australia, the EU, and the US [2] Group 2: Market Context - Currently, there are no approved bevacizumab formulations for ophthalmic diseases in China, making HLX04-O the second reported application for such a drug after TAB014 [3]