CanSino Biologics Inc. 康希諾生物股份公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：6185） 自願公告 獲 得PIC/S GMP認 證 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。 本次通過PIC/S GMP認 證，標 誌 著 本 公 司 的 生 產 和 質 量 管 理 體 系 符 合PIC/S GMP 的標準，將有助於推進MCV4、PCV13 i 在馬來西亞及其他PIC/S成員國藥品註冊上 市的工作。 本公司股東及潛在投資者在買賣本公司股份時務請審慎行事。 承董事會命 康希諾生物股份公司 Xuefeng YU 董事長 香港，2026年3月5日 於本公告日期，本公司董事會包括執行董事Xuefeng YU博士、Shou Bai CHAO博 士 及王靖女士；非執行董事李志成先生；以及獨立非執行董事張耀樑先生、左敏先 生及紀雪峰女士。 本 公 告 由 康 希 諾 生 物 股 份 公 司（「本公司」）自 願 作 出。 ...

Core Viewpoint - The A-share market experienced fluctuations with the innovative drug sector under pressure, yet the Huatai-PineBridge Innovation Drug ETF (589120) saw a continuous inflow of funds, attracting over 28 million yuan in three days despite a slight decline of 0.25% [1][3]. Group 1: Market Performance - The Huatai-PineBridge Innovation Drug ETF (589120) showed mixed performance among its constituent stocks, with notable gains from Kangxinuo (up over 6%), Borui Pharmaceutical (up over 4%), and Yifang Bio (up over 3%), while Baijie Shenzhou and Baili Tianheng experienced declines [3][4]. - The ETF's top ten constituent stocks include Baijie Shenzhou-U with a decline of 2.18% and Ailis with a minimal decline of 0.02%, while Borui Pharmaceutical and Yifang Bio showed positive growth [4]. Group 2: Industry Developments - Kangxinuo reported a revenue of approximately 1.068 billion yuan for 2025, marking a year-on-year increase of 26.18%, and achieved profitability with a net profit of about 27.87 million yuan [5]. - A significant licensing agreement was established between Frontier Bio and GlaxoSmithKline (GSK), with an upfront payment of 40 million USD and a total deal value exceeding 1 billion USD for two early-stage siRNA products [5]. - The FDA's new review policy, which allows for a single key clinical trial plus confirmatory evidence for drug approval, is expected to significantly reduce development costs and timelines, benefiting the innovative drug sector [7][8]. Group 3: R&D and Financial Trends - By 2025, the funding levels for Chinese pharmaceutical companies are projected to increase significantly, with a total of 201.5 billion yuan expected from IPOs and other financing activities, reflecting a 145% year-on-year growth [9]. - The willingness of Chinese innovative drug companies to invest in R&D is on the rise, driven by new business models that enhance return rates and reduce risks [9][10]. - The innovative drug sector is transitioning from a phase of R&D investment to a phase of commercial returns, with over 70% of companies expected to achieve revenue growth by 2025 [10][11].

Core Viewpoint - The announcement from CanSino indicates an expansion of the age range for its ACYW135 meningococcal polysaccharide conjugate vaccine, which is expected to positively impact the company's performance [1] Group 1 - The age range for the vaccine has been expanded from "3 months to 3 years (47 months)" to "3 months to 6 years (83 months)" [1] - The vaccine is identified as a quadrivalent meningococcal conjugate vaccine product in China [1] - The expansion of the applicable age group is anticipated to have a positive effect on the company's financial results [1]

Regulatory Updates - The National Medical Products Administration (NMPA) has released the "Guidelines for Pharmaceutical Research on Chemical Drugs for Rare Diseases (Trial)" to enhance support for rare disease drug development and improve technical guidance principles [1] - Hengrui Medicine's innovative drug SHR-1918 injection has been accepted for priority review by the NMPA, aimed at treating patients with homozygous familial hypercholesterolemia [1] - CanSino Biologics has expanded the age range for its ACYW135 meningococcal polysaccharide conjugate vaccine from children aged 3 months to 3 years to those aged 3 months to 6 years, which is expected to positively impact the company's performance [2] - Tongrentang Pharmaceutical has received product registration approval from Health Canada for several products, including children's cough syrup, although further administrative approvals are required for sales [3] - Shanghai Pharmaceuticals has obtained a drug registration certificate in Singapore for rivaroxaban tablets, which are used to reduce the risk of stroke and systemic embolism in non-valvular atrial fibrillation patients [4] - Baotai has received acceptance for the marketing authorization application of its drug BAT4406F, intended for treating adult patients with AQP4 antibody-positive neuromyelitis optica spectrum disorder [5] Industry Developments - Zhejiang Medicine plans to invest 250 million yuan in a silver economy fund in collaboration with a private equity fund, focusing on the healthcare sector [6] - Zhijiang Biology has completed a strategic increase in its stake in Sanyou Biopharmaceuticals, enhancing its position in the precision medicine sector [7] - Xianweida Biopharmaceutical has entered a commercialization agreement with Pfizer China for its GLP-1 receptor agonist, which could yield up to $495 million in payments [8] Financial Performance - Sangfor Technologies reported a projected net profit increase of 317.09% for 2025, driven by a significant collaboration with Pfizer that resulted in a revenue recognition of approximately 2.89 billion yuan [9] Capital Market Activities - Duorui Pharmaceuticals announced a stock suspension following the expiration of a tender offer period, pending confirmation of the offer results [10] - Jiutian Pharmaceutical completed a share buyback of 1.24% of its total shares, with a total transaction amount of 100 million yuan [11] - Shenlian Biopharmaceutical plans to acquire controlling interest in Shiziyuan Biotechnology for 237 million yuan, aiming to expand into innovative drug business [12]

Group 1 - The company received approval from the National Medical Products Administration to expand the age range for its ACYW135 meningococcal polysaccharide conjugate vaccine (CRM197 carrier) from "3 months to 3 years (47 months) children" to "3 months to 6 years (83 months) children" [1] - The product, branded as "Mankai Xin," is the first quadrivalent meningococcal conjugate vaccine approved in China, which was launched in December 2021, addressing the gap in high-end vaccines in the country and providing a better solution for preventing meningococcal disease in children under 6 years old [2] - The expansion of the age range for Mankai Xin is expected to positively impact the company's performance by facilitating further promotion and use of the vaccine, with the company committed to advancing production, batch release, and market sales [2]

Group 1 - The company received a supplementary application approval notice from the National Medical Products Administration for its ACYW135 meningococcal polysaccharide conjugate vaccine (CRM197 carrier), expanding the age range for its use from "3 months to 3 years (47 months) children" to "3 months to 6 years (83 months) children" [1][3] - The product, branded as "Mankai Xin," is the first quadrivalent meningococcal conjugate vaccine approved in China, which was launched in December 2021, addressing the gap in high-end vaccines in the country and providing a better solution for preventing meningococcal disease in children under 6 years old [2] - The expansion of the age range for the vaccine is expected to positively impact the company's performance and facilitate further promotion and use of the vaccine, with the company committed to advancing production, batch release, and market sales [3]

Core Viewpoint - The company received approval from the National Medical Products Administration for an expanded age range for its ACYW135 meningococcal polysaccharide conjugate vaccine (CRM197 carrier), now applicable for children aged 3 months to 6 years [1] Group 1 - The product, known as Manhaixin®, is the first quadrivalent meningococcal conjugate vaccine approved in China, which was launched in December 2021 [1] - The approval helps to narrow the gap between China and developed countries in the field of high-end vaccines, addressing the lack of such vaccines in the country [1] - Manhaixin® provides a superior solution for the prevention of meningococcal disease in children aged 6 years and below, demonstrating strong market performance and increasing market share [1]

Core Viewpoint - The company, CanSino (688185.SH), announced an expansion of the age range for its ACYW135 group meningococcal polysaccharide conjugate vaccine, which is expected to positively impact its performance [1] Group 1 - The product's age range has been expanded from "3 months to 3 years (47 months) children" to "3 months to 6 years (83 months) children" [1] - This vaccine is the first quadrivalent conjugate meningococcal vaccine product in China [1] - The expansion of the applicable age group is anticipated to have a positive effect on the company's performance [1]

Core Viewpoint - The company received approval from the National Medical Products Administration for an expanded age range for its ACYW135 meningococcal polysaccharide conjugate vaccine (CRM197 carrier), now applicable for children aged 3 months to 6 years [1] Group 1 - The product, known as Manhaixin®, is the first quadrivalent meningococcal conjugate vaccine approved in China, which was launched in December 2021 [1] - The approval helps to narrow the gap between China and developed countries in the field of high-end vaccines, addressing the lack of such vaccines in the country [1] - Manhaixin® provides a superior solution for the prevention of meningococcal disease in children aged 6 years and below, demonstrating strong market performance and increasing market share [1]