Cansino Receives GMP Certificate for Convideciaž, COVID-19 Vaccine

Total Page：16

File Type：pdf, Size：1020Kb

Cansino Receives GMP Certificate for Convideciaž, COVID-19 Vaccine

CanSino receives GMP certificate for Convidecia™, COVID-19 vaccine 25 May 2021 | News | By BioSpectrum Bureau This certification signifies CanSinoBIO's readiness to enter more markets in Europe and globally CanSino Biologics Inc has announced that its recombinant novel coronavirus vaccine, (Adenovirus Type 5 Vector) (‘Ad5- nCoV’, trade name: Convidecia™), has been granted a good manufacturing practice (GMP) certificate by the Hungarian National Institute of Pharmacy and Nutrition (OGYÉI). The certification was issued on May 21, 2021 after a thorough inspection of CanSinoBIO's production of Convidecia™. The GMP certificate recognises that CanSinoBIO's manufacturing facilities and quality control system comply with the high production standards and guidelines required by the European Union (EU). The EU GMP certification is required to import COVID-19 vaccines into the European Union and is regarded as a recognition of leading industry standards by many authorities outside of the EU. This certification signifies CanSinoBIO's readiness to enter more markets in Europe and globally. CanSinoBIO opened a new vaccine production site in Tianjin, China, with the expectation to produce over 200 million doses of Convidecia™ per annum. It will continue to expand its manufacturing capacity by collaborating with other top-tier pharmaceutical companies in China, including Shanghai Pharmaceuticals Holding Co, Ltd, to better meet the growing global demand. In March 2021, CanSinoBIO started the phase I clinical trial of an inhaled version of Convidecia™ immediately after receiving the approval from the National Medical Products Administration of China, marking another milestone in bringing more acceptable, affordable, timely and mass immune protection to the global population and reducing the burden placed on healthcare systems and medial workers..

Copy Link

Recommended publications

COVID-19: China Medical Supply Chains and Broader Trade Issues
COVID-19: China Medical Supply Chains and Broader Trade Issues Updated December 23, 2020 Congressional Research Service https://crsreports.congress.gov R46304 SUMMARY R46304 COVID-19: China Medical Supply Chains and December 23, 2020 Broader Trade Issues Karen M. Sutter, The outbreak of Coronavirus Disease 2019 (COVID-19), first in China, and then Coordinator globally, including in the United States, has drawn attention to the ways in which the Specialist in Asian Trade U.S. economy depends on manufacturing and supply chains based in China. This report and Finance aims to assess current developments and identify immediate and longer range China trade issues for Congress. Andres B. Schwarzenberg Analyst in International An area of particular concern to Congress has been U.S. shortages in medical supplies— Trade and Finance including personal protective equipment (PPE) and pharmaceuticals—as the United States stepped up efforts to contain the COVID-19 pandemic with limited domestic Michael D. Sutherland stockpiles and insufficient U.S. industrial capacity. Because of China’s role as a global Analyst in International supplier of PPE, medical devices, antibiotics, and active pharmaceutical ingredients, Trade and Finance reduced exports from China led to shortages of critical medical supplies in the United States. Exacerbating the situation, in early February 2020, the Chinese government nationalized control of the production and distribution of medical supplies in China— directing all production for domestic use—and directed the bureaucracy and Chinese industry to secure supplies from the global market. Once past the initial peak of its COVID-19 outbreak, the Chinese government appears to have prioritized certain countries and selectively released some medical supplies for overseas delivery.
[Show full text]
Annual Report DBX ETF Trust
May 31, 2021 Annual Report DBX ETF Trust Xtrackers Harvest CSI 300 China A-Shares ETF (ASHR) Xtrackers Harvest CSI 500 China A-Shares Small Cap ETF (ASHS) Xtrackers MSCI All China Equity ETF (CN) Xtrackers MSCI China A Inclusion Equity ETF (ASHX) DBX ETF Trust Table of Contents Page Shareholder Letter ....................................................................... 1 Management’s Discussion of Fund Performance ............................................. 3 Performance Summary Xtrackers Harvest CSI 300 China A-Shares ETF ........................................... 6 Xtrackers Harvest CSI 500 China A-Shares Small Cap ETF .................................. 8 Xtrackers MSCI All China Equity ETF .................................................... 10 Xtrackers MSCI China A Inclusion Equity ETF ............................................ 12 Fees and Expenses ....................................................................... 14 Schedule of Investments Xtrackers Harvest CSI 300 China A-Shares ETF ........................................... 15 Xtrackers Harvest CSI 500 China A-Shares Small Cap ETF .................................. 20 Xtrackers MSCI All China Equity ETF .................................................... 28 Xtrackers MSCI China A Inclusion Equity ETF ............................................ 33 Statements of Assets and Liabilities ........................................................ 42 Statements of Operations ................................................................. 43 Statements of Changes in Net
[Show full text]
Annual Report Contents
T R L REPO Stock Code: 6185 Stock Code: A 2019 ANNU (A joint stock company incorporated in the People’s Republic of China with limited liability) in the People’s (A joint stock company incorporated 康希諾生物股份公司 CAnSIno BIoloGICS InC. AnnuAl RepoRt 2019 Contents Corporate Information 2 Financial Summary 4 Chairman’s Statement 5 Management Discussion and 6 Analysis Directors, Supervisors and Senior 19 Management Corporate Governance Report 27 Environmental, Social and 38 Governance Report Report of the Directors 64 Report of the Supervisors 77 Independent Auditor’s Report 79 Consolidated Statement of 84 Comprehensive Income Consolidated Balance Sheet 85 Consolidated Statement of Changes 86 in Equity Consolidated Statement of Cash 87 Flows Notes to the Consolidated Financial 88 Statements Definitions 142 Corporate Information BOARD OF DIRECTORS NOMINATION COMMITTEE Executive Directors Mr. Jianzhong LIU (Chairman) Dr. Xuefeng YU Dr. Xuefeng YU Mr. Shiu Kwan Danny WAI (Chairman, chief executive officer and general manager) Mr. Shuifa GUI Dr. Shou Bai CHAO Ms. Nisa Bernice Wing-Yu LEUNG (Chief operating officer and deputy general manager) Dr. Tao ZHU SUPERVISORS (Chief scientific officer and deputy general manager) Dr. Dongxu QIU Ms. Jiangfeng LI (Chairwoman) (Senior vice president and deputy general manager) Ms. Jieyu ZOU Ms. Zhengfang LIAO Non-executive Directors AUTHORISED REPRESENTATIVES Mr. Qiang XU Mr. Liang LIN Dr. Xuefeng YU Ms. Nisa Bernice Wing-Yu LEUNG Mr. Ming King CHIU Mr. Zhi XIAO JOINT COMPANY SECRETARIES Independent Non-executive Directors Mr. Jin CUI Mr. Shiu Kwan Danny WAI Mr. Ming King CHIU (FCIS FCS (PE)) Ms. Zhu XIN Mr. Shuifa GUI Mr.
[Show full text]
Global Offering
(A joint stock company incorporated in the People's Republic of China with limited liability) STOCK CODE : 6185 GLOBAL OFFERING Joint Sponsors, Joint Global Coordinators, Joint Bookrunners and Joint Lead Managers Joint Global Coordinators, Joint Bookrunners and Joint Lead Managers Joint Bookrunners and Joint Lead Managers IMPORTANT If you are in any doubt about any of the contents of this Prospectus, you should obtain independent professional advice. CanSino Biologics Inc. 康希諾生物股份公司 (a joint stock company incorporated in the People’s Republic of China with limited liability) GLOBAL OFFERING Number of Offer Shares in the : 57,248,600 H Shares (subject to the Global Offering Over-allotment Option) Number of Hong Kong Offer Shares : 5,725,200 H Shares (subject to adjustment) Number of International Offer Shares : 51,523,400 H Shares (subject to adjustment and the Over-allotment Option) Maximum Offer Price : HK$22.00 per H Share, plus brokerage of 1%, Stock Exchange trading fee of 0.005% and SFC transaction levy of 0.0027% (payable in full on application in Hong Kong Dollars and subject to refund) Nominal Value : RMB1.00 per H Share Stock Code : 6185 Joint Sponsors, Joint Global Coordinators, Joint Bookrunners and Joint Lead Managers Joint Global Coordinators, Joint Bookrunners and Joint Lead Managers Joint Bookrunners and Joint Lead Managers Hong Kong Exchanges and Clearing Limited, The Stock Exchange of Hong Kong Limited and Hong Kong Securities Clearing Company Limited take no responsibility for the contents of this Prospectus, make no representation as to its accuracy or completeness, and expressly disclaim any liability whatsoever for any loss howsoever arising from or in reliance upon the whole or any part of the contents of this Prospectus.
[Show full text]
Transparency in the Development and Procurement of Covid-19 Vaccines
FOR WHOSE BENEFIT? TRANSPARENCY IN THE DEVELOPMENT AND PROCUREMENT OF COVID-19 VACCINES This document summarises the findings from 20 COVID-19 vaccine candidates our For Whose Benefit? report, it provides included in analysis1 an overview of the key risks of a lack of Name of vaccine Name of vaccine transparency in COVID-19 vaccine clinical trials developer and procurement contracts, and suggests Moderna mRNA-1273 recommendations for reform. Pfizer/BioNTech Comirnaty (BNT162b2) Our findings carry important implications, not only for the Medicago CoVLP development of COVID-19 medical technology, but also (w/GSK adjuvant) for future health emergencies and the wider governance of Anhui Zhifei Longcom ZF2001 pharmaceutical development and public procurement. The elements highlighted in our analysis are important in bringing Bharat Biotech Covaxin (BBV152) COVID-19 vaccines to market whilst offering important CureVac CVnCoV opportunities to move the dial in wider conversations on transparency beyond the pandemic. Clover Biopharmaceuticals SCB-2019 (w/GSK adjuvant) Sinopharm (Beijing) BBIBP-CorV AZD1222 / Covishield Key Findings AstraZeneca (ChAdOx1 nCoV-19) The report reveals a disturbing trend of poor transparency CanSino Biologics Convidicea (Ad5-nCoV) in clinical trials as well as in contracting for the supply of vaccines. This is highlighted by: Johnson & Johnson Ad26.COV2.S • The incoherent global clinical trial transparency policy Novavax NVX-CoV2373 landscape. • Poor sharing of vaccine clinical trial protocols. Sinovac Biotech CoronaVac Gamaleya Research • The frequent use of media to announce clinical trial Sputnik V Institute results without the accompanying publication of the associated data analysis, facilitating misinformation and AnGes AG0302-COVID19 misunderstanding. Zydus Cadila ZyCoV-D • Extremely low publication of contracts worldwide.
[Show full text]
Annual Report 2018
Annual Report 2018 (a joint stock limited company incorporated in the People’s Republic of China with limited liability) ANNUAL REPORT 2018 Our Vision Dedicate to become a first-tier enterprise in the global mainstream pharmaceutical and healthcare market. Our Mission We continuously enhance the capabilities for innovation, service, integration and international operations to efficiently operate, manage and invest in outstanding enterprises in the industry so that we can become a leading provider of healthcare products and services. 02 Shanghai Fosun Pharmaceutical (Group) Co., Ltd. Contents 02 Corporate Information 05 Financial Highlights 06 Chairman’s Statement 12 Management Discussion and Analysis 51 Five-Year Statistics 52 Report of the Directors 70 Supervisory Committee Report 72 Corporate Governance Report 82 Biographical Details of Directors, Supervisors and Senior Management 90 Independent Auditor’s Report 96 Consolidated Statement of Profit or Loss 97 Consolidated Statement of Comprehensive Income 98 Consolidated Statement of Financial Position 100 Consolidated Statement of Changes in Equity 102 Consolidated Statement of Cash Flows 105 Notes to Financial Statements 241 Definitions Annual Report 2018 01 Corporate Information Directors Authorized Representatives Executive Directors Mr. Chen Qiyu (陳啟宇) Mr. Chen Qiyu (陳啟宇) (Chairman) Ms. Lo Yee Har Susan (盧綺霞) Mr. Yao Fang (姚方) (Co-Chairman) Mr. Wu Yifang (吳以芳) Strategic Committee (President and Chief Executive Officer) Mr. Chen Qiyu (陳啟宇) (Chairman) Mr. Yao Fang (姚方) Non-executive Directors Mr. Wu Yifang (吳以芳)5 Mr. Wang Qunbin (汪群斌) Mr. Wang Qunbin (汪群斌) Mr. Wang Can (王燦) Mr. Wai Shiu Kwan Danny (韋少琨) Ms. Mu Haining (沐海寧)1 Mr. Guo Guangchang (郭廣昌)2 Mr.
[Show full text]
Cansino Biologics Inc. 康希諾生物股份公司 (A Joint Stock Company Incorporated in the People’S Republic of China with Limited Liability) (Stock Code: 6185)
Hong Kong Exchanges and Clearing Limited and The Stock Exchange of Hong Kong Limited take no responsibility for the contents of this announcement, make no representation as to its accuracy or completeness and expressly disclaim any liability whatsoever for any loss howsoever arising from or in reliance upon the whole or any part of the contents of this announcement. CanSino Biologics Inc. 康希諾生物股份公司 (A joint stock company incorporated in the People’s Republic of China with limited liability) (Stock code: 6185) INSIDE INFORMATION RECOMBINANT COVID-19 VACCINE (ADENOVIRUS TYPE 5 VECTOR) GRANTED EMERGENCY USE AUTHORIZATION IN PAKISTAN This announcement is made by CanSino Biologics Inc. (the “Company”) pursuant to Rule 13.09 of the Rules Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited (the “Listing Rules”) and the Inside Information Provisions (as defined in the Listing Rules) under Part XIVA of the Securities and Futures Ordinance (Chapter 571, Laws of Hong Kong). The Company is pleased to announce that based on the interim results for phase III clinical trial of the Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) (the “Ad5-nCoV”), Ad5-nCoV has been granted emergency use authorization by the Drug Regulatory Authority of Pakistan. The trade name of Ad5-nCoV is Convidecia™. Shareholders and potential investors of the Company are advised to exercise caution when dealing in the shares of the Company. By Order of the Board CanSino Biologics Inc. Xuefeng YU Chairman Hong Kong, February 16, 2021 As at the date of this announcement, the board of directors comprises Dr. Xuefeng YU, Dr.
[Show full text]
China's Covid Vaccines Are Going Global
News in focus VCG VIA GETTY VCG Students are inoculated at a mass-vaccination hub at Peking University in Beijing. CHINA’S COVID VACCINES ARE GOING GLOBAL — BUT QUESTIONS REMAIN The WHO has approved one of China’s COVID-19 vaccines for use worldwide, and another is under review. But published trial data remain scarce. By Smriti Mallapaty Disease Research, Bangladesh, in Dhaka. before the Sinopharm vaccine was listed. He The first vaccine to be listed is made in Beijing said a positive response would be “good news he World Health Organization (WHO) by the Chinese state firm Sinopharm. The other for the vaccine developers and for the countries has authorized the first of China’s under review — named CoronaVac — is produced that are interested in getting these vaccines”. COVID-19 vaccines for emergency use, by the private company Sinovac Biotech, also The WHO approval process assesses safety, and another could be listed in the com- based in Beijing. Five COVID-19 vaccines have efficacy and manufacturing quality, says Qadri. ing days, potentially opening the door already been authorized by the WHO, but, unlike Approved products can be purchased by Tto widespread distribution in lower-income these, the Chinese ones use inactivated virus United Nations agencies. “Until that happens, it nations through the COVID-19 Vaccines Global and are not widely used in Western nations. will be up to the individual countries to procure Access (COVAX) initiative. Sinopharm and Sinovac’s vaccines account the vaccines, and most countries will be not be The listing will boost global confidence for the bulk of shots given in China, which has able to,” she adds.
[Show full text]
China: the World's Fastest-Growing Biologics Market
CRO/CDMO RIDING THE CHINESE BIOTECH BOOM China: The World's Fastest-Growing Biologics Market Government spurring innovation BIOLOGICS MARKET CAGR (2016-2021) In our November 2019 issue, we highlighted the market potential of the Chinese 18 biopharma sector. Thanks to government reforms and key drivers, Chinese biotech 16 companies are no longer imitators but innovators. 14 • The Chinese biotech market, the second-largest drug market in the world, is 12 expected to grow at a CAGR of 16% by 2021. 10 • The Chinese FDA (CFDA) has implemented several changes to modernize the 8 clinical trial process and speed up the approval of innovative drugs. 6 CDMO/CRO to support strong growth in China R&D spending 4 2 R&D spending in the healthcare sector has risen sharply, pushing companies to 0 increase outsourcing, for better cost control and higher efficiency. China US Europe Japan • There are two types of outsourcing services: Contract Research Organizations (CRO) and Contract Development & Manufacturing Organizations (CDMO). • China’s domestic drugmakers are keen on using these services to remain competitive and to launch innovative drugs as quickly as possible. PLENTY OF ROOM TO GROW FOR CHINESE BIOLOGICS Wuxi Biologics: our top pick 2021e Sales Biologics as % of total drug sales We believe that Wuxi Biologics is well positioned to benefit from the growth opportunities in China, thanks to its leading market share, high quality and well U.S. $260bn ~30% differentiated services. • Wuxi has a 75% market share in CRO services for biologics. China $43bn ~12% • The COVID-19 pandemic has delayed many clinical programs, but CROs helped to ensure consistent and continuous trials.
[Show full text]
Annual Report Contents
(A joint stock company incorporated in the People’s Republic of China with limited liability) Stock Code: 6185 2020 ANNUAL REPORT Contents Corporate Information 2 Financial Summary 4 Chairman’s Statement 5 Management Discussion and Analysis 6 Directors, Supervisors and Senior Management 20 Corporate Governance Report 27 Environmental, Social and Governance Report 40 Report of the Directors 66 Report of the Supervisors 80 Independent Auditor’s Report 82 Consolidated Statement of Comprehensive Income 87 Consolidated Balance Sheet 88 Consolidated Statement of Changes in Equity 89 Consolidated Statement of Cash Flows 90 Notes to the Consolidated Financial Statements 91 Definitions 144 Corporate Information BOARD OF DIRECTORS NOMINATION COMMITTEE Executive Directors Mr. Jianzhong LIU (Chairman) Dr. Xuefeng YU Dr. Xuefeng YU Mr. Shiu Kwan Danny WAI (Chairman, chief executive officer and general manager) Mr. Shuifa GUI Dr. Shou Bai CHAO Ms. Nisa Bernice Wing-Yu LEUNG (Chief operating officer and deputy general manager) Dr. Tao ZHU SUPERVISORS (Chief scientific officer and deputy general manager) Dr. Dongxu QIU Ms. Jiangfeng LI (Chairwoman) (Executive vice president and deputy general manager) Ms. Jieyu ZOU Ms. Zhengfang LIAO Non-executive Directors AUTHORISED REPRESENTATIVES Mr. Qiang XU Mr. Liang LIN Dr. Xuefeng YU Ms. Nisa Bernice Wing-Yu LEUNG Mr. Ming King CHIU Mr. Zhi XIAO JOINT COMPANY SECRETARIES Independent Non-executive Directors Mr. Jin CUI Mr. Shiu Kwan Danny WAI Mr. Ming King CHIU (FCG FCS (PE)) Ms. Zhu XIN Mr. Shuifa GUI HEADQUARTERS AND REGISTERED Mr. Jianzhong LIU OFFICE IN THE PRC AUDIT COMMITTEE 401-420, 4th Floor Biomedical Park Ms. Zhu XIN (Chairwoman) 185 South Avenue Mr.
[Show full text]
Cansinobio's Single-Dose COVID-19 Vaccine Gets Approval in Chile
CanSinoBIO's single-dose COVID-19 vaccine gets approval in Chile 09 April 2021 | News | By Hithaishi CB Marks vaccine's first approval in South America, following Mexico, Pakistan, China and Hungary China based CanSino Biologics Inc. has announced that the Instituto de Salud Pública de Chile ("ISP") granted emergency use authorization for its Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) ("Ad5-nCoV", trade name: Convidecia™). This marks the first approval of Convidecia™ in South America and the first single-dose COVID-19 vaccine approved for emergency use in Chile. On February 25, 2021, Convidecia™ was granted conditional marketing authorization by the National Medical Products Administration of China ("NMPA"), the first of its kind authorized in China. Globally, Convidecia™ received authorization for emergency use by the Hungarian National Institute of Pharmacy and Nutrition (OGYÉI) in March 2021, and by the Federal Commission for Protection against Sanitary Risks of Mexico and the Drug Regulatory Authority of Pakistan for adults aged 18 and above in February 2021. In addition, on March 22, 2021, the NMPA granted approval of CanSinoBIO's clinical trial application for an inhaled version of COVID-19 vaccine, marking an important step forward in the Company's global fight against the COVID-19 pandemic as the virus continues to evolve. The interim analysis data of phase III clinical trial of Convidecia™ shows that Convidecia™ has overall efficacy of 65.28% at preventing all symptomatic COVID-19 disease 28 days after single-dose vaccination, and 68.83% at preventing all symptomatic COVID-19 disease 14 days after single-dose vaccination.
[Show full text]
Vanguard Emerging Markets Stock Index Fund
Annual Report | October 31, 2020 Vanguard Emerging Markets Stock Index Fund See the inside front cover for important information about access to your fund’s annual and semiannual shareholder reports. Important information about access to shareholder reports Beginning on January 1, 2021, as permitted by regulations adopted by the Securities and Exchange Commission, paper copies of your fund’s annual and semiannual shareholder reports will no longer be sent to you by mail, unless you specifically request them. Instead, you will be notified by mail each time a report is posted on the website and will be provided with a link to access the report. If you have already elected to receive shareholder reports electronically, you will not be affected by this change and do not need to take any action. You may elect to receive shareholder reports and other communications from the fund electronically by contacting your financial intermediary (such as a broker-dealer or bank) or, if you invest directly with the fund, by calling Vanguard at one of the phone numbers on the back cover of this report or by logging on to vanguard.com. You may elect to receive paper copies of all future shareholder reports free of charge. If you invest through a financial intermediary, you can contact the intermediary to request that you continue to receive paper copies. If you invest directly with the fund, you can call Vanguard at one of the phone numbers on the back cover of this report or log on to vanguard.com. Your election to receive paper copies will apply to all the funds you hold through an intermediary or directly with Vanguard.
[Show full text]