Tianjin Shin Poong Pharmaceutical Co., Ltd.

序号受理号药品名称申请人批准文号批准日期1JYHZ2100562国米氮平片山德士（中国）制药有限公司国药准字HJ201811722022年07月29日2JYHZ2100563国米氮平片山德士（中国）制药有限公司国药准字HJ201811732022年07月29日3JYHZ2200055国苹果酸舒尼替尼胶囊辉瑞投资有限公司国药准字HJ20171137；国药准字HJ201711382022年07月29日4JYHZ2200056国苹果酸舒尼替尼胶囊辉瑞投资有限公司国药准字HJ20171139；国药准字HJ201711402022年07月29日5JYHZ2200057国苹果酸舒尼替尼胶囊辉瑞投资有限公司国药准字HJ20171143；国药准字HJ201711442022年07月29日6JYHZ2200058国苹果酸舒尼替尼胶囊辉瑞投资有限公司国药准字HJ20171141；国药准字HJ201711422022年07月29日7JYHZ2200059国注射用头孢替唑钠天津新丰制药有限公司国药准字HJ201711182022年07月29日8JYHZ2200060国注射用头孢替唑钠天津新丰制药有限公司国药准字HJ201711162022年07月29日9JYHZ2200061国注射用头孢替唑钠天津新丰制药有限公司国药准字HJ201711152022年07月29日10JYHZ2200062国注射用头孢替唑钠天津新丰制药有限公司国药准字HJ201711172022年07月29日11JYHZ2200063国注射用头孢西酮钠天津新丰制药有限公司国药准字HJ201711022022年07月29日12JYHZ2200064国注射用头孢西酮钠天津新丰制药有限公司国药准字HJ201711002022年07月29日13JYHZ2200065国注射用头孢西酮钠天津新丰制药有限公司国药准字HJ201710992022年07月29日14JYHZ2200066国注射用头孢西酮钠天津新丰制药有限公司国药准字HJ201711012022年07月29日15JYHZ2200067国甲巯咪唑片默克雪兰诺有限公司国药准字HJ201711542022年07月29日16JYHZ2200068国甲巯咪唑片默克雪兰诺有限公司国药准字HJ201711552022年07月29日17JYHZ2200069国甲巯咪唑片默克雪兰诺有限公司国药准字HJ201711562022年07月29日18JYHZ2200070国多索茶碱注射液杭州科源创信医药有限公司国药准字HJ201703232022年07月29日19JYHZ2200071国氢溴酸伏硫西汀片灵北（北京）医药信息咨询有限公司国药准字HJ20170381；国药准字HJ201703822022年07月29日20JYHZ2200072国氢溴酸伏硫西汀片灵北（北京）医药信息咨询有限公司国药准字HJ20170383；国药准字HJ201703842022年07月29日21JYHZ2200073国氢溴酸伏硫西汀片灵北（北京）医药信息咨询有限公司国药准字HJ202020012022年07月29日22JYHZ2200074国重酒石酸卡巴拉汀胶囊北京诺华制药有限公司国药准字HJ201810432022年07月29日23JYHZ2200075国重酒石酸卡巴拉汀胶囊北京诺华制药有限公司国药准字HJ201810442022年07月29日24JYHZ2200076国重酒石酸卡巴拉汀胶囊北京诺华制药有限公司国药准字HJ201810452022年07月29日25JYHZ2200077国注射用醋酸卡泊芬净默沙东研发（中国）有限公司国药准字HJ201712182022年07月29日26JYHZ2200078国注射用醋酸卡泊芬净默沙东研发（中国）有限公司国药准字HJ201712192022年07月29日27JYSZ2100534国注射用重组人凝血因子Ⅷ武田（中国）国际贸易有限公司国药准字SJ201700202022年07月29日28JYSZ2100535国注射用重组人凝血因子Ⅷ武田（中国）国际贸易有限公司国药准字SJ201700212022年07月29日29JYSZ2100536国注射用重组人凝血因子Ⅷ武田（中国）国际贸易有限公司国药准字SJ201700222022年07月29日30JYSZ2100537国注射用重组人凝血因子Ⅷ武田（中国）国际贸易有限公司国药准字SJ201700232022年07月29日

Pfizer’s COVID-19 vaccine data has once again been threatened by hackers. The alleged theft of intellectual property has been laid at the feet of North Korea’s government. According to multiple reports, South Korea’s intelligence agency first reported the latest hacking attempts. It is unclear if North Korean operatives were successful in retrieving any data from Pfizer facilities located in Asia. Also unclear is the timeline of when this alleged hacking occurred. South Korean politician Ha Tae-keung, who is an opposition member of the parliamentary intelligence panel, was the one who made the announcement to news agencies in that country, Reuters reported. “There were attempts to steal COVID vaccine and treatment technology during cyber-attacks and Pfizer was hacked,” he said, according to the report. Pfizer’s offices in Asia and South Korea have not made any comment about the claims from the South Korean government. Cyberattacks are becoming an increasingly serious problem for the pharmaceutical industry, particularly for those companies developing vaccines and therapies for COVID-19. This certainly isn’t the first time North Korea has been implicated in hacking allegations. In December, AstraZeneca was attacked by hackers who attempted to gain COVID-19 research. A North Korean hacking collective known as Kimsuky was thought to be behind the attack. In addition to COVID-19 research, Kimsuky has also attempted to steal national security data. AstraZeneca was not the sole target of that attack. Life sciences giant Johnson & Johnson and Maryland-based Novavax, both of which are developing vaccines against COVID-19, were also targeted. Three South Korean pharma companies, Genexine, Inc., Shin Poong Pharmaceutical Co. and Celltrion Healthcare, were also targets of the scheme. Also in December, the European Medicines Agency said its server was breached by hackers who accessed documents related to the COVID-19 vaccine developed by Pfizer and BioNTech. Hackers gained access to some documents relating to the regulatory submission for Pfizer and BioNTech’s COVID-19 vaccine candidate, BNT162b2, which has been authorized for use in Europe, as well as in the United States and other countries. North Korea is certainly not the only country to have been implicated in the hacking of life sciences data. In July, the U.S. Department of Justice indicted two Chinese hackers for attempting to steal trade secrets, including COVID-19 research from pharma companies. Li Xiaoyu and Dong Jiazhi were charged with probing networks for vulnerabilities in an attempt to steal vaccine research. In 2019, the federal National Counterintelligence and Security Center (NCSC) pegged biotechnology as a rich target for foreign hackers. According to the report, “biomaterials, biopharmaceuticals and new vaccines and drugs as of particular interest” to foreign hackers. Additionally, the government report said hackers are interested in garnering information on advanced medical devices, infectious disease treatment and genetically modified organisms. Most Read Today

Yalcin Sonet / Shutterstock Documents related to the COVID-19 vaccine developed by Pfizer and BioNTech that were in possession of the European Medicines Agency have been accessed by hackers. Germany-based BioNTech, which developed the vaccine under consideration by the U.S. Food and Drug Administration (FDA) and recently authorized for use in the United Kingdom, said it was informed by the EMA of the cyberattack. Hackers gained access to some documents relating to the regulatory submission for Pfizer and BioNTech’s COVID-19 vaccine candidate, BNT162b2. The documents had been stored on a server maintained by the European Medicines Agency. The EMA was in the process of reviewing the vaccine for emergency authorization and is expected to make a ruling later this month. Pfizer and BioNTech’s mRNA vaccine, BNT162b2 demonstrated a 95% efficacy in clinical trials. The U.S. Food and Drug Administration will review the clinical data on Thursday and could grant Emergency Use Authorization within a matter of hours following the review. BioNTech said none of its systems, nor systems operated by Pfizer, were breached in connection with the hacking. The company said it is unaware if any information related to the trial participants were accessed. “At this time, we await further information about EMA’s investigation and will respond appropriately and in accordance with EU law. EMA has assured us that the cyberattack will have no impact on the timeline for its review,” BioNTech said in a statement. As the global health crisis continues, BioNTech said it will continue to provide clarity around all aspects of the vaccine development and regulatory processes. “Our focus remains steadfast on working in close partnership with governments and regulators to bring our COVID-19 vaccine to people around the globe as safely and as efficiently as possible to help bring an end to this devastating pandemic,” the company added. At this time, it is unclear if documents for other vaccines, such as the mRNA vaccine developed by Moderna, were affected in the attack. It is also unclear when the attack occurred, if there were more than one attack on the data and what groups may be responsible. The EMA said it was conducting an investigation into the cyberattack and was cooperating with law enforcement. “EMA cannot provide additional details whilst the investigation is ongoing. Further information will be made available in due course,” the agency said in a brief statement. Cyberattacks are becoming an increasingly serious problem for the pharmaceutical industry, particularly for those companies developing vaccines and therapies for COVID-19. Just last week, AstraZeneca was attacked by hackers who attempted to gain COVID-19 research. A North Korean hacking collective known as Kimsuky was thought to be behind the attack. In addition to COVID-19 research, Kimsuky has also attempted to steal national security data. As BioSpace previously reported, AstraZeneca was not the sole target of that attack. Life sciences giant Johnson & Johnson and Maryland-based Novavax, both of which are developing vaccines against COVID-19, were also targeted. Three South Korean pharma companies, Genexine, Inc., Shin Poong Pharmaceutical Co. and Celltrion Healthcare, were also targets of the scheme. In July, the U.S. Department of Justice indicted two Chinese hackers for attempting to steal trade secrets, including COVID-19 research from pharma companies. Li Xiaoyu and Dong Jiazhi were charged with probing networks for vulnerabilities in an attempt to steal vaccine research. Last year, the federal National Counterintelligence and Security Center (NCSC) pegged biotechnology as a rich target for foreign hackers. According to the report, “biomaterials, biopharmaceuticals and new vaccines and drugs as of particular interest” to foreign hackers. Additionally, the government report said hackers are interested in garnering information on advanced medical devices, infectious disease treatment and genetically modified organisms.