Controversies
Controversies tied to this brand in public sources. A listing is not a finding of fault.
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2022
La Jolla Pharmaceutical sues over Giapreza patents
Lawsuit filed
La Jolla Pharmaceutical Company, La Jolla Pharma, LLC, and George Washington University filed a case against Gland Pharma Limited, Shanghai Fosun Pharmaceutical Group Co LTD, and Fosun Pharma USA Inc., alleging patent violations related to Giapreza.
Source excerpt
The case is regarding violation of the patents for Giapreza.
On Tuesday a case was filed in the District of New Jersey by La Jolla Pharmaceutical Company, La Jolla Pharma, LLC, and George Washington University against Gland Pharma Limited, Shanghai Fosun Pharmaceutical Group Co LTD and Fosun Pharma USA Inc.
2021
BioNTech vaccine batch paused in Hong Kong and Macau after vial-cap defect
Hazard disclosure
BioNTech notified Fosun Pharma of a vial-cap defect in BNT162b2 batch 210102 supplied to Hong Kong and Macau. BioNTech and Fosun Pharma began investigating the cause, and the batch was paused for vaccination until the investigation ends; Fosun Pharma also said batch 210104 intended for Hong Kong would be stored and not sent to vaccination sites pending further notice.
Stated objective. To ensure vaccination safety.
Company response
Investigation — BioNTech
BioNTech和公司已发起对该问题的原因调查
Investigation — 复星医药
BioNTech和公司已发起对该问题的原因调查
Source excerpt
BioNTech和公司已发起对该问题的原因调查,并已于3月24日通知中国香港及澳门相关主管部门暂停接种批号为“210102”的该疫苗,直至调查结束。
BioNTech注意到其生产供应中国香港和澳门的批号为“210102”的该疫苗产品中存在少量西林瓶封盖有关的瑕疵。
出于谨慎性考虑,用于供应中国香港的批号为“210104”的该疫苗产品也将进行封存,不再发送至各接种点,直至另行通知。
2020
Ministry of Finance's Major Pharma Audit: Subsidiary Fined Over Promotion Fee Invoices
At the end of 2020, the Ministry of Finance announced the results of accounting information quality inspections in the pharmaceutical industry; Fosun Pharma subsidiary Jiangsu Wanbang and others were penalized (fined 50,000 yuan) for issues including using false invoices to expense promotion fees, while China Resources, Buchang and other drugmakers were also named. Media questioned whether false invoicing concealed commercial bribery funds. Fined and ordered to rectify.
2020
Pfizer responds to controversy over China’s exclusion from vaccine collaboration
Company response
In March 2020, Pfizer addressed controversy over the exclusion of China from its COVID-19 vaccine collaboration with BioNTech. Pfizer stated that the collaboration did not include China because BioNTech had already partnered with Fosun Pharma for the Chinese market. Pfizer said it was working to resolve details and was committed to access to medicines and vaccines for patients in China and globally.
Pfizer said its collaboration with BioNTech did not include China because BioNTech had already partnered with Fosun Pharma for the Chinese market. Pfizer said it was working to resolve details and was committed to access to medicines and vaccines for patients in China and globally.
Stated objective. Ensure global access to a safe and effective vaccine if the collaboration produces one.
Company response
Clarification — 辉瑞
辉瑞在声明中表示,如果辉瑞与BioNTech的合作最终创造出一种安全有效的疫苗,其目的和意图是确保全球范围内获得疫苗。
Source excerpt
辉瑞在声明中表示,如果辉瑞与BioNTech的合作最终创造出一种安全有效的疫苗,其目的和意图是确保全球范围内获得疫苗。鉴于形势的严峻性以及COVID-19在全球的蔓延速度,我们仍在努力解决细节问题,我们致力于为中国以及全球的患者提供获得优质药物和疫苗的机会。
3月19日,辉瑞生物制药集团(以下简称辉瑞)在官网发布声明称,近日,辉瑞公司和BioNTech SE宣布,两家公司已就共同开发和分销一种潜在的基于mRNA的冠状病毒疫苗达成意向书,以预防COVID-19感染。在此之前,BioNTech已宣布与复星医药合作开发中国市场。因此,辉瑞与BioNTech的协议不包括中国市场。
2018
Subsidiary Has Drug GMP Certificate Revoked for Violations
In 2018, Chongqing Pharmaceutical Industry Research Institute, a controlled subsidiary of Fosun Pharma, violated drug GMP rules because it changed the production process for aripiprazole API without filing as required; the Chongqing drug regulator warned it, revoked its GMP certificate and ordered rectification. The investigation said the three related products were quality-qualified; the incident occurred during a period of tighter drug regulation after the Changchun Changsheng vaccine scandal.