How does Fosun Pharma respond to reports from employees?

Being reported by employees is another "Changchun Changsheng" Fosun Pharma responded.

Fosun Pharmaceuticals (600196), which was reported by employees to be another "Changchun Changsheng Biotechnology", issued relevant instructions as scheduled last night, regarding its subsidiary companies that were exposed to illegal production of drugs and fabricated production records and inspection records. Explain one by one.

The Fosun Pharma reporting scandal that attracted media attention originated from a reporting message released on the open mailbox of Chongqing Food and Drug Administration on August 24. Internal employees of Chongqing Medical Institute reported that Chongqing Medical Institute Pharmaceutical Co., Ltd. (hereinafter referred to as "Chongqing Medical Institute Pharmaceutical Company") violated national drug production management regulations, even worse than Changchun Changsheng Biotech.

The internal employee report letter stated that the company's production quality management has been very chaotic in recent years, and its leaders have ignored drug production management regulations and taken the lead in committing fraud.

For example, the employee pointed out that "almost all production processes of Chongqing Medical Engineering Institute are not produced according to approved processes", "leaders lead employees to fabricate a large number of production records and inspection records", and "deceive superior drug supervision Management departments, defrauding pharmaceutical GMP certificates" and other behaviors.

The open letter also disclosed that taking aripiprazole, a product mainly supplied to Shanghai Chinese and Western Pharmaceuticals, as an example, the process was not only not produced according to the state-approved process, but was discovered by the US FDA during an on-site inspection in November 2017. In order to seriously violate drug management regulations, "when shipping and responding to the second inspection, the leader requested to reduce the integral area calculation of the map to control the qualified products to leave the factory."

In addition, the open letter also disclosed that during the relocation period, due to the inconsistency between the actual production process and the approved process, Chongqing Medical Engineering Institute used old equipment when applying for site transfer and GMP certificate from the Chongqing Food and Drug Administration. The process was to compile complete sets of production and inspection records to deceive superior authorities and inspectors. At the same time, the employee also claimed that "due to fraud and other reasons", the company was inspected by the US FDA in May 2016 and November 2017, and received "warning letters" and "worst evaluation results (OVI)" respectively.

On the evening of August 30, Fosun Pharma issued a special announcement on the contents of the report letter, and stated that the Chongqing Food and Drug Administration had launched an investigation into Chongqing Pharmaceutical Industry Research Institute Co., Ltd. (referred to as " Chongqing Medical Engineering Institute") conducted an unannounced inspection, and the inspection results are yet to be concluded.

According to information released by Fosun Pharma and the official website of Chongqing Medical and Engineering Institute, the reported pharmaceutical company Chongqing Medical and Engineering Institute holds 70.377 shares, and another shareholder, China Development Bank Development Fund, holds 29.63%. . Chongqing Medical Engineering Institute was established in 1950. It was the only professional research and development institution in Southwest China that was mainly engaged in the research and development of chemical drugs. In 2001, as one of the first batch of scientific research institutes in Chongqing to be transformed, Chongqing Pharmaceutical Industry Research Institute Co., Ltd. (today’s Chongqing Medical Research Institute) was jointly established by Shanghai Fosun Pharmaceutical Industry Development Co., Ltd. and Chongqing Pharmaceutical (Group) Co., Ltd. Institute of Technology). Currently, Fosun Pharma holds 56.89% of the shares of Chongqing Medical Institute and is the controlling shareholder. It is reported that Chongqing Medical Engineering Institute and Chongqing Medical Engineering Institute Pharmaceutical are mainly engaged in the research and development, production and sales of generic drug APIs and intermediates. Their main customers are European, American and Chinese preparation companies.

In 2017, Chongqing Medical Institute (on a consolidated basis) achieved operating income of RMB 77.8 million, accounting for 0.42% of Fosun Pharma’s operating income in 2017; it achieved a net profit attributable to the parent company of RMB -34.61 million.

Among them, overseas sales revenue accounts for about 26%.

Fosun Pharma’s specific instructions are as follows:

1. In 2016, the U.S. FDA inspected the factory of Chongqing Medical Institute and issued a warning letter and put forward rectification requirements for insufficient standardization of laboratory data. . Fosun Pharma stated that in accordance with the rectification requirements, it has seriously dealt with and adjusted the then main leaders and relevant persons in charge of Chongqing Medical Engineering Institute, and is actively promoting relevant rectification work.

2. In November 2017, the US FDA conducted a pre-approval inspection of the pharmaceutical quality system of the Medical Engineering Institute.

After the inspection, a 483 defect was raised for the API aripiprazole. This defect was mainly due to the insufficient invalid OOS (Offset Investigation) generated during the detection of aripiprazole. At present, Medical Industry Pharmaceutical has started rectification under the guidance of the FDA.

3. According to the pharmaceutical self-inspection of the Medical Engineering Institute, existing products are produced according to approved processes. During the production process, adjustments to the production process are subject to approval or filing by the relevant drug regulatory authorities.

4. Chongqing Medical Engineering Institute transferred product approval documents for aripiprazole and pemetrexed disodium to Chongqing Medical Engineering Institute Pharmaceuticals in 2016, and transferred product approval documents for iron sucrose in 2018, which have been approved by the pharmaceutical industry. On-site inspection and approval by the supervisory authority.

5. Aripiprazole, the raw material drug of Medical Engineering Institute Pharmaceutical, is currently applying for a process change. The product provided to Shanghai Zhongxi Sanwei Pharmaceutical Co., Ltd. in 2018 is only used for its formulation research.

6. The Chongqing Food and Drug Administration has carried out relevant investigations into the content reflected in the letter, and conducted an unannounced inspection of Chongqing Medical Engineering Institute on August 23, 2018. The results of the unannounced inspection are yet to be determined. Concluding comments awaited.

Source: Southern Metropolis Daily (Shenzhen)