Is the mass-produced Ridsiewe blowing? Berry Pharma is regulated for attention

On March 1, the Regulatory Department of The Shanghai Stock Exchange’s Science and Technology Board Company made a regulatory decision on Berry Biopharmaceuticals (Suzhou) Co., Ltd. (688166, Berry Pharmaceuticals). SSE disclosed that, after the investigation, Berry Pharmaceuticals on February 12, 2020 disclosed “on the progress of antiviral drug development announcement” that the company has successfully developed the Redsiwe API synthesis process and preparation technology, and has mass produced Redsie weer raw materials, Redsiwe preparations in bulk production is under way.

After verification, the company’s announcement “mass production” is actually a drug research and development of small and medium-term test, pilot and other batches of experimental production. The company has not yet obtained the approval of the drug regulatory department, nor has obtained the patentee’s authorization, and does not have the proper qualifications for the commercial production of drugs.

Is the mass-produced Ridsiewe blowing? Berry Pharma is regulated for attention

SSE believes that in the relevant information disclosure, Borui Pharma has made a risk warning on the major uncertainties such as clinical trial results, regulatory approval and patent licensing faced by the relevant drug research and development production, but has failed to make a clear distinction between the experimental and commercial production of relevant drugs, and the “mass production” disclosed actually belongs to the drug research and development stage. Instead of having completed the approval and starting the formal production and sale of Ridsyway API and preparation, the disclosure is unclear and inaccurate.

To sum up, the SSE believes that the disclosure of the information of Borui Pharmaceuticals is not clear and inaccurate, in violation of the relevant provisions of the Shanghai Stock Exchange Science and Technology Board Stock Listing Rules, the Regulatory Department of ssE Cotron Board Company has paid attention to the supervision of Borui Pharmaceuticals. The company shall be taken as a cautionary notice to regulate its operation and conscientiously fulfill its obligation severance of information disclosure in strict accordance with laws, regulations and the Rules of the Science and Technology Board Stock Listing Rules, and the directors, supervisors and senior managers shall fulfill their duty of faithful diligence to promote the company’s ability to regulate its operation and ensure that the company discloses material information truthfully, accurately, completely, promptly and fairly.

In addition to Berry Pharma, the SSE also informed Wang Zhengye, then secretary of the board of directors of Bory Pharmaceuticals, of the disciplinary action against him.

According to the SSE disclosure, it was found that on February 12, 2020, The then secretary of the board of directors of Berry Pharmaceuticals Wang Zhengye said in an interview with the media that the company’s research and development and production of Redsiewe raw materials and preparations, certainly not the kind of laboratory samples, but can be mass-produced. Earlier in the same day, the company disclosed “on the progress of antiviral drug development announcement” said that the company has successfully developed the Redsiwe API synthesis process and preparation technology, and has mass produced Redsiwe API, Redsiwe preparation series production is under way.

After verification, the “mass production” referred to in the Bory Pharmaceutical Bulletin is actually a pilot production of small and medium-sized test, pilot and other batches of drug research and development. The company has not yet obtained the approval of the drug regulatory department, nor has obtained the patentee’s authorization, does not have the due qualifications for the commercial production of drugs. In the relevant information disclosure, the Company failed to make a clear distinction between the pilot production and commercial production of the relevant drugs, the disclosure of “mass production” actually belongs to the drug research and development phase, rather than the completion of the approval and the commencement of the formal production and sale of Redsie weeds and preparations. Wang Zhengye’s statement in an interview with the media further confuses the experimental production and commercial production, and the relevant statement is not clear and inaccurate.

To sum up, the SSE believes that Wang Zhengye, as the specific person in charge of the company’s information disclosure, is responsible for the violation of the disclosure of information by the company, and that his statement to the public media is unclear and inaccurate, in violation of the relevant provisions of the Shanghai Stock Exchange Science and Technology Board Stock Listing Rules and its statements and commitments in the Directors (Supervisors, Senior Managers) commitments.

Remdesivir, an experimental antiviral drug being developed by Gilead, has shown some hope of fighting other coronaviruses that cause SARS and MERS, having previously completed Phase II clinical trials overseas, but has not yet been tested on human coronaviruses. Since the outbreak, some studies have found that the drug has potential to treat new coronary pneumonia, so a clinical phase III trial is being conducted in China for patients with new coronary pneumonia.

On February 26th, the company learned from Gilead Sciences that the company’s global clinical trial of Redsiewe for the treatment of new coronary pneumonia would be released as soon as May.

The new clinical study also includes two clinical trials already led by the China-Japan Friendship Hospital in Hubei, China, and, more recently, a clinical trial led by the National Institute of Allergy and Infectious Diseases (NIAID) in the United States. Gilead has donated drugs to the research institutions and provided scientific support for the research, which is expected to be published in April.