Why did Berry biopharmaceutical mass production of Redsive attract regulatory attention?

Why emphasize experimental or commercial production? What are the potential risks from a legal, compliance perspective? The author tried to parse it.
incident after February 12, Bore Biopharmaceuticals (Suzhou) Co., Ltd. (hereinafter referred to as "Bore Pharmaceuticals") said in a statement that the company has successfully developed the reedsiwe API synthesis technology and preparation technology, and has mass produced Redsiwe API, Redsiwe preparation mass production is under way.
February 12, Berry Pharmaceuticals also said in an interview with the media that the company's Redsiwe production "is not the kind of samples in the laboratory, but can be mass produced."
February 14, Berry Pharma said in a separate announcement: "As of now, the company's development work on Redsiwell is still in the research and development stage."
1st, the SSE decided to take regulatory action against Berry Pharmaceuticals.
The Shanghai Stock Exchange said that after verification, the "mass production" as described in the Berry Pharmaceutical Bulletin is actually the experimental production of small and medium-sized and pilot batches of drug research and development.
SSE, Berry Pharmaceuticals has not obtained the approval of the drug regulatory department, nor has it obtained the authorization of the patente, and does not have the qualifications to carry out commercial mass production of drugs.
the field of pharmaceutical production: experimental production vs. commercial production The author inquired about GMP, GMP implementation guide, Chinese Pharmacopeia, did not find the concept of "mass production".
but in the 2010 version of GMP and appendix found batch, batch, small batch trial production, commercial production nouns or concepts.
: (27) A quantity of raw materials, packaging materials or finished products produced by one or more processes with the expected average quality and characteristics.
to complete certain production operation steps, it may be necessary to divide a batch of products into sub-lots and eventually merge into one batch.
in the case of continuous production, the batch must correspond to a specified quantity of products in production with the expected average characteristics, and the batch may be a fixed quantity or a fixed amount of product produced over a fixed period of time.
e.g., oral or external solid, semi-solid preparations are produced in batches of homogeneous products produced in one batch using the same mixing equipment at one time before molding or sub-packing;
batch trial production: 2010 version of GMP: Article 259 If necessary, samples provided by major material suppliers shall be produced in small quantities, and the stability of the drugs tested for production shall be examined.
Commercial Production: 2010 version of GMP Appendix: Confirmation and verification of "amplification test" in the Pharmacopeia "scale production" China Pharmacopeia 2015 edition of the "9001 API and Preparation Stability Test Guidelines" drug preparation test should be the product of the amplification test, its prescription and process should be consistent with large-scale production.
pharmaceutical preparations such as tablets, capsules, each batch to enlarge the size of the test, tablets should be at least 10,000 tablets, capsules should be at least 10,000 tablets.
large-volume packaging preparations such as intravenous fluids, each batch of large-scale quantity should be at least 10 times the total amount required for each test.
quantity required for special varieties and special dosage form, depending on the circumstances.
Because the magnification test is smaller than the quantity produced on a scale, the filer should undertake that, after testing and long-term stability testing will still be required for the initial production of the three batches of scale production after approval, from the amplification test to the scale production.
as can be seen from the above, the "amplification test" in the Chinese pharmacopeia is often referred to as "pilot" in the industry, while the concept of "scale production" is called "commercial production" in the industry, sometimes referred to as "mass production".
"mass production" referred to by Berry Pharma, because GMP's "mass production" actually refers to "commercial production" of the batch, so "mass production" can easily be understood by the industry as "commercial production".
Patent area: experimental production vs. Commercial production Article 69 of the Patent Law provides for five situations that are not considered to infringe patent rights: (1) a patented product or a product obtained directly in accordance with a patent method, which is sold by the patente or a licensed unit or individual, uses, promises to sell, sell, import the product; (2) the same product has been manufactured before the patent application, the same method has been used, or the necessary preparation for its use continues; (3) The temporary use of the relevant patents in its installations and equipment for the purposes of the transportation of the means of transport, in accordance with the agreements signed or international treaties to which china is a party, or in accordance with the principle of reciprocity; (4) the use of the relevant patents for scientific research and experiments; (5) the manufacture, use, import of patented drugs or patented medical devices for the purpose of providing the information necessary for administrative examination and approval; Importing a patented drug or a patented medical device.
On "The Use of Patents for Scientific Research and Experiments" - The Guidelines for the Determination of Patent Infringement issued by the Beijing Municipal High Court state: "Guidelines for the Determination of Patent Infringement, specifically for scientific research and experiments, refer to scientific research and experiments specifically directed at the patented technology programme itself, with the aim of researching, verifying and improving the patented technologies of others and producing new technological achievements on the basis of existing patented technologies."
" In addition, the State Intellectual Property Office's Guide to Administrative Rulings on Patent Infringement Disputes states: "For scientific research and experimentation, it refers to scientific research and experiments on the patented technology itself, which generally includes: studying the practical effects that patented technology can achieve;
In the course of scientific research and experiments, the manufacture and use of other people's patented technology, if its purpose is not to research and improve other people's patented technology, the result is not directly related to the patented technology, it can not be applied specifically for scientific research and experimental defense, its behavior constitutes a patent infringement.
" means that if it is a laboratory experiment aimed at researching and improving the patented technology of others, it may not constitute infringement;
Compliance of the Securities Market The SSE stated in its decision that the disclosure of bore pharmaceutical information was unclear and inaccurate and violated the relevant provisions of Article 5.1.2, Article 5.1.4, Article 5.2.4, article 5.2.4 of the Shanghai Stock Exchange's Rules for listing stocks on the Board of Science and Technology (hereinafter referred to as the Rules for listing of shares of the Stock Exchange of the Shanghai Stock Exchange).
In accordance with Article 14.2.5 of the Rules for the Listing of Shares of Cote d'Or and the relevant provisions of the Measures for the Implementation of Disciplinary and Regulatory Measures of the Shanghai Stock Exchange, the Regulatory Department of SSE Co., Ltd. has made the following regulatory measures: To pay regulatory attention to Bore Biopharmaceuticals (Suzhou) Co., Ltd.
These provisions are as follows: The relevant provisions of the Shanghai Stock Exchange's Rules for the Listing of Stocks 5.1.2 Listed Companies and Related Information Disclosure Obligations shall disclose information in a timely and fair manner to ensure that the information disclosed is true, accurate and complete.
Directors, supervisors and senior managers of listed companies shall ensure that the company discloses information in a timely and fair manner, and that the contents of the information disclosure are true, accurate and complete, and that there are no false records, misleading statements or material omissions.
directors, supervisors or senior managers have any objection to the contents of the announcement, they shall make corresponding statements in the announcement and explain the reasons.
5.1.4 The disclosure of information by listed companies and related information disclosure obligers shall be objective, shall not be exaggerated, and shall not be misleading.
disclose predictive information such as future operations and financial situation, it shall be reasonable, prudent and objective.
5.2.4 The listed company and the relevant information disclosure obliger believe that the relevant information may affect the price of the company's stock trading or contribute to the investor's decision-making, but is not required by these rules to disclose the information, may be disclosed voluntarily.
the voluntary disclosure of information by listed companies and the relevant information disclosure obligors, they shall be prudent and objective and shall not use such information to improperly influence the price of the company's stock transactions, engage in insider trading or other illegal and illegal activities.
a listed company and the relevant information disclosure obliger disclose information in accordance with this article, in the event of a similar incident, it shall be disclosed in accordance with the same criteria to avoid selective information disclosure.
14.2.2 This Exchange may, in accordance with these Rules and other relevant provisions of this Exchange, take the following regulatory measures against the subject of supervision, depending on the seriousness of the circumstances: (1) oral warning; (2) written warning; (3) regulatory talks; (4) require correction within a time limit; (5) require public correction, clarification or explanation; (6) require the hiring of a sponsor or securities service institution to verify and express its opinion; (8) Requiring a limited period of time to participate in training or examinations; (9) requiring a meeting of investors' notes within a specified period of time; (10) requiring the board of directors of a listed company to recover losses; (11) suspending the trading of shares of a listed company that has not been corrected as required; (12) suspending the application of information disclosure through train business for listed companies that have not been corrected as required; (13) recommending that the listed company replace the relevant personnel; (14) issue a regulatory recommendation letter to the relevant competent departments;15)
14.2.5 If the directors, supervisors and senior managers of a listed company fail to fulfill their duty of loyalty and diligence, or if there are other circumstances in which they violate these rules and make commitments to this Exchange, the Institute may, depending on the seriousness of the circumstances, impose the following disciplinary actions: (1) notify the criticism; (2) publicly condemn; (3) publicly determine that they are not fit to serve as directors, supervisors, senior managers or secretaries of the board of directors of the listed company for more than three years;
to sum up, in the operation of listed companies, whether the information disclosure is true, accurate, prudent, objective, or production, operation of legal, compliance, are worthy of increasing concern of enterprises.
the premise of legal compliance, active innovation and respect for intellectual property rights, it is beneficial for enterprises to reduce risks and "navigation" to be smoother and longer-lasting.
the original title: "mass production" four words, why attracted regulatory attention?