every reporter: Xu libo every editor: Wei guanhong

Diet pills are still hot. On October 13, the concept stocks of weight-loss drugs rose against the trend. Borui Pharmaceutical (SH688166, stock price 37.32 yuan, market value 15.8 billion yuan), Baihua Pharmaceutical (SH600721, stock price 10.19 yuan, market value 3.9 billion yuan), and Zhongsheng Pharmaceutical (SZ002317, stock price 20.05 yuan, market value 17.1 billion yuan) all hit the daily limit.

In the evening of the same day, Borui Pharmaceutical disclosed a stock trading risk warning announcement that the company's stock rose 20% on October 13; since September 25, the company's closing price has risen 57.91 percent. The company's fundamentals have not changed significantly, and there is no material information that should be disclosed but not disclosed.

it is reported that at the company's investor conference call on October 12, yuan Jiandong, chairman of borui pharmaceutical, said that the weight of the weight loss drug (BGM0504 injection) developed by the company in person had dropped from 91kg to 76kg. An institutional analyst who participated in the above-mentioned conference call confirmed the matter to the "Daily Economic News" reporter.

Borui Pharmaceutical said in an announcement that night that BGM0504 injection is still in the research and development stage. Up to now, the two indications for weight loss and type 2 diabetes treatment have only obtained ethical approval documents for phase II clinical trials, among which phase II clinical trials for type 2 diabetes treatment have begun to enter the group. After the completion of the phase II clinical trial, it is necessary to confirm the confirmatory clinical trial scheme by the State Food and Drug Administration, carry out and complete the phase III clinical study, and be reviewed and approved by the State Food and Drug Administration before production and listing.

the chairman of the board "tested the drug with his own body" and said the effect was remarkable

Since the birth of Novo Nordisk's smaglutide (trade name: Wegovy), weight loss drugs have become one of the hottest tracks in the biomedical field.

In terms of market size, JPMorgan expects that by 2030, the annual sales of GLP-1 (glucagon-like peptide -1) receptor agonist-related drugs will exceed $100 billion. JPMorgan Chase also predicts that China's weight-loss drug market is expected to reach $14.9 billion billion by 2030.

Stimulated by the stunning commercial performance of weight-loss drugs, domestic pharmaceutical companies are also tending to roll in the research and development of GLP-1 weight-loss drugs. According to the research report of Debang Securities, as of June 14 this year, a total of 99 GLP-1 drugs have been applied for clinical and above in China, and 10 innovative drugs have been approved for listing. Domestic pharmaceutical giants such as Hengrui Pharmaceutical, East China Pharmaceutical and Shiyao Group have also entered the market. At the same time, from the number of IND declarations, GLP-1 drugs in the past three years of clinical declaration has been in the outbreak period. In the first half of 2023 alone, the number of clinical applications has reached 47, which has exceeded the 35 for the whole of last year, which is enough to see the hot research and development of GLP-1 new drugs.

Data show that BGM0504 injection is a dual agonist of GLP-1 and GIP (glucose-dependent insulinotropic polypeptide) receptor independently developed by Borui Medicine. It can stimulate GIP and GLP-1 downstream pathways, produce biological effects such as blood sugar control, weight loss and treatment of nonalcoholic steatohepatitis (NASH), and show therapeutic potential for various metabolic diseases. The company's 2023 semi-annual report disclosed that the total investment scale of BGM0504 injection is expected to be 60 million yuan, and the company has invested 34.0745 million yuan in the development of the drug.

According to market sources, Yuan Jiandong pointed out on the conference call, "I'm not so worried about safety. Then I said I would try the medicine I made myself, and I tried it, and the effect was good. I probably played for almost two months, and it dropped from 91kg to 76kg, and the effect was still very obvious".

In terms of drug targets and mechanisms, BGM0504 injection is similar to Lilly's Tirzepatide (telpotide), and both are GLP-1/GIP dual receptor agonists. According to the interface news report, on October 13, the staff of Borui pharmaceutical investment customs said that the self-developed polypeptide hypoglycemic drug BGM0504 injection was still in the research and development stage, and the two indications of weight loss and type 2 diabetes treatment were only approved by phase II clinical trial ethics. Regarding the chairman's personal claim on the efficacy of the drug, the staff member said that the individual situation cannot represent clinical trial data.

in addition, according to the investor research report disclosed by borui medicine on the 12th, the preliminary data of phase Ia clinical trial of BGM0504 injection show that GM0504 injection is safe and well tolerated. all adverse reactions in the dose escalation range of 2.5mg-15mg are grade 1-2, no adverse reactions of grade 3 or above are observed, and the exposure (Cmax and AUC0-t) is higher than that of equal dose Tirzepatide (literature data), with a linearly scaled dose-response relationship. In addition, a dose-related reduction in body weight was observed for pharmacodynamic measures, with mean body weight at the end of the follow-up period (day 8/15) at 2.5mg to 15mg decreased by 3.24 to 8.30 percent from baseline.

the research report also said that considering that GLP-1 overactivation is easy to bring a series of related side effects, in order to take into account the efficacy and safety, borui medicine appropriately reduced the GLP-1 activity but increased the GIP activity, and balanced some side effects brought by GLP-1 with GIP. In terms of drug molecular design, the company found that there is room for improvement in the side chain structure and connection site of GLP-1 and GIP dual-target molecules, and believes that it can try to provide drug activity and improve pharmacokinetic characteristics by optimizing the side chain structure and adjusting the side chain modification site.

Are you suspected of violating the letter?

At present, the focus of the market debate is: under the background that the BGM0504 is still in the early clinical stage, Yuan Jiandong, chairman of Borui Pharmaceutical, "tested the drug by himself" and introduced the individual situation of taking the drug to the investors participating in the company's conference call, which objectively or promoted the rise of the company's stock price. Does this involve violation of the trust and disclosure?

To this end, the "Daily Economic News" reporter conducted multiple consultations. Wang Zhibin, a lawyer from Shanghai Minglun law firm, told reporters that listed companies should disclose important information in designated media, and the chairman of the company should release information about drug efficacy on his own, which is suspected of constituting a violation of information disclosure.

Lawyer Wang Zhibin also stated that relevant departments have put forward stricter requirements on the information disclosure of listed companies in recent years, mainly to strengthen information disclosure in the process of transforming the old and new ecology of the capital market to allow participants to adapt to the new ecology. Moreover, with the evolution of the market, many rules have also changed, which will be shown in information disclosure, listed companies and relevant responsible persons should "update" their knowledge in time, strengthen learning, and avoid the phenomenon that information disclosure is always "patched.

in addition, the chief medical officer of a domestic Biotech (biotechnology) enterprise told the reporter: "if the drugs in the research and development stage are not used by subjects (including healthy people and patients) at will according to the national GCP (drug clinical trial management standard), it is definitely wrong, but the chairman is a personal behavior, and his medication is definitely not within the scope of national management of research and development trials, at most, it is the internal management problem of the enterprise, but if the purpose of the relevant behavior and report is for the stock market, or causes abnormal fluctuation of the stock price, then whether the relevant securities regulatory department thinks that the behavior is improper or within the scope of its permission, this should be confirmed by them."

It is worth mentioning that Borui Pharmaceuticals has previously received a warning letter from the regulatory authorities for violating the letter. (Details can be found in the daily economic news report: using the listed company involved in the new crown drug insider trading, under the "Ben" tens of millions of profit 860000, he was sentenced to five years in the first instance )

According to the news previously released by the official account of the Shanghai Third Intermediate People's Court (hereinafter referred to as the Shanghai Third Intermediate People's Court), the Shanghai Third Intermediate People's Court found out after trial that a biomedical company (I. e., Borui Pharmaceuticals) is a company listed on the Shanghai Stock Exchange's Science and Technology Innovation Board. In January 2020, the company carried out the imitation of the antiviral drug Redsivir in response to the outbreak of the new crown virus, and completed the production of small and pilot batches on February 1 and February 11 of the same year. On the evening of February 11, the company announced that it had successfully developed the synthesis technology and preparation technology of racetivir bulk drug by imitation, and had produced racetivir bulk drug in batch.

affected by this good news, Borui Pharmaceutical's share price rose by more than 50% in the following three trading days.

However, after verification, the "mass production" referred to in the announcement of Borui Pharmaceuticals is actually the experimental production of batches of drug research and development, such as small and medium-sized trials and pilot trials, rather than the approval has been completed and the formal large-scale, commercial production and sales of raldisevir raw materials and preparations have been completed. After that, the Shanghai Stock Exchange decided to pay regulatory attention to Borui Pharmaceuticals, and the Jiangsu Securities Regulatory Bureau also issued a warning letter to Borui Pharmaceuticals.

In response to the chairman's "test drug by body", the reporter sent an interview letter to Borui Pharmaceutical on October 13 and called the company's securities affairs department several times, but the call was not answered.

Daily Economic News