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On May 15, Baili Tianheng-U (688506.SH) issued an announcement, saying that the company received a regulatory work letter, involving listed companies, directors, supervisors, senior managers, intermediaries and related personnel.
However, for the specific content of the regulatory letter and related reasons, Baili Tianheng did not specifically disclose it. In this regard, Titanium Media APP contacted the relevant people of the company and learned that the reason for the constant receipt of the regulatory letter by Baili Tianheng is that the company and Bristol-Myers Squibb (referred to as BMS, BMY. US) has been questioned by investors.
The above-mentioned "BMS-related transactions" are the license-out (overseas licensing) transactions reached between SystImmune, a wholly-owned subsidiary of Baili Tianheng, and BMS on the BL-B01D1 (EGFR×HER3 bispecific antibody ADC) project in December last year, with a potential total transaction value of up to US$8.4 billion, and the company received a down payment of US$800 million in March this year, pushing the company to turn losses into profits in the first quarter, with a profit of more than 5 billion yuan in the first quarter.
Today, this "report card" is being questioned.
巨额license-out交易遭到质疑
Back on December 12, 2023, Baili Tianheng announced that its wholly-owned subsidiary, SystImmune, and BMS reached an exclusive license and cooperation agreement, and the cooperation revolved around the BL-B01D1 project.
According to the announcement, BMS will make an upfront payment of $800 million, up to $500 million in near-term contingent payments, and up to $7.1 billion in milestone additional payments to SystImmune, for a potential total transaction value of up to $8.4 billion.
This is the license-out transaction with the highest prepayment and total potential transaction value in China, and it is also the first bispecific antibody ADC drug in mainland China to go overseas. On March 11 this year, the company announced that as of March 7, the company had received an upfront payment of $800 million from BMS.
This huge license-out transaction is like a "timely rain" for Baili Tianheng, which quickly raised a huge amount of funds for its innovative drug research and development, and also solved the company's urgent needs, and pushed the company's market value and performance to rise significantly.
According to the first quarterly report, the company achieved revenue of 5.462 billion yuan in the first quarter of this year, a year-on-year increase of 4325.45%; In the same period, the net profit was as high as 5.005 billion yuan, a year-on-year turnaround. It was also the company's first earnings season since going public.
In terms of market capitalization, as of the close of trading on May 15, the company's total market value was as high as 77.8 billion yuan, which has increased significantly compared with the market value of about 43.8 billion yuan on the eve of the disclosure of the above-mentioned license-out transaction.
Judging from the above performance and market capitalization fluctuations, the importance of this license-out transaction can be seen. However, now this huge deal has caused investors to question and the relevant authorities have issued a regulatory letter.
In this regard, Baili Tianheng said on the investor interactive platform, "The regulatory work letter received by the company this time is a working letter from the exchange to understand the daily operation of listed companies, and it is not a violation of the company, nor does it involve any form of disciplinary punishment or administrative punishment." ”
A relevant person of the company also said: "Due to the large increase in net profit in the first quarter, some investors questioned the authenticity of the company's performance, reported to the exchange, and the exchange made routine inquiries, which was not a violation of the company, nor did it involve any form of disciplinary action or administrative punishment; The Company failed to disclose the specific content of the Regulatory Letter if it did not meet the relevant disclosure standards. ”
Bispecific antibody ADC has the hidden danger of "miscarriage", and the risk of "return" is still there
In recent years, the heat wave of bispecific antibody ADC drugs has set off, and many innovative drug giants are chasing research and development, but the ensuing toxicity problem is particularly worth pondering. As the first bispecific antibody ADC drug to go overseas in mainland China, the BL-B01D1 (EGFR×HER3 bispecific antibody ADC) project is also facing related risks.
Although compared with monoclonal antibody drugs, bispecific antibody ADC drugs have the advantages of "targeting tumor cells more specifically, overcoming drug resistance, and reducing side effects", but this series of drugs has a very high "miscarriage rate" like other innovative drugs.
For example, AstraZeneca's (AZN.US) HER2 ADC project, which MEDI4276 biepitope tetravalent, was terminated due to toxicity issues.
Focusing on the HER3 therapy of Baili Tianheng's overseas project, it is more difficult to develop it. Up to now, there have been a number of HER3 projects in the world, among which Duligotuzumab, which is the same EGFR×HER3 bispecific antibody as the Baili Tianheng project, finally failed due to the high incidence of serious adverse reactions and insufficient efficacy.
And the risk of "return" caused by project failure should not be underestimated. In recent years, due to the failure of the FDA, the failure of clinical trial data and the adjustment of R&D pipelines, many Chinese pharmaceutical companies have encountered "returns" from overseas pharmaceutical giants for their license-out projects. From BeiGene (688235. SH) PD-1 monoclonal antibody parted ways with Novartis and went to Junshi Biosciences (688180. SH) terminated the cooperation with Coherus BioSciences on the recombinant humanized anti-TIGIT monoclonal antibody project, and according to incomplete statistics, more than 10 innovative drug license-out projects have been "returned" in the past three years.
Baili Tianheng also admitted the risks in the relevant announcement: "Drug research and development is susceptible to some uncertainties, and the milestone payment agreed in the cooperation agreement needs to meet certain conditions, and there is still uncertainty in the final milestone payment." ”
It is worth mentioning that Baili Tianheng recently said that it plans to go to Hong Kong stocks to sprint for IPO.
On May 14, Baili Tianheng said that in order to further help the development of the company's international business, make better use of domestic and overseas financing platforms, consolidate the company's rapid development of capital reserves, support the global development of many innovative products in Europe, the United States, Japan and other international markets, and vigorously promote the implementation of the company's strategy of growing into a multinational pharmaceutical company (MNC) with global leading advantages in the field of oncology drugs, the company is discussing with relevant intermediaries the relevant work related to the company's issuance of H shares and listing on the main board of the Hong Kong Stock Exchange.
As of now, the relevant matters are still under discussion, and the specific details of the H-share issuance have not yet been determined.
(This article was first published in the Titanium Media APP, by |.) Zhang Haixia)