Borey Pharmaceutical's GLP-1 product clinical data shocks the market: Directly challenging semaglutide?

The strong wind of GLP-1 has already driven several bull stocks, such as the recently popular 常山药业. According to 东方财富 choice data, from September 4, 2023, to June 20, 2025, the stock has increased by more than 10 times. The driving force behind 常山药业 is a long-acting glucagon-like peptide-1 receptor (GLP-1R) agonist—艾本那肽。

Similarly, 博瑞医药 has also surged due to the popularity of GLP-1 drugs. In 2023, 博瑞医药's chairman 袁建栋 stated in an investor conference call that he personally tested the company's weight loss drug BGM0504, and after nearly two months, his weight "dropped from 91 kg to 76 kg." After the news was released, 博瑞医药's stock price rose by more than 38% in three trading days, and its market value exceeded 18 billion yuan. As of today's publication, 博瑞医药's stock price has exceeded 50 yuan, and its market value is over 20 billion yuan.

However, "oral efficacy" clearly lacks credibility, and market recognition of a drug is mainly based on reliable clinical trial data; otherwise, "bubbles" will dominate. Recently, we have also seen more prominent phase results in 博瑞医药's new drug development.

On June 24, at the 85th scientific meeting of the American Diabetes Association (ADA), 博瑞医药 announced the phase II clinical research data of its independently developed glucagon-like peptide-1 receptor (GLP-1R)/glucose-dependent insulinotropic polypeptide receptor (GIPR) dual-target agonist BGM0504, as well as the preclinical research results of the new Amylin (胰淀素) BGM1812.

From this, it can be seen that 博瑞医药 is becoming more determined on its transformation path.

Benchmarking against Semaglutide, 博瑞医药's GLP-1 ambition

The benchmarking signal is quite obvious in the answer sheet 博瑞医药 submitted this time.

Let's specifically talk about the clinical performance of the drug BGM0504.

It is reported that in the phase II clinical study for the treatment of type 2 diabetes (CTR202232464, a multicenter, randomized, placebo double-blind and positive drug open parallel controlled clinical study), the positive control drug for BGM0504 injection is Semaglutide injection (1.0 mg).

The main endpoint results show that the HbA1c (glycated hemoglobin) reduction in the three dose groups of BGM0504 is significantly better than the placebo group and preliminarily better than the Semaglutide positive control group: 5mg group -1.72%, 10mg group -1.94%, 15mg group -2.48%, control group -1.43%, placebo group -0.28%.

Secondary endpoint indicators such as PPG-2h (postprandial 2-hour blood glucose), FPG (fasting blood glucose), weight, HbA1c target achievement rate, etc., all show similar trends, and indicators such as HOMA2-B/IR (homeostasis model insulin secretion index/insulin resistance index), blood lipids, blood pressure, etc., also show different improvement trends, especially in blood pressure improvement, showing good antihypertensive effects.

In addition, adverse events during BGM0504 treatment are mostly grade 1-2, with common gastrointestinal reactions such as diarrhea, nausea, and bloating, but no hypoglycemia or other unexpected adverse reactions occurred.

In the phase II clinical trial for overweight or obese subjects without type 2 diabetes (CTR20233198, also a multicenter, randomized, double-blind, placebo parallel controlled clinical study), BGM0504's weight loss effect is also relatively impressive, with significant weight reduction in each dose group compared to the placebo group after 24 weeks of administration, and related lipid metabolism/cardiovascular indicators also show varying degrees of comprehensive benefits.

It is worth mentioning that the drug BGM1812 also adds a layer of weight loss guarantee to BGM0504. ADA preclinical data show that in the diet-induced obesity (DIO) rat model, the combination of BGM1812 and BGM0504 initially shows better weight loss sustainability and efficacy intensity than the combination of Semaglutide + Cagrilintide (a new long-acting amylin analog).

博瑞医药 believes: "These phase II data highlight the potential of BGM0504 as a first-tier international drug for the treatment of type 2 diabetes and obesity, including its possible superior efficacy and good safety performance compared to Semaglutide."

"First-tier international potential" and "possibly superior to Semaglutide" undoubtedly anchor a huge growth space for BGM0504.

According to the "Global Diabetes Map" released by the International Diabetes Federation (IDF), by 2024, the number of adult diabetes patients aged 20-79 worldwide will reach 589 million, accounting for 11.1% of the total population in this age group. Among them, the total number of diabetes patients in China is 148 million, and 274 million people are in the pre-diabetes stage (117 million people have impaired fasting glucose, and 157 million people have impaired glucose tolerance).

In addition, the "2025 World Obesity Map" published on the World Obesity Federation website predicts that the global obese adult population will increase from 524 million in 2010 to 1.13 billion in 2030, an increase of more than 115%; by 2030, the number of overweight/obese adults in China will exceed 500 million.

诺和诺德 has also captured the needs of the above-mentioned population, launching products such as Semaglutide to gain a first-mover advantage and seize a huge market. Financial reports show that in the first quarter of 2025, 诺和诺德's Semaglutide sales reached 55.776 billion Danish kroner (calculated at 1 Danish kroner = 0.1506 USD, approximately 8.4 billion USD), a year-on-year increase of 32%, surpassing 默沙东's Pembrolizumab (commonly known as "K drug"), temporarily topping the global "drug king" list.

Such achievements are enviable, and 博瑞医药 and other pharmaceutical companies are still accelerating their pursuit.

Currently, the drug BGM0504 has already conducted phase III clinical trials for weight management and type 2 diabetes in China and completed US bridging clinical research in the United States. 博瑞医药 has reached a critical point where it must "take a gamble."

Behind the GLP-1 push, some sections of the raw material drug segment show fluctuations

Currently, 博瑞医药 is focusing on GLP-1 drugs, driven by both market attraction and internal motivation.

It is understood that 博瑞医药's revenue pillar has always been raw material drugs.

Financial reports show that the revenue from this business increased from 386 million yuan in 2019 to 885 million yuan in 2023, with a CAGR (compound annual growth rate) of 23.04%; in 2024, 博瑞医药's revenue was 1.283 billion yuan, a year-on-year increase of 8.74%, of which raw material drug business income was 988 million yuan, a year-on-year increase of 11.57%.

Judging from the above data alone, 博瑞医药's raw material drug business has always maintained an upward trend, but the sub-segments have already shown fluctuations, the most obvious being the antiviral category. According to the financial report, in 2024, 博瑞医药's antiviral product income decreased by 37.92% compared to the same period last year, mainly due to the impact of changes in flu trends, and the demand and price of Oseltamivir raw materials fluctuated.

Entering the first quarter of 2025, the demand for Oseltamivir raw materials continued to be sluggish, and 博瑞医药's antiviral product income decreased by 70.08% compared to the same period last year, which also led to a 26.69% year-on-year decline in raw material drug product income.

Although 博瑞医药 started with specialty raw materials and pharmaceutical intermediates, and while expanding and strengthening the specialty raw material drug industry, it continues to extend to the downstream formulation field to open up greater growth space, the positive impact has not occurred in the antiviral field. In the first quarter of this year, the company's formulation product income decreased significantly by 24.40% year-on-year to 42.7762 million yuan, 博瑞医药 explained that this was mainly due to the decline in demand and price for Oseltamivir formulations.

Due to the continuous obstruction of core product volume, 博瑞医药's overall performance has also shown more obvious deterioration. According to the financial report, in the first quarter of 2025, the company achieved revenue of approximately 249 million yuan, a year-on-year decrease of 26.81%; the net profit attributable to shareholders of the listed company was approximately 12.96 million yuan, a year-on-year decrease of 79.77%.

Of course, the significant decline in net profit is also closely related to the company's continued increase in research and development of GLP-1 drugs and other higher value-added products. Financial reports show that in the first quarter of 2025, 博瑞医药's research and development investment increased by 25.42% year-on-year, and the proportion of research and development investment in operating income reached 24.31%.

But the opportunity for transformation has come, and 博瑞医药 must seize it. If it can break through the competition window as a dark horse, the company still has hope to start a new round of performance upward period.

Moreover, 博瑞医药 has certain advantages in focusing on innovative drugs, such as having a "starting material → high-difficulty intermediate → specialty raw material drug → formulation" full industry chain foundation, sufficient drug development experience, and providing certain support for the research and development of innovative drugs such as BGM0504 and BGM1812.

These may also constitute part of the investment logic. $BrightGene(688166.SH)

Source: Pharmaceutical Research Society