歌礼制药(1672.HK)2025年度业绩电话会
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会议摘要
The British Silicon Intelligence and New Intelligence cooperation project was recognized, focusing on the M0 target, launching a differentiated oral polypeptide AC36, and strengthening a diversified product line. Gerry Pharmaceuticals 2025 research and development efficiency, small molecule AC30 and polypeptide AAC36 progress significantly, A40D treatment acne innovation, financing 0.9 billion Hong Kong dollars, focusing on metabolic diseases, optimizing gastrointestinal tolerance and long-term weight management, showing strong market competitiveness and investor support.
会议速览
The dialogue focused on the performance of pharmaceutical companies in 2025, emphasizing sufficient cash reserves, research and development efficiency and progress in the product pipeline, especially the development of weight loss products and acne treatments. Looking forward to 2026, the company mentioned capital management, financing progress and cooperation with the world's top investment institutions.
The dialogue detailed the company's global research and development strategy with differentiation as the core for the huge potential of the weight-loss drug market, especially the non-generic competitive environment in the European and American markets. It emphasizes the concept of participating in global competition and aiming at the top three innovative drug research and development in the Olympic Games. It introduces the two major research and development pipelines of small molecules and peptides, especially the quarterly drug delivery scheme under A30, AC small molecules and ultra-long-term platform and the clinical progress of new target TH beta, showing the company's leading layout and technological breakthrough in the field of weight-loss drugs.
The content focuses on major breakthroughs in the field of peptides in 2025 and the latest progress in the small molecule product pipeline. The declaration of oral small molecule insulin agonists, subcutaneous insulin injection therapy once a month, and the small molecule product pipeline for weight loss drugs, including research and development data and clinical trial plans for new drugs such as AC30 and AC47, are mentioned.
The company describes the results of preclinical studies of two small molecule drugs, AAC39 and AC48, and the clinical progress of two polypeptide drugs, AAC36 and AAC35. As an amylin agonist, AAC39 shows efficacy and selectivity comparable to star products; AC48 is in the discovery stage, and the target is a GIP receptor agonist. AAC36 is a long-half-life insulin polypeptide that is expected to be administered once a quarter, while its oral version has a bioavailability of 6%-8%. AAC35 targets GIP, with significantly extended half-life and planned monthly dosing. Several product pipelines are accelerating to the clinical declaration phase, and a number of important milestones are expected during the year.
In 2025, a major breakthrough was made in drug research and development, and the world's first compound preparation and three-target polypeptide were successfully developed to solve the problem of polypeptide stability and achieve long-term treatment once a month or a quarter. At the same time, small molecule lithium number agonist differentiation is selective, bringing innovation to the field of diabetes treatment. In early 2026, nearly HK $0.9 billion financing was completed, with sufficient funds to support follow-up clinical trials.
Discusses the timeline of the planned communication between the AS30 Phase III clinical trial and the FDA, as well as the importance and application prospects of oral small molecule drugs in the market, and emphasizes the potential advantages of oral drugs compared to traditional injectable drugs.
The dialogue elaborated on the competitive landscape of oral small molecule drugs, especially GIP agonists, pointing out that the current market is dominated by three companies, of which Shudi and you are advancing research and development at different stages, while their own company is in a leading position in the field of GIP agonists. The possible combination application prospects of small molecule drugs in the future are discussed, and the potential of compound preparation with A30 is emphasized. At the same time, it is pointed out that oral small molecule drugs may have fewer adverse reactions, but they still face challenges as single drugs.
Future trends of oral small molecule drugs in weight management in 2026 are discussed, emphasizing the balance of weight loss and gastrointestinal tolerance. The market will show diversified demand, with different people's expectations of weight loss ranging from 10% to 30%. Oral small molecule drugs are expected to occupy a significant share of the future market due to their convenience and potential gastrointestinal tolerance advantages, complementing injectable drugs. At the same time, the possibility of once-a-week dosing by improving the molecular architecture was explored, as well as the challenge of gastrointestinal tolerance during this process.
The dialogue focused on the positioning and differentiation of the weight loss drug pipeline, discussed the comparative advantages of peptide drugs and oral small molecule drugs, as well as the impact of half-life, activity and GI adverse reactions on product competitiveness, and emphasized the strategic significance of diversified product lines.
The positive impact of the decline in GLP-1 drug prices on the size of the weight loss market and the changing trend of the difficulty of entering clinical trials in the future are discussed, emphasizing the competitiveness of the product pipeline and the global market expansion strategy.
要点回答
Q:What are the key results achieved by the company in 2025 and what is the outlook for 2026?
A:In 2025, the company has sufficient cash reserves. As of December 31 of that year, the cash on hand is about 1.9 billion yuan. With the financing of nearly 0.9 billion Hong Kong dollars completed in February, the total cash is far more than 2.8 billion yuan, which is enough to support the research and development of phase III, phase I and phase II. Despite the full-year loss of 0.36 billion RMB, the company was able to maintain sustained development considering cash reserves. The R & D cost is about RMB 0.4 billion, and the company believes that it has done a good job in terms of R & D efficiency and efficient use of costs, which is at the forefront of the industry.
Q:How is the company's weight loss product pipeline progressing?
A:The company focused on the weight loss product pipeline and said that the AC50 pipeline is progressing very well. The single airport climbing test has been completed and the multi-airport test is in progress. It is expected that more results will be shared soon. In addition, the company's literal pipeline also has some differentiation and BD prospects, but it is not discussed in detail in this section.
Q:A40D method of this product situation?
A:A40D is a dermatological drug used to treat acne. In December last year, it submitted a new drug listing application to the China Food and Drug Administration, hoping to be approved and listed as soon as possible. The product is the world's first, safe and effective, oral administration, compared to existing therapies such as sodium isovitamin A, has a faster effect and better safety, but also has unexpected benefits, that is, can reduce liver fat, improve the liver condition of acne patients.
Q:What progress has the company made in capital management and financing?
A:Since the beginning of this year, the company has made major breakthroughs in capital management and financing. In February, it successfully completed a round of financing of nearly 0.9 billion Hong Kong dollars, with the world's top biomedical investment institution GIC (Singapore Government Investment) investing 0.1 billion US dollars (about 0.8 billion Hong Kong dollars). This achievement shows that the company is recognized by internationally renowned investors.
Q:How does the company view the weight loss drug market and its development strategy?
A:The company believes that the market for weight-loss drugs is huge. According to the Global Data report, the market size is expected to reach about US $173.5 billion by 2030 or 2032. The European and American markets are particularly large, as there is no generic competition for Meglumin, and generic drugs are not expected to appear until around 2032. In response to this large market, the company has been formulating differentiated research and development strategies since six or seven years ago, and is committed to becoming the top three in the world, with a layout in the fields of small molecules and peptides. On the small molecule side, the company has a leading small molecule research and development pipeline, including A30, which is about to enter Phase III trials, as well as other oral small molecule drugs. In terms of polypeptides, long-acting polypeptide products for monthly subcutaneous injections or quarterly subcutaneous injections have been developed, and progress has been made in the field of oral polypeptides.
Q:In the field of small molecules, what progress and breakthroughs have you made in your product pipeline?
A:We declared RND in April this year. The product pipeline includes GOPA30, which is about to enter Phase III trials, as well as oral selective agonists and GIP agonists. In addition, we have also developed a subcutaneous insulin preparation injected once a month, and a compound preparation of amylin plus GOPGIP injected once a month, and the effect is better than that of tierbotai in animal models. In addition, we have weekly subcutaneous infusions, oral insulin polypeptide, and once-a-day or once-a-month oral formulations. In the field of peptides, we have a highly differentiated product line, especially in 2025 we have achieved a series of major breakthroughs.
Q:What is the performance of AC30 in the small molecule product pipeline of weight loss drugs you mentioned?
A:The data of AC30 in the phase II trial are bright. After 13 weeks, the weight loss reached 7.7%, which is better than that of European drugs, and the gastrointestinal adverse reactions are far lower than that of Ogrin fat once a week. We are currently conducting a phase III study and expect further improvement in gastrointestinal side effects with the change from one week titration to four week titration. In addition, we plan to conduct AAC35GOPGIP phase 2 clinical trials.
Q:What about AC47 and other oral small molecule drugs?
A:AC47 is a new small molecule for the new target TH beta, used in the field of non-alcoholic steatohepatitis and weight loss, which has significant weight loss effect in animal models and reduced gastrointestinal adverse reactions. At the same time, we are developing selective amylin agonist AAC39 and GIP agonist AC48. Among them, AAC39's efficacy and selectivity in preclinical models are comparable to those of the star product amylin polypeptide. It is expected that the clinical trial application program will be submitted to FDA in the third quarter of this year.
Q:What about A1, a proprietary depot formulation?
A:As a small molecule injected subcutaneously, A1 can be injected once a quarter to maintain body weight, and only 400 mg can maintain the effect for up to four months. This is the unique quarterly administration of body weight maintenance therapy on the market at present.
Q:What is the outstanding performance of AAC36 in the polypeptide product pipeline?
A:AAC36 is a long-acting subcutaneous insulin polypeptide with the potential for monthly or quarterly dosing, with a half-life far exceeding that of competing products. In the obese rat experiment, our peptide showed better efficacy. RND is expected to be declared in the second quarter of this year, and phase II clinical trials are expected to begin by the end of this year.
Q:How is it now communicating with the FDA about the AS30 product, and what is the timeline for the initiation of Phase III clinical trials?
A:We expect to submit our Meeting Request to the FDA in April or early May, followed by a Meeting Package approximately 20 days later. It takes about 70 to 75 days from Meeting Request to FDA feedback. Once consensus is reached, we expect to initiate Phase 3 clinical trials in 3Q20.
Q:Can you share more details about the M part of the AC30 product and the oral GIP receptor agonist?
A:Regarding the M fraction, our previously published preclinical data showed a very strong activity and specific bias. As for the oral GIP receptor agonist, this is a very novel molecule. I will provide further information on the current progress of this product and the application prospects of small molecules in the future.
Q:What is Novo Nordisk's view on the prospects of oral small molecules in the weight loss drug market?
A:As a subcutaneous peptide company, Novo Nordisk is expected to be 1/3 occupied by oral drugs in the global weight loss drug market by 2030, which shows that even subcutaneous peptide companies like Novo Nordisk recognize the importance and market potential of oral drugs. Our AC30 is about to enter phase III clinical trials, GLP-1 oral small molecules are also very attractive. In addition, our company's oral small molecule inhibitors are selective and will file for US IND approval in the third quarter of this year.
Q:What is the current competitive landscape for oral small molecules?
A:At present, in the field of oral small molecule one electricity, in addition to our company, there are two companies published patents, respectively, Dishudi and Novo Nordisk. Novo Nordisk, while focusing on subcutaneous injections of peptides, is also emphasizing the importance of oral medications. Therefore, in the competitive landscape of oral small molecule-one electricity, our three companies are all competing. Among them, Shuodi may be in a leading position, and our AC39 is selective and will apply for US IND approval in the third quarter of this year. As for the specific situation of other competitors, due to lack of public information, it is temporarily impossible to elaborate.
Q:What is the competitive landscape for oral GIP agonists?
A:At present, oral GIP agonists are still in their early stages, and our company's drugs are being declared for US IND, which is expected to be in the fourth quarter of this year. Pfizer has a small molecule antagonist of GIP in Phase II clinical trials. The company claims to be in the discovery stage of GIP agonists, but there are no clinical data yet. We believe that GIP agonists are more promising than antagonists, and our AC38 should be the world's leading.
Q:What do you think about the future positioning of small molecules such as M0, including GIP small molecules? What are the challenges of oral small molecule GIP agonists as single drugs in the future and the possible positioning of compound preparations?
A:These oral small molecules can be used as monotherapy or in combination with other drugs such as A30. For example, a small GIP molecule may be advantageous in combination with an insulin compounding formulation. In the future, small molecules like GIP may be more considered in combination with other drugs to achieve better efficacy. Oral small molecule GIP agonist as a single drug treatment has certain challenges, more suitable for A30 and other drugs into a compound preparation. The existing tablet size and technology can support the GIP agonist, insulin small molecule, etc. into a suitable compound preparation, and the bioavailability is good.
Q:What do you think about the point of improvement in weight loss with oral medications in the future and the goals of combination therapy?
A:In the next few years, the industry trend will pay more attention to the balance between weight loss and gastrointestinal adverse reactions. Both are equally important and even gastrointestinal adverse reactions are more critical. Oral administration of small molecule single-target drugs such as GIP agonists can achieve a weight loss effect of about 15% with a single drug, and there is no need to excessively pursue a weight loss of more than 20%. After 2026, investors and the industry should pay more attention to the long-term effects of gastrointestinal tolerance and weight management. Diversified needs will promote the emergence of multiple types of oral drugs in the market, including single drugs and compound preparations in different doses. To meet the needs of different populations.
Q:If a new architecture can maintain effective concentration in humans, but tolerance cannot, how should it be solved?
A:There is a need to change the molecular architecture to improve activity and ensure that the new architecture can achieve better tolerance in the human body. For example, if a new drug can achieve an effect in humans with only 4 mg per day instead of 40 mg, it may be possible to give it once a week while maintaining a relatively good tolerance.
Q:In the cooperative project of Yingsilicon Intelligence, can the new architecture really achieve once-a-week administration and have good tolerance?
A:That new architecture may just be an improvement of Lee's architecture when it was published, done once a day, but not necessarily once a week and well tolerated. There are no examples of once-a-week dosing that can be achieved and well tolerated.
Q:What is the positioning of the M0 target in Emily's pipeline in terms of weight loss? What is the perception of M0 and GLP-1 combination therapy? What is the positioning and expected effect of the company's existing oral products in the field of weight loss?
A:Regarding the positioning of the M0 target in terms of weight reduction, the company believes that it has potential. Regarding the combination treatment of M0 and GLP-1, although some research results did not meet expectations, considering the situation of multiple competitors, it still needs further observation and discussion. The company has two oral products under research. Their positioning in weight loss is to achieve a different distinction from existing drugs, especially in terms of efficacy and tolerance, such as achieving better weight loss through unique design and better gastrointestinal adverse reactions.
Q:Why did the company decide to develop both oral peptides and small molecule insulin?
A:Based on its diversified platform technology, the company can optimize highly active peptide drugs into oral forms once a day or once a week. At the same time, considering the long half-life and long-lasting effect in vivo, as well as good activity and patent protection, the company chose to develop oral peptide and small molecule insulin products at the same time.
Q:What is the impact of price decline on the future market size of weight loss and the difficulty of clinical patient enrollment?
A:Despite the decline in GLP-1 drug prices in the United States, total sales will increase as the number of people taking drugs increases due to the large size of the market and the not yet saturated competitive landscape. In the next three years, the difficulty of patient enrollment is not expected to increase significantly, because the completion time and success rate of clinical trials are highly guaranteed.

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