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歌礼制药 (1672.HK) 2025年中期业绩电话会
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会议摘要
Dr. Wu Jingzi, CEO of the pharmaceutical company, revealed during the mid-term conference call that the company has ample cash reserves, reaching 1.83 billion RMB, with a 32.5% decrease in year-on-year losses in the first half of the year, resulting in a net loss of 88 million RMB. In terms of research and development, the clinical trial results of AC30 oral tablets, AC30 subcutaneous formulations, and AC47 weight loss drugs have been good, with multiple new drug clinical trial applications expected to be submitted in the coming months. The company is currently in deep discussions with multinational pharmaceutical companies for asset licensing, and expects the business deal to be completed in the first half of next year. Dr. Wu is optimistic about the company's future and expresses gratitude for the support of investors.
会议速览
Pharmaceutical company's mid-2025 performance: sufficient cash, reduced losses, significant progress in research and development.
At the mid-term performance reporting meeting in 2025, the pharmaceutical company emphasized its ample cash reserves (1.83 billion RMB) and the significant narrowing of losses in the first half of the year (a 32.5% decrease year-on-year, with a net loss of 0.88 billion RMB). The meeting focused on sharing efficient research and development and operational strategies, as well as the positive progress of the clinical product pipeline, demonstrating the company's confidence in future development.
Clinical advantages and prospects of A30 oral tablets in the field of obesity treatment
The layout of A30 oral tablets in the field of obesity treatment was discussed, emphasizing its independently developed GLPE mechanism and significant weight loss effects demonstrated in the 28-day EBT study completed in the United States. By comparing with existing drugs, it is predicted that A30 oral tablets may achieve a weight loss of 15.4% to 16.4% after 72 weeks of treatment, surpassing current competitors in the market. At the same time, the safety and efficacy data of A30 oral tablets in Phase II clinical trials were shared, pointing out its good safety and tolerability. Detailed results are expected to be announced in the fourth quarter of this year, demonstrating the enormous potential of A30 oral tablets in the field of obesity treatment.
Clinical progress and combined therapy effect of the long-acting weight-loss drugs A30 and AC47.
The dialogue detailed the clinical progress of two long-acting weight loss drugs, A30 and AC47. A30 is administered via monthly subcutaneous injection with a half-life of 36 days, and phase two clinical trials have been initiated. AC47, as a fat-targeted weight loss drug, is used in combination with semaglutide, with animal experiments showing a 55% increase in weight loss. When combined with tirbutide, the effect is even better. It is expected to show similar enhanced effects in obese patients, with the first confirmatory experiment being conducted in the United States. Topline data is expected to be obtained in the first quarter of 2026.
Clinical progress and advantages of self-developed AC50 and AC40 small molecules in the treatment of autoimmune diseases and acne.
The conversation focuses on the clinical progress of the self-developed AC50 oral small molecule in the field of autoimmune diseases, emphasizing its PK advantages, and it is expected to announce single-dose escalation data in the fourth quarter of this year. At the same time, the phase III clinical results of the AC40 small molecule in the treatment of acne are excellent, with significantly better efficacy than existing therapies, and we are looking forward to the NDA application.
Translation: Progress and Future Plans of New Drug Application and Peptide Combination Therapy
The importance of communication with regulatory agencies before applying for new drug approval was discussed, and the preclinical advantages of the combination therapy of self-developed dual-target peptide AC31 and AAC47 were introduced, including significantly better weight loss effects compared to the control group. Emphasis was placed on the pharmacokinetic advantages of AC31 and its differentiation from existing therapies. It was mentioned that 2-3 new drug clinical applications will be submitted to the FDA within the next 6-9 months, involving dual-target and triple-target peptide therapy for obesity. Additionally, it was mentioned that the Phase II clinical progress of the AC30 oral tablet is progressing smoothly, and efficacy data is expected to be released in the fourth quarter, as well as discussions with a chemical company on licensing matters, with expectations for BD cooperation to be finalized in the first half of next year.
Differentiated strategies and future prospects of peptide drug research and development in companies
The conversation centered around the company's differentiated strategy for the development of peptide drugs, detailing the development direction of subcutaneous injection peptides and oral peptides, emphasizing the development of ultra-long-acting drugs platform with a half-life of over 30 days, as well as once-a-week oral peptide products, showcasing the company's unique positioning and confidence in the future pharmaceutical market.
Exploring the advantages of small molecule drugs and licensing strategies.
The questioner first inquired about the advantages of small molecule drugs compared to biologics in terms of bioavailability and side effects, as well as how to determine if long-term use will encounter a weight loss plateau issue. Following that, the questioner discussed whether multinational companies in the BD process are more inclined towards a combination licensing strategy or a single pipeline licensing strategy.
Analysis of the advantages and clinical safety of IS30 oral tablets
Discussed the significant advantages of IS30 oral tablets over competitors in pharmacokinetics, as well as the safety and tolerability demonstrated in clinical trials. Estimated the potential weight loss percentage in future phase III clinical data and mentioned the BD collaboration strategy with global pharmaceutical giants.
ASC30 Phase II Clinical Trial Formulation Selection and Safety Analysis
In the second phase of the ASC30 clinical trial, two different tablet formulations are used to optimize the peak-to-trough concentration ratio, improve the safety and tolerability of the drug. Both formulations achieve high exposure levels, with formulation two further reducing the peak-to-trough ratio to 1.5:1 through proprietary technology, potentially demonstrating better safety and tolerability while maintaining efficacy.
Analysis of differences in drug dosage forms and prediction effects
Discussed the differences between two drug formulations in terms of AUC, peak-trough concentration ratio, and their impact on predicting weight loss. Emphasized the value of thorough exploration in the second phase of the experiment, and mentioned the reasonableness of predicting a weight loss rate of 15.4%-16.4% based on the model, as well as its consistency with reputable analysis reports.
Clinical progress and maintenance treatment strategies of weight-loss drug AAC47.
The weight loss drug AAC47's fat-reducing trend in the human body was discussed, as well as its potential as a maintenance therapy or combination therapy, including its combination use with AC30 and semaglutide, with the goal of achieving weight loss without fat reduction. The company plans to share clinical data on the combination use of AAC47 in the fourth quarter to verify its safety and tolerability.
要点回答
Q:How is the company's business performance in the first half of this year, and what is the situation of its cash reserves? How about the company's loss situation in the first half of this year?
A:As of June 30th this year, the company's cash reserves were approximately 1.83 billion Chinese yuan, enough to support the development of the existing clinical product pipeline. In the first half of this year, the company's net loss was 88 million Chinese yuan, a decrease of 32.5% compared to the same period last year.
Q:What are the research and development progress of AC30 orally disintegrating tablets in the field of obesity? What are the advantages of AC30 orally disintegrating tablets compared to existing weight loss medications?
A:In the field of obesity, research and development of AC30 tablets (GLPE) in the United States showed that a 28-day EBT study demonstrated a significant effect on weight loss with a maintenance dose of 20mg, with a placebo-corrected weight loss of 4.5% to 6.5%. Phase two and phase three trials are expected to show that the efficacy of AC30 tablets may result in a weight loss of 15.4% to 16.4%. According to a report by the renowned American analyst Umalfar, the drug exposure of AC30 tablets is higher than competitors, for example, the steady-state drug exposure of 36mg of offer gay is only 2100. Our data suggests that even at lower doses, AC30 tablets can achieve superior weight loss effects.
Q:How is the safety and efficacy of AC30 oral tablets being evaluated in the ongoing phase II clinical trial in the United States?
A:Currently, in a blinded state, the 13-week Phase II clinical trial of AC30 oral tablets has shown good safety and tolerability, with the low starting dose and slow titration strategy being effective. It is expected that the complete efficacy data will be announced in the fourth quarter of this year.
Q:How is the progress of clinical trials for A30 subcutaneous injection?
A:The A30 subcutaneous injection has started phase II clinical trials in the United States. Due to its ultra-long-acting formulation, with a half-life greater than 30 days, it has good tolerability. The once monthly dosing cycle and 36-day half-life make this product potentially the best in its class for weight loss medication.
Q:As the company's third weight loss drug in the clinical stage, how is the research and development progress of AC47 going?
A:AC47 is a long-acting agonist developed by the u lab research platform of the company for obese patients, with a half-life of 40 days. In preclinical experiments, the efficacy of AC47 was increased by 55% when used in combination with Semaglutide, and all participants have been enrolled. Topline data is expected to be released in the fourth quarter of this year.
Q:How effective is AAC47 in reducing weight when used in combination with other drugs?
A:The combination of AAC47 and Tilbortol in animal experiments showed a better effect on weight loss compared to the combination with Semeriza, demonstrating good potential as a novel targeted weight loss therapy without reducing fat. It can be combined with other marketed or investigational drugs to enhance weight loss effects.
Q:In obese patients, can the combined use of AC47 and Simiplus S17 demonstrate an enhanced weight loss effect?
A:We are very much looking forward to observing in the first confirmatory experiment conducted in the United States whether the weight loss effect of AC47 combined with Simel exceeds that of using 4Me alone, and based on animal experiment data, we anticipate an increase of 55% in effectiveness.
Q:How is the clinical progress of AC50 orally administered small molecule in the field of psoriasis?
A:AC50, an orally administered small molecule targeting the A2 17 receptor, has made smooth progress in clinical trials in psoriasis patients and healthy volunteers in the United States, currently ranking second globally. It holds global intellectual property rights through two independently developed platforms.
Q:What advantages does AC50 oral small molecules have compared to existing drugs in terms of efficacy?
A:AC50 shows excellent PK performance in animal studies, with significantly higher bioavailability and oral exposure compared to similar drug DC853. This indicates that it may become a best in class drug, and data from single dose escalation in healthy volunteers is expected to be released in the fourth quarter of this year, including PK, safety, and efficacy validation.
Q:How are the results of the phase III clinical trial of AC40 oral small molecule therapy for acne?
A:AC40 (generic name geography method) has demonstrated excellent safety and efficacy in Phase III clinical trials, meeting all primary and secondary endpoints. Compared to existing FDA or China NMPA approved oral medications and cream medications, the efficacy of AC40 is significantly superior. It has the potential to become a breakthrough treatment for acne vulgaris, and plans are underway to apply for New Drug Application (NDA) for market approval as soon as possible.
Q:What is the difference in the weight loss effects of using the AC31 dual-target peptide agonist in combination with AC47? What is the development progress and characteristics of AC31 peptide agonist?
A:In a preclinical study using AC31 and AC47 in diet-induced obesity mice, compared to combination of AC47 and Exenatide, the therapeutic effect difference was statistically significant, with a 17.6% enhancement in weight loss. AC31 is a self-developed dual-targeted peptide with excellent pharmacokinetic properties. Its therapeutic effect in preclinical experiments is better than competitors, and it is expected to submit 2 to 3 new RND clinical applications to the US FDA within the next 6 to 9 months for the treatment of obesity.
Q:What are the differences and unique features in the research and development of early injectable and oral peptides?
A:The company has several heavy-weight data to be announced, including the smooth progress of the Phase II of A30 oral tablets, expected efficacy of 15% to 16%. Additionally, the combination therapy of AC47 and 4mei has completed enrollment in the United States, expecting its efficacy to be consistent with animal experiments. At the same time, using the ultra-long-acting drug development platform, the company is developing multiple subcutaneous injection and oral peptide products, planning to submit clinical trial applications to the FDA within the next 6 to 9 months, focusing on the development of triple-target or dual-target peptides for the treatment of obesity.
Q:How to use the Enterprise Live Streaming feature in Enterprise Account?
A:Our company firmly implements a differentiation strategy. For subcutaneous peptide products, we have chosen a version that is injected once a month, while competitors in the market mainly offer products that are injected once a week. Our goal is to achieve differentiation by extending the half-life to over 30 days, and we have already achieved this goal in preclinical experiments. For oral peptides, we also strive for sufficient differentiation. Currently, the oral peptide product we are researching is designed to be injected once a week.
Q:Regarding the clinical research and development progress of the company, especially in the field of small molecule drugs, why is our oral bioavailability high, with obvious advantages in side effects, but are we concerned about hitting a weight loss plateau?
A:Regarding oral small molecule drugs, when we optimize the molecular structure by enhancing activity and improving PK value, the exposure level at steady state of 20 milligrams is significantly better than competitors, and the side effects are relatively small. Currently, phase II clinical trial data shows that during the four-week treatment period, there were no severe adverse reactions such as vomiting, even at higher doses, maintaining good safety and tolerability. Although phase III data has not yet been fully released, based on the existing blind data, we are very confident in our expectations for future weight loss, even if there is a plateau period, we expect to outperform competitors.
Q:In the increasing situation of pipeline platforms, is the company more inclined towards bundled licensing or individual licensing in the BD process?
A:The company maintains flexible communication with the top 12 to 15 pharmaceutical companies globally in BD, providing a combination of product pipelines or individual product licensing according to the different needs of the other party, responding flexibly to market changes and the different expectations of partners.
Q:From the perspective of BD, lately the stock price of Luohe has shown strong performance. How do the world's largest pharmaceutical companies view this situation? How do they plan to respond?
A:In the face of the challenges that the performance of the stock price and related data of Luohe may pose to its market position, the world's largest pharmaceutical company plans to enhance their product pipeline by introducing best in class assets, as independent research and development cannot meet rapid demand. Currently, the most anticipated assets in the market are companies that have entered clinical trials, including your company, our company, Shodhi, and AstraZeneca,,, which have the overground architecture.
Q:周总, the general manager of Dongwu Securities, wants to understand the detailed differences between the two different formulations of tablets in the ASC30 Phase II clinical trial of the company. Are there any differences between these two tablets?
A:These two dosage forms (Dosage form one and Dosage form two) are both once daily, with the characteristic of high exposure levels, both exceeding 3500. The reason for choosing these two dosage forms is that they both can provide higher blood drug concentrations. Among them, the peak-to-trough ratio of Dosage form one is comparable to that of competitors (approximately 2.5:1), while Dosage form two has further improved this ratio through proprietary technology, achieving a ratio of 1.5:1, which may help demonstrate better safety, tolerability, and efficacy in Phase II clinical trials.
Q:Since the difference between the wind concentration and the valley concentration has already been demonstrated, why not directly promote the second model? The difference between the first model and its competitors is not significant, so what is the point of pushing forward with exploration?
A:Advancing the exploration of two formulations is to more finely understand the characteristics of the drug and ensure strong future development. Although the peak concentration to trough concentration ratio of the two formulations is similar to competitors, formulation one has a better AUC tolerability compared to competitors, and formulation two, besides having an AUC exceeding 3500, theoretically has a greater differentiation in the peak concentration to trough concentration ratio. Therefore, conducting a comparison of the two formulations in Phase II clinical trials will help reveal their potential advantages in terms of safety, tolerability, and efficacy.
Q:What assumptions are behind the prediction that the steady state may reach 15.4% to 16.4% in 72 weeks?
A:This prediction is based on analysis of multiple models, considering that the drug's in vitro activity is 2 times higher than its competitors, it is expected to be 3 to 4 percentage points higher than competitors. Internal research believes that due to the drug's activity and unique design, it can perform better on steady-state AOC. In addition, a PPT analysis report by L. Umar was referenced, which is consistent with the company's forecast, and the report will be shared with Mr. Sun after the meeting.
Q:Can Wu Bo briefly introduce the weight loss trend of product 47 on the human body and the strategic considerations for maintaining treatment in the future?
A:Regarding maintenance therapy, the company has two options: one is to use AC 30 subcutaneous injection, taking advantage of its long half-life of up to 35 days to support a dosing interval of one month or longer; the other is to explore AAC47 as a maintenance therapy or in combination with other therapies. AAC47 has a longer half-life (40 days) in obese patients, and may be used alone or in combination with drugs such as telbivudine and IC31 to achieve weight loss without reducing effects. The company is conducting clinical trials and looks forward to sharing data on the weight loss, safety, and tolerability of AAC47 combination therapy in the fourth quarter of this year.
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