Initiation of Zhifei Bio's CA111 Injection Phase I Clinical Trial: Analysis of Competitive Position and Valuation Impact

Based on the information obtained, I will analyze the impact of the initiation of Zhifei Bio’s CA111 Injection Phase I clinical trial.

CA111 Injection, developed by Chongqing Chen’an Biopharmaceutical Co., Ltd., a holding subsidiary of Zhifei Bio (Stock Code: 300122.SZ), officially entered Phase I clinical trials in January 2026[1]. According to the announcement, CA111 Injection is a Class 1 chemical drug (innovative drug), a GLP-1/GIP dual receptor agonist, indicated for the treatment of diabetes and weight management[1][2].

Zhifei Bio holds approximately 85% equity in Chen’an Biotech through its Zhirui Investment platform. Chen’an Biotech focuses on metabolic diseases such as diabetes and obesity, and has formed a relatively complete pipeline layout of GLP-1 drugs and insulin analogs[3][4]:

As a GLP-1/GIP dual receptor agonist, CA111 has synergistic potential compared to single-target GLP-1 drugs. It achieves a dual mechanism of action by activating GIP receptors and GLP-1 receptors, which can exert better hypoglycemic and weight management effects[2].

The global GLP-1 drug market is in a period of rapid growth. According to McKinsey data, approximately 900 million people worldwide meet the clinical diagnosis criteria for obesity. In 2024, the quarterly sales of major GLP-1 drugs exceeded USD 4 billion, and it is expected that 5% of the US population will use GLP-1 drugs by 2030[5][6]. In the Chinese market, the size of the GLP-1 market is expected to exceed RMB 60 billion by 2030[7].

The current global GLP-1 market presents a duopoly pattern:

A major shift occurred in the GLP-1 market competition landscape in 2025: Eli Lilly, relying on the clinical efficacy advantages of tirzepatide, surpassed Novo Nordisk to become the market leader for the first time, and the sales gap between the two core products has narrowed to less than USD 2 billion[5][6]. Novo Nordisk is facing multiple pressures such as lagging efficacy, biosimilar threats, and generic drug competition, and has been forced to adjust its oral preparations and pricing strategies[5].

In the Chinese market, competition between Novo Nordisk and Eli Lilly has extended from hospitals to the outpatient sector. Both parties are actively participating in medical insurance negotiations and laying out retail e-commerce channels[7]. Generic versions of semaglutide developed by domestic pharmaceutical companies such as Sihuan Pharmaceutical, Huadong Medicine, Qilu Pharmaceutical, CSPC Pharmaceutical Group, and Livzon Pharmaceutical have been accepted by the National Medical Products Administration (NMPA)[7].

1. Dual-target Mechanism Innovation
   : As a GLP-1/GIP dual receptor agonist, CA111 theoretically achieves better hypoglycemic and weight management effects compared to single-target drugs, which aligns with the global industry trend of GLP-1 drugs iterating towards multi-targets[2].
2. Broad Indication Coverage
   : It covers both diabetes and weight management indications, which can maximize the target patient population.
3. Pipeline Synergy Effect
   : Zhifei Bio has formed a complete echelon layout from liraglutide, semaglutide to dual-target CA111, enabling differentiated competition and full-cycle patient management.
4. Parent Company Platform Advantages
   : It relies on Zhifei Bio’s R&D, production, and sales capabilities in the biopharmaceutical field, as well as its cooperation experience with international pharmaceutical companies such as Merck.

1. Lagging R&D Progress
   : CA111 has just entered Phase I clinical trials, while global leading products are already in the late patent period or facing generic competition. Zhifei Bio’s mature products such as liraglutide and semaglutide are still under review or in clinical stages[4].
2. Uncertainty of Phase I Clinical Trials
   : Phase I clinical trials mainly evaluate safety and tolerability, and subsequent Phase II/III clinical trials still face a high risk of failure. Innovative drug R&D has a long cycle and high uncertainty.
3. Fierce Market Competition
   : In the GLP-1/GIP dual-target field, products such as Eli Lilly’s Retatrutide are already in a leading position, and late entrants face great market competition pressure.

1. Increased Value of R&D Pipeline
   : CA111’s entry into Phase I clinical trials marks substantial progress in Zhifei Bio’s R&D pipeline in the field of metabolic diseases, enriches the company’s product portfolio in development, and enhances long-term growth expectations.
2. Implementation of “Prevention + Treatment” Strategy
   : This project is an important layout for Zhifei Bio to expand from its core vaccine business to the therapeutic biopharmaceutical field, which is in line with the company’s strategic direction of “preventing and treating diseases”.
3. Recognition of Market Potential
   : The GLP-1 drug market, with a scale of over USD 100 billion, provides broad growth space for the project. Even a small market share will have significant valuation implications.

1. Limited Short-term Contribution to Performance
   : Considering that it usually takes 5-7 years from Phase I clinical trials to product launch, CA111 is unlikely to make a substantial contribution to the company’s performance in the short term.
2. R&D Risk Premium
   : The high failure rate of innovative drug R&D means that this project requires continuous high investment, with risks of R&D failure or clinical effects falling short of expectations.
3. Valuation Pressure Factors
   : Zhifei Bio is currently in a loss-making state (P/E ratio: -35.91x). Its stock price has fallen by 18% in the past year and 70.87% in the past three years[3]. In the current market environment, the overall valuation of the biopharmaceutical sector is under pressure.

From a valuation perspective, the impact of the initiation of CA111 Injection’s Phase I clinical trials on Zhifei Bio’s valuation is

• Long-term Value
  : If R&D is successful, CA111 is expected to become one of the core products of Zhifei Bio’s therapeutic biopharmaceutical segment, forming synergy with the existing pipeline, enhancing the company’s market competitiveness in the field of metabolic diseases, and improving the overall valuation level.
• Short-term Impact
  : Considering the early-stage nature of Phase I clinical trials and Zhifei Bio’s current revenue structure dominated by agency business (Merck’s vaccine products), this project has limited short-term impact on the company’s valuation. However, the advancement of the project will help the market re-evaluate the company’s innovation capabilities and improve the market’s negative perception of the company’s “agency dependence”.

1. Track the clinical progress of CA111 and other pipelines of Chen’an Biotech, including the review progress of liraglutide’s marketing application and Phase III data of semaglutide.
2. Follow the progress of medical insurance negotiations for domestic GLP-1 drugs and the launch of competing products.
3. Evaluate the volume growth of Zhifei Bio’s self-developed products and their role in improving the revenue structure.

1. R&D Failure Risk
   : The high probability of clinical failure in innovative drug R&D may lead to the inability to recover early-stage investments.
2. Intensified Market Competition
   : Multinational pharmaceutical companies such as Novo Nordisk and Eli Lilly continue to expand in the Chinese market, and domestic generic pharmaceutical companies are accelerating their catch-up, resulting in increasingly fierce market competition.
3. Policy Uncertainty
   : Changes in medical insurance cost control and drug review policies may affect product pricing and volume growth rhythm.
4. Operational Risk
   : The company’s agency business accounts for a relatively high proportion, and there is uncertainty regarding the renewal and performance of agency agreements.

The initiation of Zhifei Bio’s CA111 Injection Phase I clinical trials is an important milestone in the company’s layout in the field of metabolic disease treatment, reflecting the company’s strategic intention to develop towards the integration of “prevention + treatment”. From the perspective of competitive position, the GLP-1/GIP dual-target mechanism has certain differentiated advantages, but it faces fierce competition from leading products. From a valuation perspective, this project has positive implications for the company’s long-term value, but it is difficult to change the company’s fundamental pattern in the short term. Investors should continuously track the clinical progress of the pipeline and changes in the market competition landscape, and carefully evaluate the investment value.

[1] Sina Finance - Zhifei Bio: CA111 Injection Enters Phase I Clinical Trials (https://finance.sina.com.cn/jjxw/2026-01-12/doc-inhfzysr9966012.shtml)

[2] China Securities Journal - Zhifei Bio: CA111 Injection Obtains Clinical Trial Approval for Diabetes and Weight Management (https://www.cnstock.com/commonDetail/522077)

[3] Jinling API - Zhifei Bio Company Profile and Financial Data

[4] 2025 Semi-annual Report of Chongqing Zhifei Biological Products Co., Ltd. (http://static.cninfo.com.cn/finalpage/2025-08-19/1224504160.pdf)

[5] Huxiu - From Capacity Competition to Commercialization Competition: 2026, the Dual Showdown of GLP-1 Weight Loss Drugs (https://m.huxiu.com/article/4824772.html)

[6] McKinsey - What are GLP-1 medications (https://www.mckinsey.com/featured-insights/mckinsey-explainers/what-are-glp-1-medications)

[7] 36Kr - Mid-game Battle of Weight Loss Drug Giants, Domestic GLP-1s “Siege” Semaglutide (https://m.36kr.com/p/3464606517089929)