GYRE THERAPEUTICS, INC.

Forward-Looking Statements and Market Data

This Annual Report on Form 10-K (this “Annual Report”) and the documents incorporated by reference herein contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements, other than statements of historical facts, included or incorporated by reference in this Annual Report regarding our strategy, future results of operations, future financial condition, future revenues, projected costs, prospects, plans, intentions and objectives of management, as well as the assumptions that underlie these statements, are forward-looking statements. These forward-looking statements should not be relied upon as predictions of future events as we cannot assure you that the events or circumstances reflected in these statements will be achieved or will occur. Forward-looking statements are identified by words such as “believes,” “expects,” “may,” “will,” “should,” “seeks,” “intends,” “plans,” “pro forma,” “estimates,” or “anticipates” or the negative of these words and phrases or other variations of these words and phrases or comparable terminology, although not all forward-looking statements contain these identifying words. Such forward-looking statements are based on our management’s assumptions and assessments in light of information currently available to our management, its experience and its perception of historical trends, current conditions, expected future developments and other factors our management believes to be appropriate.

You should read these statements carefully because they discuss future expectations, contain projections of future results of operations or financial condition, or state other “forward-looking” information. These statements relate to our plans, objectives, expectations, intentions and financial performance and the assumptions that underlie these statements. For example, forward-looking statements include any statements regarding:

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our ability to conduct extensive clinical trials to demonstrate safety and efficacy of our product candidates;

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our ability to develop a pipeline of product candidates to address unmet needs in the treatment of organ fibrosis and other inflammatory diseases;

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the timing, progress and results of clinical trials for: (i) F351 (Hydronidone) from the Phase 3 clinical trial in the People’s Republic of China (the “PRC”) for the treatment of liver fibrosis associated with chronic hepatitis B (“CHB”) and Phase 2 trial in the United States for the treatment of metabolic dysfunction-associated steatohepatitis- (“MASH”) associated liver fibrosis; (ii) ETUARY from the Phase 3 clinical trial for pneumoconiosis; (iii) F573 from the Phase 2 clinical trial in the PRC for the treatment of on-chronic liver failure; and (iv) other product candidates we may develop, including F230 and F528, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the studies or trials will become available and research and development programs;

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the timing, scope and likelihood of U.S., PRC and comparable foreign regulatory filings and approvals, including timing of investigational new drug applications (“INDs”) and final FDA and National Medical Products Administration ("NMPA") approval of F351 for the treatment of liver fibrosis associated with MASH and CHB, respectively, ETUARY for the treatment of pneumoconiosis, F528 for the treatment of chronic obstructive pulmonary disease (“COPD”), F230 for the treatment of pulmonary arterial hypertension (“PAH”), and any other future product candidates;

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our expectations regarding the future pursuit of product development efforts, including whether we will pursue such efforts, estimates regarding the expenses, future revenue, timing of any future revenue, capital requirements and need for additional financing related to such efforts, the timing of and our ability to pursue such efforts and our plans to develop and, if approved, subsequently commercialize any product candidates resulting from such efforts;

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our expectations regarding our ability to fund our operating expenses and capital expenditure requirements with our cash and investments;

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our ability to develop and advance current product candidates and programs into, and successfully complete, clinical studies;

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our manufacturing, commercialization and marketing capabilities and strategy;

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plans relating to commercializing nintedanib and avatrombopag, and our product candidates, if approved, including the geographic areas of focus and sales strategy;

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the need to hire additional personnel and our ability to attract and retain such personnel;

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the size of the market opportunity for our product candidates, including estimates of the number of patients who suffer from the diseases we are targeting;

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expectations regarding the approval and use of our product candidates in combination with other drugs;

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expectations regarding the potential for accelerated approval or other expedited regulatory designation;

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our competitive position and the success of competing therapies that are or may become available;

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estimates of the number of patients that we will enroll in our clinical trials;

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the beneficial characteristics and the potential safety, efficacy and therapeutic effects of our product candidates;

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our ability to obtain and maintain regulatory approval of our product candidates and our expectations regarding particular lines of therapy;

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plans relating to the further development of our product candidates, including additional indications we may pursue;

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existing regulations and regulatory developments in the PRC, the United States, Europe, and other jurisdictions;

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our intellectual property position, including the scope of protection we are able to establish and maintain for intellectual property rights covering ETUARY, nintedanib, avatrombopag, F351, F573, F528, and F230, and other product candidates we may develop, including the extensions of existing patent terms where available, the validity of intellectual property rights held by third parties and our ability not to infringe, misappropriate or otherwise violate any third-party intellectual property rights;

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our continued reliance on third parties to conduct additional clinical trials of our product candidates and for the manufacture of our product candidates for clinical trials;

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our relationships with patient advocacy groups, key opinion leaders, regulators, the research community and payors;

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our ability to obtain and negotiate favorable terms of, any collaboration, licensing or other arrangements that may be necessary or desirable to develop, manufacture or commercialize our product candidates;

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the pricing and reimbursement of ETUARY, nintedanib, avatrombopag, F351, F573, F528, and F230, and other product candidates we may develop, if approved;

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the rate and degree of market acceptance and clinical utility of F351, and other product candidates we may develop;

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our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;

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our financial performance;

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the period over which we estimate our existing cash will be sufficient to fund our planned operating expenses and capital expenditure requirements;

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expectations about the continued listing of our common stock on The Nasdaq Capital Market; and

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the impact of laws and regulations.

Any such forward-looking statements are not guarantees of future performance and are subject to certain risks and uncertainties that could cause actual results to differ materially from those anticipated in or contemplated by such forward-looking statements. Factors that might cause such a difference include, but are not limited to, the risks and uncertainties described in this Annual Report, including those risks described in Part I, Item 1A, “Risk Factors,” and Part II, Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” as well as others that we may consider immaterial or do not anticipate at this time. The risks and uncertainties described in this Annual Report, including in Part I, Item 1A, “Risk Factors,” and Part II, Item 7, “Management's Discussion and Analysis of Financial Condition and Results of Operations,” are not exclusive and further information concerning our company and our businesses, including factors that potentially could materially affect our operating results or financial condition, may emerge from time to time. All forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. These statements, like all statements in this Annual Report, speak only as of their date, and we undertake no obligation to update or revise these statements considering future developments. We caution investors that our business and financial performance are subject to substantial risks and uncertainties, and you should carefully consider the factors set forth in other reports or documents that we file from time to time with the Securities and Exchange Commission (the “SEC”).

This Annual Report also contains estimates, projections and other information concerning our industry, our business, and the markets for certain drugs, including data regarding the estimated size of those markets, their projected growth rates and the incidence of certain medical conditions. Information that is based on estimates, forecasts, projections or similar methodologies is inherently subject to uncertainties and actual events or circumstances may differ materially from events and circumstances reflected in such information. Unless otherwise expressly stated, we obtained this industry, business, market and other data from reports, research surveys, studies and similar data prepared by third parties, industry, medical and general publications, government data and similar sources. In some cases, we do not expressly refer to the sources from which this data is derived. In that regard, when we refer to one or more sources of this type of data in any paragraph, you should assume that other data of this type appearing in the same paragraph is derived from the same sources, unless otherwise expressly stated or the context otherwise requires.