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Stock code: 688166 Stock abbreviation: Borui Pharmaceutical

The board of directors and all directors of the company guarantee that there are no false records, misleading statements or material omissions in the content of this announcement, and assume legal responsibility for the authenticity, accuracy and completeness of its content in accordance with the law.

Important Content Notes:

The Board of Directors, the Board of Supervisors, the directors, supervisors and senior management of the Company guarantee that the contents of the quarterly report are true, accurate and complete, and that there are no false records, misleading statements or material omissions, and bear individual and joint legal liability.

The person in charge of the company, the person in charge of accounting and the person in charge of the accounting institution (accounting supervisor) shall ensure the truthfulness, accuracy and completeness of the financial information in the quarterly report.

Whether the third quarter financial statements are audited

□Yes √ No

1. Main financial data

(1) Main accounting data and financial indicators

Unit: Yuan Currency: RMB

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Note 1: "The reporting period" refers to the three-month period from the beginning of the quarter to the end of the quarter, the same below.

Note 2: The year-on-year change in operating income in the reporting period was mainly affected by the year-on-year decrease in technology revenue.

Note 3: The year-on-year change in net profit attributable to shareholders of listed companies during the reporting period was mainly due to the company's adherence to the "R&D-driven" strategy and the continuous increase in R&D investment in BGM0504 injections and other products. After calculation, after excluding the impact of R&D expenses of innovative drugs, the net profit attributable to shareholders of listed companies in the reporting period increased by 16.11% year-on-year.

Note 4: R&D investment in the current period is the sum of the expensed R&D expenses and capitalized R&D expenses in the current period.

(2) Non-recurring profit and loss items and amounts

√ Applicable □Not applicable

Unit: Yuan Currency: RMB

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The reasons should be explained for the company to identify the items not listed in the Explanatory Announcement on Information Disclosure of Companies Offering Securities to the Public No. 1-11 Extraordinary Profit and Loss as non-recurring profit and loss items and the amount is significant, and the non-recurring profit and loss items listed in the Explanatory Announcement on Information Disclosure of Companies Offering Securities to the Public No. 1-11 Extraordinary Profit and Loss are defined as recurring profit and loss.

√ Applicable □Not applicable

Unit: Yuan Currency: RMB

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(3) The circumstances and reasons for changes in major accounting data and financial indicators

√ Applicable □Not applicable

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2. Shareholder information

(1) The total number of ordinary shareholders and the number of preferred shareholders whose voting rights have been restored, and the shareholding of the top 10 shareholders

Unit: shares

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Shareholders holding more than 5% of the shares, the top 10 shareholders and the top 10 shareholders of unrestricted tradable shares participate in the lending of shares in the refinancing business

√ Applicable □Not applicable

Unit: shares

　　■

The top 10 shareholders and the top 10 shareholders of unrestricted tradable shares have changed compared with the previous period due to the refinancing of lending/repayment

√ Applicable □Not applicable

Unit: shares

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3. Other reminders

Other important information about the company's operations in the reporting period that investors need to be reminded of

√ Applicable □Not applicable

1. In terms of major R&D projects, the R&D progress of major products as of the disclosure date of this report is as follows

(1) The two indications of BGM0504 injection for weight loss and type 2 diabetes treatment have achieved the expected goals in phase II clinical trials in China, of which the bariatric indication has obtained the ethical approval for phase III clinical trials, and the first subject has been enrolled, and the phase III clinical study needs to be completed in the follow-up, and can only be produced and marketed after being reviewed and approved by the State Food and Drug Administration; The phase III communication for hypoglycemic indications has been replied by the CDE and agreed to carry out phase III clinical trials, and the phase III clinical trial can only be carried out after obtaining the clinical trial ethics approval from the hospital.

(2) The indication for weight loss of BGM0504 injection has been approved for IND in the United States, and the first subject has been enrolled.

(3) Oral BGM0504 is currently in the preclinical research stage.

(4) The BGC0228 for injection has completed the phase I clinical trial.

On the generic drug side, as of the disclosure date of this report, the R&D progress of the main products is as follows:

(1) Budesonide suspension for inhalation has been declared in China.

(2) Tiotropium Odaterol Inhalation Spray has passed the BE test (bioequivalence test), tiotropium bromide inhalation spray has passed the BE test (bioequivalence test), and tiotropium bromide inhalation powder spray has completed the pilot test.

(3) The clinical trial application for salmeterol ticasone inhalation powder aerosol has been approved, and the first subject has been enrolled.

(4) The ferric carboxymaltose injection has completed the BE test (bioequivalence test).

2. In terms of domestic registration, in the third quarter of 2024, salmeterol ticasone inhalation powder mist, gallium [68Ga] PSMA-0057 injection and lutetium [177Lu] PSMA-0057 injection obtained the drug clinical trial approval notice.

In terms of international registration, in the third quarter of 2024, the New Drug Application (IND) for the indication of weight loss for BGM0504 injection was approved in the United States, fondaparinux injection was approved in Indonesia, eribulin mesylate API passed the DMF technical review in the United States and was approved in Japan, and anidulafungin API and fondaparinuxin decane API were approved in India. BGM0504 injection submitted an IND application for hypoglycemic indication to Indonesia, Dabavancin hydrochloride API submitted DMF to Canada, vorcyclosine API and saxagliptin intermediate submitted DMF to the United States, and sugammadex sodium API submitted DMF to Australia.

3. In terms of intellectual property rights, in the third quarter of 2024, the company submitted 10 new domestic patent applications, obtained 9 new domestic patent authorizations, and obtained 1 new foreign patent application. As of the end of September 2024, the company has applied for a total of 490 patents, including 434 invention patents; It has a total of 261 valid patents, including 220 invention patents, and has been deployed in the United States, Japan, Canada, Europe, South Korea and other countries and regions.

4. As of the end of September 2024, the company's construction projects are as follows:

Taixing API and Preparation Production Base (Phase II), (1) has completed the acceptance of all single buildings and fire protection; (2) The trial production has passed the expert signature opinion; (3) The opinions of environmental protection experts have been issued and are being rectified.

Suzhou Inhaler and Other Chemical Preparation Production Base and Biomedical R&D Center Project (Phase I), (1) The structure of plant (1) and plant (2) has been capped, the secondary structure has been completed, and the installation of doors and windows has been completed; The structure of the R&D building, dangerous goods warehouse and sewage station has been capped, and the secondary structure has been completed; In the construction of the foundation column of overhead corridor 1, the overall completion is 5%; The structure of the accident pool has been completed, and the overall completion is 80%; The curtain wall construction is 90% complete; (2) The mechanical and electrical construction of the plant (1) has been completed, and the mechanical and electrical construction of the first, fifth, sixth and seventh floors of the plant (2) has been completed by 90%.

The new project (phase II) of Suzhou inhaler and other chemical preparation production base and biomedical R&D center, the mechanical and electrical installation and commissioning of the soft mist workshop was completed.

In

the construction project of innovative drug preparation and raw material production base (phase I), the enclosure structure of Suzhou preparation production base has been completed, the main mechanical and electrical materials have been entered, and the construction has been completed by 30%; At present, the maintenance structure of Taixing API production base has been completed, and the main mechanical and electrical materials have entered the site.

4. Quarterly financial statements

(1) The type of audit opinion

□ Applicable √ Not applicable

(2) Financial statements

Consolidated balance sheet

September 30, 2024

Preparation unit: Borui Biopharmaceutical (Suzhou) Co., Ltd

Unit: Yuan Currency: RMB Audit Type: Unaudited

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The person in charge of the company: Yuan Jiandong The person in charge of accounting: Zou Yuanlai The person in charge of the accounting institution: Liu Fang

Consolidated income statement

January to September 2024

Preparation unit: Borui Biopharmaceutical (Suzhou) Co., Ltd

Unit: Yuan Currency: RMB Audit Type: Unaudited

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In the event of a business combination under the same control in the current period, the net profit realized by the merged party before the merger was 0 yuan, and the net profit realized by the merged party in the previous period was 0 yuan.

The person in charge of the company: Yuan Jiandong The person in charge of accounting: Zou Yuanlai The person in charge of the accounting institution: Liu Fang

Consolidated Statement of Cash Flows

January to September 2024

Preparation unit: Borui Biopharmaceutical (Suzhou) Co., Ltd

Unit: Yuan Currency: RMB Audit Type: Unaudited

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The person in charge of the company: Yuan Jiandong The person in charge of accounting: Zou Yuanlai The person in charge of the accounting institution: Liu Fang

From 2024 onwards, the first implementation of new accounting standards or interpretations of standards involves adjustments to the financial statements at the beginning of the year in which they were first implemented

□ Applicable √ Not applicable

The announcement is hereby made.

Board of Directors of Borui Biopharmaceutical (Suzhou) Co., Ltd

October 29, 2024