Betta Pharmaceuticals: Summary of 2026 Semi-Annual Report

Summary of the 2026 Semi-Annual Report of Betta Pharmaceutical Co., Ltd.

Securities code: 300558 Securities abbreviation: Betta Pharmaceuticals Announcement number: 2026-053

Summary of the 2026 Semi-Annual Report of Betta Pharmaceuticals Co., Ltd.

1. Important tips

The summary of this semi-annual report comes from the full text of the semi-annual report. In order to fully understand the company's operating results, financial status and future development plans, investors should go to the China Securities Regulatory Commission's designated media website (www.cninfo.com.cn) to carefully read the full text of the semi-annual report.

All directors have attended the board meeting where this report was considered.

The company plans not to distribute cash dividends, give away bonus shares, or convert public reserve funds into share capital.

2. Basic situation of the company

1. Company profile

Stock abbreviation Betta Pharmaceuticals stock code 300558

Stock Exchange Shenzhen Stock Exchange

Contact and Contact Information Secretary of the Board of Directors Securities Affairs Representative

Name Ding Lieming (acting on behalf of the chairman) Shen Jianhao

Phone 0571-89265665 0571-89265665

Xingzhong Road, Economic and Technological Development Zone, Linping District, Hangzhou Office address, Xingzhong Road, Economic and Technological Development Zone, Linping District, Hangzhou

No. 355 No. 355

Email [email protected] [email protected]

2. Main accounting data and financial indicators

Companies are not required to retroactively adjust or restate prior year accounting data

This reporting period is better than the same period last year. This reporting period is better than the same period last year.

increase or decrease

Operating income (yuan) 1,975,927,792.57 1,731,412,742.27 14.12% Net profit attributable to shareholders of listed companies (yuan) 302,134,274.28 139,897,221.85 115.97% Net profit attributable to shareholders of listed companies, net of non-recurring gains and losses

203,403,701.74 190,623,726.76 6.70% profit (yuan)

Net cash flow generated from operating activities (yuan) 412,339,704.08 444,978,288.21 -7.33% Basic earnings per share (yuan/share) 0.72 0.33 118.18% Diluted earnings per share (yuan/share) 0.71 0.33 115.15% Weighted average return on equity 4.61% 2.53% 2.08%

Summary of the 2026 Semi-Annual Report of Betta Pharmaceutical Co., Ltd.

The end of the reporting period is higher than the end of the reporting period at the end of the previous year.

Increase or decrease at the end of the previous year

Total assets (yuan) 10,299,391,770.42 10,565,646,587.69 -2.52%

Net assets attributable to shareholders of listed companies (yuan) 6,625,836,980.33 6,595,157,402.93 0.47%

3. Number of shareholders and shareholding status of the company

Unit: Share

hold special

Voting rights at the end of the reporting period Voting shares

Total number of ordinary shareholders at the end of the reporting period 49,777 Restored preference shares 0 shareholders Total number of 0 shareholders (if any) Total number (if any)

Yes)

Shareholding status of the top 10 shareholders (excluding shares lent through refinancing)

Holding limited Pledge, mark or freeze Name of shareholder Nature of shareholder Shareholding ratio Number of shares held Sale conditions

Share Status Quantity

Number of shares

Ningbo Kaiming Investment Management Partnership

Domestic non-state-owned legal person 19.03% 80,064,000 0 Pledge 49,408,500 (limited partnership)

Zhejiang Jihe Venture Capital Co., Ltd. Domestic non-state-owned legal person 12.91% 54,324,000 0 Not applicable 0 Hangzhou Terry Xi Chuang Enterprise Management Partnership

Domestic non-state-owned legal persons 6.84% 28,797,061 0 Not applicable 0 Enterprise (limited partnership)

Zhejiang Beicheng Investment Management Partnership

Domestic non-state-owned legal persons 2.36% 9,924,563 0 Not applicable 0 (limited partnership)

Shen Zhu Domestic natural person 1.27% 5,342,536 0 Not applicable 0 China Merchants Bank Co., Ltd.-Xing

Others 1.12% 4,726,565 0 Not applicable 0 Quanherun Hybrid Securities Investment Fund

Bank of Shanghai Co., Ltd.-Bank

Huazhong Securities Innovative Drug Industry Transaction Type Others 0.99% 4,167,160 0 Not applicable 0 Open-ended index securities investment fund

ZHANGHANCHENG Overseas natural person 0.97% 4,075,307 0 Not applicable 0 WANGYINXIANG Overseas natural person 0.82% 3,467,177 0 Not applicable 0 Hong Kong Securities Clearing Company Limited Overseas legal person 0.78% 3,266,676 0 Not applicable 0 (1) As of the end of this reporting period, the company’s actual controller, Mr. Ding Lieming, controls 21.3885% of the company’s shares through Ningbo Kaiming Investment Management Partnership (Limited Partnership) and Zhejiang Beicheng Investment Management Partnership (Limited Partnership), and directly holds 1,024,238 shares (0.2434%) of the company’s shares. Mr. Ding Shizhe (son of Mr. Ding Lieming) directly holds 10,960 shares of the company.

(0.0026%), therefore Mr. Ding Lieming, Kaiming Investment, Beicheng Investment, and Mr. Ding Shizhe are

The company's controlling shareholders and persons acting in concert control a total of 21.6345% of the company's shares. Explanation on the related relationships or concerted actions of the above shareholders (2) The actual controller of Zhejiang Jihe Venture Capital Co., Ltd. and Hangzhou Terry Xichuang Enterprise Management Partnership (Limited Partnership) is Mr. Wang Xuechao.

(3) Except for China Merchants Bank Co., Ltd.-Xingquan Herun Hybrid Securities Investment Fund, Bank of Shanghai Co., Ltd.-Yinhua CSI Innovative Drug Industry Traded Open Index Securities Investment Fund, Shenzhu, and Hong Kong Securities Clearing Company Limited, the other six are all former shareholders of the company. The company does not know whether there are related relationships among shareholders other than the pre-IPO shareholders, nor whether they are persons acting in concert under the "Measures for the Administration of Acquisitions of Listed Companies".

Zhejiang Beicheng Investment Management Partnership (Limited Partnership), except for the top 10 ordinary shareholders who hold ordinary shares through ordinary securities accounts, participate in the margin trading and securities lending business

In addition to 49,363 shares, the securities account description (if any) is also guaranteed through customer credit transactions of CITIC Securities Co., Ltd.

The account holds 9,875,200 shares, with a total of 9,924,563 shares held.

Situation of shareholders holding more than 5% of the shares, the top 10 shareholders and the top 10 shareholders of unrestricted tradable shares participating in the refinancing business and lending shares: Not applicable

The top 10 shareholders and the top 10 shareholders of unrestricted tradable shares have changed from the previous period due to refinancing lending/return: Not applicable

The company does not have differential voting rights arrangements

Summary of the 2026 Semi-Annual Report of Betta Pharmaceutical Co., Ltd.

4. Changes in controlling shareholders or actual controllers

The company's controlling shareholder did not change during the reporting period.

The actual controller of the company did not change during the reporting period.

5. Total number of preferred shareholders of the company and shareholding status of the top 10 preferred shareholders

The company has no preference shareholders’ shareholdings during the reporting period.

6. Bonds existing on the date of approval of the semi-annual report: Not applicable

3. Important matters

In the first half of 2026, the company will adhere to the innovation-driven approach, focus on clinical value, accelerate the development of new drugs, continue to deepen market expansion and globalization, and advance strategic cooperation and ecosystem construction in depth. The "four carriages" will advance hand in hand to ensure the sustainable and stable development of the company. During the reporting period, the company achieved operating income of RMB 1,975,927,800, a year-on-year increase of 14.12%; net profit attributable to shareholders of listed companies was RMB 302,134,300, a year-on-year increase of 115.97%. In the first half of 2026, the company’s key work results are summarized as follows:

(1) Improve the innovation platform and optimize pipeline layout

The company always regards innovation as the core of development and attaches great importance to investment in new drug research and development. In the first half of 2026, the company invested 230.7673 million yuan in R&D, focusing on clinical needs and market potential, and carrying out systematic research on innovative targets and mechanisms. At the same time, during the development process, projects were strictly evaluated from clinical feedback, commercial competition landscape, development risks and other dimensions to ensure a balanced pipeline layout and improve development efficiency. Relying on the four major technology platforms of AI-powered small molecule targeted drug platform, GlueOnX (molecular glue platform), DegradoX (targeted protein degrader platform) and AlbuVive (albumin therapy platform), effective R&D investment is gradually being transformed into phased results, promoting the continued growth of the company's pipeline.

BPI-572270 is a new pan-RAS "non-degradable molecular glue" inhibitor independently developed based on the GlueOnX platform. Preclinical studies have shown that it has two major advantages: first, it has stronger inhibitory activity, with the average inhibitory activity in a variety of KRAS mutated tumor cells being about three times that of the reference compound; second, it has better pharmacokinetic properties, good oral absorption, and a longer half-life. With these two advantages, in preclinical animal tumor models, BPI-572270 only needs about 1/10 of the dosage of the reference compound to achieve significant tumor inhibition effects. In January 2026, the drug clinical trial application for BPI-572270 capsules was approved by the NMPA. The company quickly completed the enrollment of the first subject in the Phase I clinical trial within two days after the approval, reflecting the improvement of the company's research and development efficiency. Currently, the Phase I clinical study of this project is in the dose ramping and dose backfill stages, and the overall progress is going smoothly. The company is stepping up its efforts to promote the project, and plans to expand combination treatment options for more indications.

In addition to the BPI-572270 project that has entered clinical phase I, in the direction of RAS targets, BPI-585771, developed based on the DegradoX platform, is a new multi-KRAS mutation (KRASmulti) targeted protein degradation chimera (PROTAC) molecule. The project is expected to submit an IND application within this year. The company will continue to expand its R&D layout in emerging target areas, pool resources, focus on key projects, and accelerate the implementation of product pipelines.

In February 2026, the Phase I/II clinical study of MCLA-129 for injection combined with ensartinib hydrochloride capsules for the treatment of advanced solid tumors completed the enrollment of the first subject, and the project is progressing smoothly; at the same time, for the clinical development of MCLA-129, the company is expanding to more indications. In July, Icotinib tablets received a clinical trial approval notice for the indication for postoperative adjuvant treatment of high-risk IA2-stage IB patients. This approval is a multi-center, retrospective, observational real-world study, aiming to evaluate the effectiveness and safety of icotinib for the postoperative adjuvant treatment of EGFR sensitive mutation-positive IA2 high-risk stage IB NSCLC, which will provide key registration research evidence for the expanded indications of icotinib.

After completing the adjustment of the management structure of the R&D system in 2025, the integrated and established Betta Research Institute adopts a matrix management structure with the project manager responsibility system as the core; in the new drug project approval process, the company has established project approval standards with internationally competitive "differentiation" and "iterative upgrades" as the core. At the same time, it continues to introduce outstanding scientists and cultivate internal outstanding researchers. It has gradually formed a R&D team structure of "leading scientists + young backbones", and the overall R&D ability has been steadily improved. The company continues to introduce high-level R&D talents. Dr. Huang Weisheng and Dr. Zhang Jie joined the company as vice presidents, further enriching the leadership of the R&D team.

Summary of the 2026 Semi-Annual Report of Betta Pharmaceutical Co., Ltd.

(2) Strengthen academic guidance and achieve steady revenue growth

The company has always adhered to the promotion strategy with academic guidance as the core, and a number of research results have been released to the outside world during the reporting period.

In January 2026, the full text of the prognostic factor analysis of large-sample survival data of icotinib in the treatment of EGFR-mutated advanced non-small cell lung cancer (NSCLC) was published in Translational Lung Cancer Research" (impact factor 3.5); in February 2026, the efficacy and safety study of voronib combined with cardenilimab for the first-line treatment of advanced renal cell carcinoma (RCC) was selected for the 2026 ASCO Genitourinary Tumors Symposium (ASCOGU); in March 2026, ensartinib for the treatment of recurrence/ The research results of refractory ALK-positive lymphoma were presented at the 2026 European Society for Blood and Marrow Transplantation (EBMT) Annual Meeting; in May and July 2026, two typical cases of ensartinib used for ALK-rearranged radioiodine-refractory thyroid cancer, and ALK-positive unresectable locally advanced NSCLC with successful transformation surgery were published. This type of post-market research and exploration of products oriented toward patient needs has accumulated rich evidence-based medical evidence for the real-world application of the products, and has also continued to explore the differentiated therapeutic value of the products.

In July 2026, the study of ensartinib in the postoperative adjuvant treatment of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) in IB-IIIB (T3N2M0) stage was published in full online in the international authoritative medical journal "New England Journal of Medicine" (impact factor: 84.5). The study results show that the 2-year disease-free survival (DFS) rate of ensartinib postoperative adjuvant therapy reaches 86.4%, the hazard ratio (HR) is 0.20, and the risk of recurrence is reduced by 80%, which can significantly reduce the probability of disease recurrence. Currently, the domestic marketing application for ensartinib’s postoperative adjuvant indications is in the review stage.

In the field of product commercialization, the company's team continues to delve into academic promotion and enhance medical professionals' awareness and recognition of the company's products and brands. Relying on the industry's leading innovative drug commercialization team, the company replicates the successful experience of icotinib and creates an original model of "central coordination + vertical provincial operators + horizontal product leaders" to weave multi-product marketing into a mutually empowering network and achieve leapfrog growth of products from 1 to N. With the support of this commercialization system, the market access and sales expansion of the company's products have been accelerated.

Starting from January 1, 2026, the new version of the National Medical Insurance Catalog will be implemented. The company's products Kemena, Bemena, Semena and Fumena will maintain the original medical insurance policy unchanged during the agreement period. Beantin will be simultaneously managed in accordance with the national medical insurance Class B drugs, providing continuous guarantee for the market access and sales of the company's core products during the reporting period. On July 9, 2026, icotinib and trastuzumab continued to be included in the "National Essential Drugs List (2026 Edition)", and bevacizumab was newly added to the list, further solidifying the market access basis for the company's products.

Relying on the high-level evidence-based research results of ensartinib postoperative adjuvant therapy published in top medical journals, the commercialization team has carried out academic pre-planning in an orderly manner, steadily cultivated clinical understanding of postoperative adjuvant therapy, and consolidated differentiated competitive advantages. This breakthrough in evidence-based research has expanded the growth space of Bemena's product life cycle, provided core academic support for subsequent approval of auxiliary indications for marketing, inclusion in expert consensus, hospital access and medical insurance demonstration, and continued to consolidate the company's leading market position in the field of ALK-positive lung cancer.

The distribution of Aofumin is an important implementation result of Betta's innovation ecosystem strategy, which further enriches the company's non-tumor product pipeline. Relying on its mature commercial network and rich operational experience, the company's commercial team actively explores new treatment areas such as liver disease and digestion, improving team efficiency while contributing to revenue growth, achieving efficient collaboration between industrial investment and commercial operations. At the same time, the newly approved product Bezedin during the reporting period is also accelerating terminal conversion, laying a solid foundation for subsequent sales volume expansion.

In addition, in the face of changes in the industry environment, the company continues to strengthen the construction of the compliance system, promote the standardization and transparency of the entire academic promotion process, and embed compliance management into all aspects of business operations to ensure the healthy and sustainable development of the commercialization system.

(3) Expand diversified cooperation and accelerate ecosystem construction

With Betta Pharmaceuticals as the core and Betta Industrial Fund and Betta DreamWorks as the two wings, the company adheres to the concepts of co-construction, sharing, openness and win-win to build an innovation ecosystem. Among them, the pharmaceutical industry fund, as a capital engine, invests in the treatment of diseases such as tumors, autoimmune diseases, organ transplantation and major chronic diseases through diversified models, and transforms investment and incubation companies with development potential into strategic partners. Betta DreamWorks relies on the company's years of accumulated R&D resources and industrialization experience to build a one-stop innovation service platform covering R&D, production, and sales outsourcing services, lowering the threshold and opportunity costs of biopharmaceutical entrepreneurship, and promoting the implementation of partners' innovative results with a mature and replicable empowerment model. At the same time, the company adheres to the combination of "bringing in" and "going out" and continues to introduce high-quality partners around the R&D pipeline and overall strategy. Relying on the expansion of the innovation ecosystem and in-depth strategic cooperation, the company and its partners have established a virtuous cycle of development pattern and systematically created the company's multi-polar growth curve.

During the reporting period, the company completed its strategic investment in Zhixing Pharmaceutical and established in-depth business cooperation with the other party. Relying on the full-cycle empowerment system of the company's innovation ecosystem, the company collaboratively promoted the research and development and application of high-end inhalation preparation pipelines, and completed the development layout in the respiratory field.

Summary of the 2026 Semi-Annual Report of Betta Pharmaceutical Co., Ltd.

In February 2026, the pertuzumab injection (berazetin) developed by the company in cooperation with Borui Biotech was approved by the NMPA for marketing. This product is used to treat early breast cancer and metastatic breast cancer. It can be synergized with trastuzumab Arizol to form a mainstream treatment plan for breast cancer. In April 2026, the company's strategic partner Shengsi Biotechnology's first weekly long-acting recombinant eight-factor FRSW117 submitted a marketing application to the NMPA and was accepted. It is currently in the review stage. The company has the exclusive distribution rights of FRSW117 in China.

(4) Implement local development and continue to advance internationalization

Ensartinib is the first small molecule targeted innovative drug for lung cancer marketed globally led by a Chinese company. It has been approved for marketing in mainland China, Macau, and the United States. The registration review work for European marketing is also progressing smoothly, and the international footprint of the product is continuing to expand. In April 2026, the company's controlled subsidiary Xcovery reached a cooperation with global commercialization service provider Eversana. Eversana will provide integrated commercialization services covering market access, sales team building, commercial operations and other sectors. The two parties will jointly promote the commercial expansion of ensartinib in the US market.

DURAVYU (EYP-1901), an ophthalmic sustained-release preparation of voronib developed by the company in cooperation with EyePoint, continues to advance clinical trials. Two pivotal phase III clinical trials (LUGANO, LUCIA) for the treatment of wet AMD (wAMD) have completed patient enrollment in 2025. In August 2026, the first phase III clinical study LUGANO released data. The results showed that: in the full data set, compared with the labeled indications of 2 mg aflibercept control group, the primary endpoint of change from baseline in best-corrected visual acuity (BCVA) was not met; key secondary endpoints - including good safety features, reduced treatment burden, supplement-free usage rate and anatomical control rate - were all achieved. EyePoint plans to discuss the wAMD data package with the U.S. Food and Drug Administration (FDA) in the first half of 2027, following the availability of LUCIA study results in the fourth quarter of 2026. In March 2026, two global pivotal phase III clinical studies (COMO and CAPRI) of DURAVYU for the treatment of diabetic macular edema (DME) completed the administration of the first patient, and completed patient enrollment at the end of July. Clinical result data are expected to be announced in the fourth quarter of 2027.

(5) Quality and efficiency are simultaneously upgraded to ensure stable production capacity

The company has always adhered to the production management concept of "safe production, ingenious manufacturing", and the entire industrial chain production system maintains stable and efficient operation. It continues to implement the GMP quality control system covering the entire product life cycle, and implements control requirements into the entire process of supply, production, quality control, storage and transportation, etc., and fully ensures the commercialization of multiple innovative drugs and the supply of clinical research drugs for new drug projects under development.

During the reporting period, the company further optimized the production and sales coordination mechanism with the PMC plan as the core, formulated rolling production plans based on sales forecasts, established data statistical models to improve production scheduling accuracy and material turnover efficiency, and achieved a significant increase in domestic preparation production capacity utilization compared with previous years. At the production and operation level, the production batches and output of core products have grown steadily and reached new highs. In terms of improving quality and reducing costs, in the first half of the year, the pass rate of production batches was 100%, and the pass rate of market sampling inspections was 100%. Lean production throughout the life cycle was promoted, and the process was optimized while improving quality, resulting in a steady decline in production costs.

In terms of production capacity layout, the company continues to improve the dual-base collaborative manufacturing pattern. In the first half of 2026, the Shengzhou Industrialization Base has fully completed the joint debugging of production equipment, process verification and phased trial production. The newly added API and solid preparation production lines have fully improved the production capacity and capacity. It can not only meet the mass production needs of many new domestic commercial products, but also undertake overseas production. Export orders for APIs in the market; at the same time, the company simultaneously promotes the optimization of production supporting facilities and the transformation of flexible production lines, which can flexibly adapt to the production switching of drugs of different specifications and dosage forms, and has established sufficient production capacity buffer reserves to match the long-term production needs of medium and long-term new product launches and simultaneous expansion of domestic and foreign markets.

In the first half of 2026, the company comprehensively promoted the "four-horse" coordinated development strategy of independent research and development, marketing, strategic cooperation, and innovation ecosystem, and continued to self-research and introduce differentiated and iterative innovative drugs. Relying on differentiated competitive advantages, medical insurance policy dividends, and a complete and mature commercial network, the market sales scale continued to increase, and the main business income steadily increased.

At the same time, the company continues to improve its operation and management capabilities, insists on improving quality and efficiency, and the overall operating efficiency has steadily improved. Through budget management, bidding management, expense assessment, system control and other mechanisms to reasonably manage period expenses, the period expense rate dropped by 7.62 percentage points year-on-year; the company strengthened dealer management and credit management, expanded sales while actively increasing cash withdrawals; during the reporting period, the net cash flow generated from operating activities was 412.3397 million yuan, confirming the high quality of the company's profits and providing a solid financial guarantee for the company's sustainable development. Affected by the increase in equity investment income, the net profit attributable to shareholders of the listed company was 302.1343 million yuan during the reporting period, a year-on-year increase of 115.97%. The net profit after deducting non-recurring gains and losses was 203.4037 million yuan, a year-on-year increase of 6.70%.

The company disclosed the 2026 semi-annual performance forecast on July 22, 2026. The net profit attributable to shareholders of the listed company is expected to be 307.7738 million yuan to 391.7122 million yuan. The net profit attributable to shareholders of the listed company is expected to be 22874.84 yuan after deducting non-recurring gains and losses.

Summary of the 2026 Semi-Annual Report of Betta Pharmaceutical Co., Ltd.

Ten thousand yuan to 285.9356 million yuan. The actual net profit attributable to shareholders of the listed company for this period was 302.1343 million yuan, a decrease of 1.83% from the lower limit of the performance forecast; the actual net profit attributable to shareholders of the listed company after deducting non-recurring gains and losses was 203.4037 million yuan, a decrease of 11.08% from the lower limit of the performance forecast. The main reason is that after the disclosure of the performance forecast, new situations emerged in the research and development projects of the cooperative units. Therefore, the company re-evaluated the recoverable amount of the relevant asset groups. Based on the principle of prudence, a goodwill impairment provision of RMB 29.9334 million was made for the current period.