Suzhou, August 28, 2023 - Kintor Pharmaceutical Limited (“Kintor Pharma” or “the company”, HKEX: 9939), a clinical-stage biotechnology company developing innovative small molecules and biological therapeutics, today announced its 2023 interim results and released an update on its recent business highlights.

2023 Interim Results Highlights

● Kintor Pharma has steadily advanced the global clinical development, with the dermatology pipeline achieving several milestones.

The company has completed the patient enrollment in the Phase III clinical trial of KX-826 for male androgenetic alopecia (AGA) in China, and the top-line data is expected to be released in the fourth quarter of 2023. The Phase III clinical trial of KX-826 for female AGA in China and the Phase III clinical trial for male AGA in the US/globally are under active preparation.

The company has initiated the long-term safety Phase III clinical trial of KX-826 for AGA and completed the first patient enrollment.

The company has completed the patient enrollment in the Phase II clinical trial of GT20029 for male AGA in China, and the top-line data is expected to be released in the first quarter of 2024.

The data of more than 200 subjects in Phase I clinical trials in both China and the US has demonstrated the good safety of GT20029.

● Kintor Pharma’s research achievements have been presented at reputable academic conferences including AAD, and AACR, which have demonstrated its R&D capabilities.

● Kintor Pharma’s stock has been included in Shanghai-Hong Kong Stock Connect, which makes Kintor Pharma a company included in both Shenzhen-Hong Kong and Shanghai-Hong Kong Stock Connect programs.

● Kintor Pharma has a robust financial performance. As of 30 June 2023, the company had cash and cash equivalents and time deposits of RMB701.9 million.

● Kintor Pharma will hold the 2023 interim results conference call at 10:00-11:00 a.m. on 29 August 2023, Beijing time.

Steady Advancement in Global Clinical Development and Good Performance of the Dermatology Pipeline

As a Biotech company focusing on the R&D and industrialization of potential First-in-Class and Best-in-Class innovative drugs, Kintor Pharma has developed a diversified product pipeline including small-molecule drugs, biological innovative drugs, and combination therapies. At present, the company has seven novel drug candidates with First-in-Class or Best-in-Class potential in Phase I-III clinical stages in China and around the world. In the first half of 2023, the company promoted the global clinical development of the product pipeline, especially the dermatology pipeline which has reached several important milestones.

KX-826 is a topical androgen receptor (AR) antagonist that is under clinical development for the potential treatment of AGA and acne. KX-826 is the world's first AR antagonist for AGA treatment which entered the Phase III clinical trial stage.

On 19 July 2023, the company announced the completion of the first patient enrollment in the long-term safety Phase III trial of KX-826 for the treatment of AGA. The trial was approved to be conducted by China National Medical Products Administration (NMPA) on 18 April 2023.

On 11 May 2023, the company announced the successful completion of the Phase II clinical trial of KX-826 for the treatment of male AGA in the US. The results after 24 weeks of treatment are statistically and clinically meaningful compared to baseline and demonstrate a favorable safety profile of KX-826. The company is preparing for the Phase III clinical trial of KX-826 for male AGA in the US/globally.

On 28 March 2023, the company announced the completion of enrollment of all 740 patients for the Phase III clinical trial of KX-826 for the treatment of male AGA in China. The top-line data is expected to be released in the fourth quarter of 2023.

The company also plans to conduct the Phase III clinical trial for female AGA in China.

On 14 October 2022, the company completed the enrollment of all 160 patients in the Phase II clinical trial of KX-826 in China for the treatment of acne. Recently, we have completed data analysis of the trial. The results showed that the efficacy and safety profile of KX-826 are good. At week 12, all patients who achieved treatment success (according to the 5-point Investigator’s Global Assessments (IGA) Scale, a decrease in IGA score to 0-1 and a decrease of ≥2 levels is defined as success) appeared in the experimental group.

Compared with the placebo group, post hoc analysis of subgroups with baseline noninflammatory lesion count ≥ 30 showed that counts of both noninflammatory and inflammatory lesions in the KX-826 group were significantly improved, and the improvements had persisted until the twelfth week. The improvement effect was initially observed in the second week. The safety profile of KX-826 is good. During the research, most adverse events were mild local skin irritation, and the incidence rate in the KX-826 group was similar to that of the placebo group. There were no adverse events that led to withdrawal from the trial or death.

GT20029 is a topical AR-Proteolysis Targeting Chimera (PROTAC) compound that is under clinical development for the potential treatment of AGA and acne. GT20029 is the world’s first topical PROTAC compound which entered the Phase II clinical stage.

On 22 August 2023, the company completed the enrollment of all 180 patients in the Phase II clinical trial of GT20029 in China for the treatment of male AGA, and the top-line data is expected to be released in the first quarter of 2024.

On 10 February 2023, the company announced the top-line data of the Phase I clinical trial of GT20029 for the treatment of AGA and acne in the US. The results showed that GT20029 demonstrated good safety, tolerability, and pharmacokinetics following topical single ascending dose (SAD) administration in healthy subjects and multiple ascending dose (MAD) administration in subjects with AGA or acne.

GT1708F is a Hedgehog/SMO inhibitor that is under clinical development for the potential treatment of blood cancer and idiopathic pulmonary fibrosis (IPF).

On 8 May 2023, the company announced the successful completion of the Phase I clinical trial of GT1708F for the treatment of hematologic malignancies in China. The results showed that GT1708F had demonstrated a good safety and tolerability profile, and all patients experienced no dose-limiting toxicity (DLT) or drug-related serious adverse events (SAE). Preliminary efficacy was observed starting from 180mg dose level in the dose escalation stage for patients with acute myeloid leukemia (AML) who failed multi-line therapies, and the myeloid blasts decreased by up to 62% compared to the baseline in AML patients.

We are currently exploring GT1708F for the treatment of IPF and preparing for the Phase II clinical trial of GT1708F for the treatment of IPF in China.

In addition, the company’s product pipeline includes Pruxelutamide, GT0486, ALK-1 antibody (GT90001) and GT90008 in the clinical stage, and c-Myc inhibitor, a compound of other targets out of PROTAC platform and ALK-1/VEGF bispecific antibody in the preclinical stage.

Continuously Improving R&D Capabilities and Increasing Presence at Reputable Academic Conferences

In the first half of 2023, Kintor Pharma's research results have been presented at reputable academic conferences, proving the company's innovation ability and its international influence, and further demonstrating the First-in-Class potential of the company's product pipeline.

Pruxelutamide’s Phase I clinical trial for the treatment of metastatic breast cancer(mBC) in China will be presented at ESMO 2023

KX-826's Phase II clinical trials for the treatment of male and female AGA in China, and GT20029's Phase I clinical trials for the treatment of AGA and acne in both China and the US will be presented at EADV 2023

KX-826's Phase II clinical trial for the treatment of female AGA in China was presented at CHRS 2023

KX-826's Phase II clinical trial for the treatment of male AGA in China was presented at CSD 2023

Hedgehog/SMO inhibitor GT1708F for the treatment of Acute Myeloid Leukemia (AML) was presented at AACR 2023

KX-826 and GT20029 for treatment of AGA and acne were presented at AAD 2023

Included in Shanghai-Hong Kong Stock Connect and Improving the Market Influence

The recognition of Kintor Pharma in the capital market continues to increase. In March 2023, Kintor Pharma was selected for the Shanghai-Hong Kong Stock Connect, which makes Kintor Pharma a company included in both Shenzhen-Hong Kong and Shanghai-Hong Kong Stock Connect programs. The inclusion further expands the foundation of the company's mainland investors and continuously improves the liquidity and market influence of the company's stock.

On 24 February 2023, the 10th Top 100 Hong Kong Stocks List was released. Kintor Pharma was selected as one of the top 15 biotechnology stocks in the top 100 Hong Kong stocks for its comprehensive strength in five dimensions: market value, cash, return on listing, R&D investment (R&D), and product pipeline, as well as its achievements and future development potential.

In addition, on 28 June 2023, the 2022 Top 100 Innovative Chinese Biopharmaceutical Enterprises List was released. With its outstanding innovation and R&D capabilities, Kintor Pharma was successfully selected for the list of "Top 30 Innovation Chinese Small Molecule Drug Enterprises in China". The company has been included in the list for three consecutive years, which fully reflects the industry's high recognition of the company's innovation capabilities.

A Robust Financial Performance

Our net loss decreased by RMB306.3 million or 59.1% from RMB518.4 million for the six months ended 30 June 2022 to RMB212.1 million for the six months ended 30 June 2023, which was mainly attributable to the decrease of our Group’s research and development expenses and administrative expenses.

Our R&D costs decreased by RMB296.5 million or 64.3% from RMB461.1 million for the six months ended 30 June 2022 to RMB164.6 million for the six months ended 30 June 2023. Such decreased costs were mainly attributable to the company’s adjustment of core business according to the market environment and financials to continuously advance the clinical trials of core products, such as KX-826 and AR-PROTAC (GT20029) for the treatment of AGA and acne.

The company had cash and cash equivalents and time deposits of RMB701.9 million as of 30 June 2023. In addition, the company had unutilised bank facilities of RMB90.0 million as of 30 June 2023. The company has sufficient cash on hand to support the advancement of the company’s clinical trials and research and development.

Chairman’s Message

Dr. Youzhi Tong, founder, chairman and CEO of Kintor Pharma, commented, “In the first half of 2023, the domestic market showed a recovery as a whole. Facing an environment where opportunities and challenges coexist, the company consolidated its strength to reshape the pipeline focused on dermatology and concurrently promoted in the oncology field. The company’s unique and leading advantages in the dermatology field have been used to steadily advance the clinical development process of products around the world and achieved several milestones.

The company has completed the Phase III clinical trial of KX-826 for treating male AGA in China and initiated the long-term safety Phase III clinical trial of KX-826 for AGA, and the Phase III clinical trial for female AGA in China and US/Global Phase III clinical trial for male AGA is also under preparation. The company has completed the patient enrollment of the GT20029 Phase II clinical trial for male AGA in China. In the capital market, after being included in the Shenzhen-Hong Kong Stock Connect, the company’s stock has also been included in the Shanghai-Hong Kong Stock Connect, further enhancing the stock’s liquidity. In academics, the company’s research results have been presented at reputable academic conferences such as AAD, and AACR, proving the company's innovation ability and international influence.

To look ahead, we will continue to accelerate the development of our products in China and globally through in-house development, co-development, and licensing out, and look forward to releasing the top-line data for KX-826 and GT20029 as soon as possible and expect to accelerate the commercialization process. Since the inception of the company, we have always focused on unmet clinical needs and look forward to bringing more innovative therapeutics to patients and creating more value for our shareholders.”

*For more details, please refer to the 2023 interim results announcement.