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Kintor 2022 Interim Results: Pruxelutamide and KX-826 show positive results, business value has been presented

 

Suzhou, August 29, 2022 – 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 2022 interim results and released an update on its recent business highlights.

 

Dr. Youzhi Tong, founder, chairman and CEO of Kintor Pharma, commented, “Despite the challenging market environment in the first half of 2022, the Company has made rapid progress in multi-regional phase III registrational trials, manufacturing and commercialization preparation of in-house developed novel drug Pruxelutamide. Pruxelutamide, which acts as an effective and safe oral drug for patients with mild, moderate and severe COVID-19, has been granted Emergency Use Authorizations (EUAs) in multiple countries and regions. The second key clinical candidate, KX-826 (Pyrilutamide), is in phase III registrational trial in China and phase II trial in the US. The positive results of its phase II clinical trial of KX-826 for the treatment of male androgenetic alopecia (AGA) in China were presented by one of the leading principal investigators (PIs) at a reputable conference in August. As to the capital market performance, Kintor’s stock has performed with a good trading liquidity and been included in the MSCI China Index since May 2022. With regard to honors and awards, the Company’s Pruxelutamide’s COVID-19 Project was awarded financial support from the Ministry of Science and Technology of China and the Science and Technology Department of Jiangsu Province, in addition to a number of industry honors and awards.

 

Since establishment in 2009, Kintor Pharma has been focusing on solving unmet clinical needs and is committed to development in the research, development and commercialization of innovative therapies. Looking forward, we will continue to accelerate the global clinical trials of our core products and move towards commercialization. Meanwhile, we continue to maximize value for our shareholders.”

 

Pruxelutamide As an Effective Oral Drug on Patients with Mild, Moderate or Severe COVID-19

 

Following the outbreak of COVID-19, Kintor Pharma has been advancing our clinical trials of Pruxelutamide and has found it to be effective on patients with mild, moderate and severe COVID-19.

 

On 6 April 2022, the Company announced the top-line results from the global registrational phase III clinical trial of Pruxelutamide on patients with mild to moderate COVID-19 (N­CT04870606). Pruxelutamide effectively reduced hospitalization/mortality; in particular, for subjects who completed the medication for more than 7 days and middle-and-high-age COVID-19 patients with high risk factors, the protection rate was 100%. Pruxelutamide significantly and continuously reduced the SARS-CoV-2 viral load, and improved COVID-19 related symptoms. Pruxelutamide was well tolerated and side effects were manageable in patients with mild to moderate COVID-19.

 

In May 2022, the Elderly Health Center in Zhongshan Hospital Affiliated to Fudan University commenced the investigator-initiated trial (IIT) of Pruxelutamide for patients with severe or critical conditions who experienced rebound of COVID-19 infections after Paxlovid (ChiCTR2200061250). Study showed that there was no virus detected after 7 to 12 days treatment. We will continue to explore Pruxelutamide’s efficacy and safety for patients with severe or critical conditions, expecially those who experienced rebound of COVID-19 infections after Paxlovid.

 

In addition, the Kintor Pharma R&D team published a research paper in the bioRxiv in June 2022, revealing the mechanism of action of Pruxelutamide in patients with severe COVID-19. The paper demonstrates that Pruxelutamide can reduce the risk of cytokine storm and acute respiratory distress. 

 

In conclusion, Pruxelutamide is not only effective for treatment of mild to moderate COVID-19 patients, but also an effective therapeutic drug for severe COVID-19 patients. In the first half of 2022, Pruxelutamide has also been granted EUA by the Ministry of Health of the state of Sarajevo, Bosnia and Herzegovina and authorisation for use by the Ministry of Health of the Republic of Ghana.

 

As it has been three years since the outbreak of the COVID-19 pandemic, and it becomes clearer that the coronavirus will continue to mutate and sustain for a long time. In this context, effective and safe oral therapies for COVID-19 are critical to overcome the pandemic around the globe.

 

Positive Phase II Clinical Trial Results of KX-826 For Male AGA in China

 

According to the statistics released at the 6th Asian Hair Transplant Conference, which 2 billion people suffer from alopecia worldwide, and China accounting for 250 million, means that an average of 1 in 6 Chinese people suffers from alopecia. Alopecia has become a global “dilemma”. As a well-targeted topical androgen receptor (AR) antagonist, KX-826 has demonstrated a good efficacy and safety profile in phase II clinical trials for the treatment of male androgenetic alopecia (AGA) in China.

 

On August 27, 2022, one of the leading principal investigators of the phase II clinical trial of KX-826 in China, Professor Jianzhong Zhang of Peking University People’s Hospital, presented the positive results of the phase II clinical trial of KX-826 at the 6th Annual Meeting of Chinese Hair Research Society sponsored by the Chinese Society of Dermatology（第六届全国毛发学术会议）.

 

A total of 120 Chinese adult male AGA subjects with a mean age of 35.6 who met Hamilton-Norwood classification (IIIv, IV, V) were enrolled in the phase II clinical trial. They were randomly assigned in a 1:1:1:1 ratio to four treatment groups, KX-826 2.5 mg (0.25% concentration) twice daily (BID); KX-826 5 mg (0.5% concentration) once daily (QD); 5 mg (0.5% concentration) BID; and placebo (QD and BID). The primary endpoint for the Phase II Clinical Trial was the change from baseline in non-vellus Target Area Hair Count (TAHC) TAHC at week 24 in comparison with placebo.

 

The results showed that the KX-826 (0.5%) 5mg BID group demonstrated significant improvement in TAHC as compared with the baseline (increased by 22.73 hairs per cm2; P less than 0.001) and placebo group (increased by 15.34 hairs per cm2; P=0.024) after 24 weeks of treatment. The recommend phase III dose is determined as KX-826 (0.5%) 5mg BID.

 

The overall safety profile of KX-826 was good. No serious adverse event (SAE), adverse drug reaction (ADR), nor death occurred. After 14 days of topical application, the systemic exposure of KX-826 and its metabolites in vivo reached a steady state; the blood concentration of each dose group was very low.

 

The Company is currently accelerating phase III clinical trial in China and phase II clinical trial in the US of KX-826 for the treatment of male AGA, as well as phase II clinical trial in China for female AGA, which has completed enrollment of all 160 patients on 4 March 2022. In addition, the first patient enrollment in the Chinese Phase II clinical trial of KX-826 for acne vulgaris was completed on 24 January 2022.

 

There is a huge amount of unmet clinical needs for both AGA and acne vulgaris. As the first company with an in-house topical PROTAC drug, GT20029, which has entered the clinical stage globally. Kintor Pharma is currently conducting a phase I clinical trial of GT20029 for the treatment of AGA and acne vulgaris in both China and the U.S. All 92 subjects were enrolled and dosed in the China trial between 1 February 2022 and 9 August 2022. We expect to complete the database lock of the China phase I clinical trial and perform data analysis in the fourth quarter of 2022. 

 

Pre-clinical studies have shown that GT20029 could effectively block the AR signaling pathway and its physiological functions by degrading AR proteins, providing local efficacy while reducing systemic drug exposure for better safety by limiting skin penetration.

 

The Company will accelerate the clinical progress of KX-826 and GT20029 to bring more innovative and effective treatment options to the hundreds of millions of people suffering from AGA and acne vulgaris worldwide.

 

Advancing the Diversified Portfolio of Products

 

Kintor Pharma’s products pipeline consists of innovative, small-molecule drugs, biologics, and combination therapies. At present, seven novel drugs with First-in-Class or Best-in-Class potential are in phase I-III clinical stages in China and multiple countires.

 

Since Kintor Pharma obtained an exclusive global license from Pfizer to develop, register, produce and commercialize ALK-1 antibody (GT90001) for the treatment of all oncological indications in early 2018, we have started the research and development of biological drugs. GT90001, as a potential first-in-class innovative drug worldwide, is expected to be used in the treatment of a variety of solid tumors. 

 

According to the phase II clinical results of GT90001 and Nivolumab Combination Therapy in Taiwan, China, previously presented at the 2021 ASCO Gastrointestinal Cancers Symposium,  partial remission (PR) was observed in 8 out of 20 evaluable patients, with an objective remission rate of 40% and a good safety profile.

 

On 2 May 2022, we enrolled and dosed the first patient in the U.S. in its multi-regional phase II clinical trial of ALK-1 antibody and Nivolumab combination therapy for the treatment of advanced HCC. The last patient’s last visit was completed on 7 July 2022, followed by database lock and data analysis.

 

Kintor Pharma Included in MSCI China Index

 

On 13 May 2022, Kintor Pharma’ stock has been included in MSCI China Index. The MSCI series index is a stock index compiled by Morgan Stanley Capital International. It is one of the most influential stock indexes in the world and one of the benchmark indexes most used by international investors.

 

The Company’s stock is also included in the Hong Kong Stock Connect Program, the Hang Seng Composite Index and FTSE Index.

 

Other Updates

 

On 11 January 2022, Kintor Pharma was awarded the “Most Valuable Pharmaceutical and Medical Company”.

 

On 17 January 2022, Kintor Pharma won the “Investor Relations Pioneer Award” of listed companies.

 

On 8 April 2022, Kintor Pharma announced the publication of the mechanism of action of Pruxelutamide for the treatment of COVID-19 and the c-Myc degrader preclinical data at the American Association for Cancer Research (AACR) Annual Meeting, via an E-Poster.

 

On 26 May 2022, Kintor Pharma announced that the Company was approved by the Guangdong Provincial Department of Human Resources and Social Security to establish a Guangdong Provincial Doctoral Workstation.

 

On 14 June 2022, Kintor Pharma announced that its “clinical trial cooperative research and development and overseas application demonstration of the anti-COVID-19 drug” project was selected as one of the “Belt and Road” Innovation Cooperation Projects and was included in the list of proposed projects for special fund supported by the Jiangsu Provincial Department of Science and Technology (Innovation Support Plan for International Science and Technology Cooperation/Hong Kong, Macao, and Taiwan Science and Technology Cooperation).

 

On 4 August 2022, Kintor Pharma was included in the “Top 20 Most Influential Small Molecule Innovative Drug Companies in the 2022 China Biopharmaceutical Industry Value List”.

 

In August 2022, Dr. Lu Qun, Chief technology officer of Kintor Pharma, was selected as the “2022 Gusu Innovation and Entrepreneurship Leading Talent” program.

 

2022 Interim Financial Highlights

 

For the six months ended 30 June 2022, the Company’s research and development expenses were RMB 461.1 million , representing a year-on-year increase of 63.4%, which was mainly attributable to an increase in expenses on clinical trials for Pruxelutamide for the COVID-19 indication and an increase in expenses on materials and consumables used in relation to R&D.

 

As at 30 June 2022, the company had cash on hand, financial assets and amount due from related parties totally RMB 510 million. As at 30 June 2022, we had unutilised bank facilities of RMB 120 million.

 

About Kintor Pharmaceutical Limited

Kintor Pharmaceutical Limited is developing and commercializing a robust pipeline of innovative small molecule and biological therapeutics for androgen-receptor-related disease areas with unmet medical needs, including COVID-19, prostate, breast and liver cancers, alopecia and acne.