KINTOR PHARMA

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Kintor Pharma Announces Full-Year 2021 Financial Results and Recent Business Highlights

On March 25, 2022, Beijing time, Kintor Pharmaceutical (Stock Code: 9939.HK), a biopharmaceutical company focused on the R&D and commercialization of potential first-in-class and best-in-class innovative drugs, announced recent business highlights and its annual performance as of December 31, 2021.

Overview of 2021 Performance Highlights

● Revenue achieveda breakthrough from 0 to 1, reaching RMB 34.23 million, derived from the upfront payment for the licensing of proxalutamide's COVID-19 indication.

● Continuous improvementHighGlobal innovation capabilities, two registrational Phase III global multicenter clinical trialsapproved by the US FDA, four clinical-stage innovative drugs expanding international development footprint, acting as the 'pioneer' for Chinese innovative drug companies going global.

● New drug R&D enters the harvest period, with indications for COVID-19, prostate cancer, and external alopecia treatmentsIt is projected thatto submit NDA applications this year and next.

● Completed the first follow-on offering after listing, net proceeds approximately 1.16 billionHong Kong dollar(equivalent to 150 million US dollars).Only 20% of the 18A companies in the market have achieved refinancing after their IPO*.

● PublicThe company's shares have been included inthe Shanghai-Hong Kong Stock Connect and the Hang Seng Composite Indexand other indices, reflecting the capital market’s recognition and expectations of the company's innovative capabilities.

● Commercial production capacity has significantly increased,with current production capacity for Proxalutamide reaching one million doses per month, expected to reach 50 million doses annually by the end of this year.

*Excluding Biotech companies that have been listed for less than six months and do not yet meet the conditions for new stock issuance.

Dr. Tong Youzhi, Founder, Chairman, and Chief Executive Officer of Kintor Pharmaceuticals,stated:2021 was an extraordinary year for Kintor Pharmaceuticals. The COVID-19 pandemic continues to spread globally, but early on during the outbreak, Kintor expanded the use of Proxalutamide to include COVID-19 indications and conducted a series of studies and clinical trials. We are very pleased to see that the drug developed through over a decade of hard work by our team can contribute to fighting the pandemic. We believe that with firm confidence and joint efforts, we will surely overcome these difficult times.

Looking back at the past year, the company achieved important breakthroughs and strong growth in sales revenue, R&D pipeline, production operations, commercial partnerships, and the capital markets. In terms of sales revenue, the company made its first breakthrough, with income primarily coming from upfront payments for the licensing of Proxalutamide’s COVID-19 indication. In product development, the company’s diversified pipeline of small molecule innovative drugs, biologics, and combination therapies is advancing on multiple fronts, with seven new drug projects currently in clinical trials in China, the United States, and other countries, and several preclinical projects underway. In production operations, the company further increased its production capacity reserves and appointed Dr. Lu Qun as Chief Technology Officer (CTO) to accelerate the commercialization of Proxalutamide. In terms of global collaborations, the company formed strategic partnerships with Huayi Taikang, Fosun Pharma, Etana, XtalPi, and Shanghai Pharmaceutical Holdings, and appointed Dr. Han Jiawen as Vice President of Business Development to further strengthen the company's business expansion capabilities. In the capital markets, the company completed a secondary offering in 2021, raising HKD 1.16 billion to provide robust financial support for its development. Additionally, the company’s shares were also included in the Hang Seng Composite Index and the Shanghai-Hong Kong Stock Connect.

Looking ahead to 2022, the company will accelerate the global clinical development progress of its existing product pipeline, especially the three global multi-center Phase III clinical trials of proxalutamide for COVID-19 treatment. We hope that proxalutamide can play an active role in combating the pandemic. Additionally, we are advancing the clinical progress of frodualin for hair loss indications, with the expectation of benefiting the large population suffering from hair loss as soon as possible.continuouslyWe will focus on international/domestic commercial collaborations to enhance innovation-driven growth momentum. Furthermore, we will increase production capacity reserves and actively promote product commercialization.

Since its establishment in 2009, Kintor Pharmaceutical has remained true to its mission of 'focusing on the research, development, and commercialization of indications with significant unmet clinical needs,' and looks forward to bringing more innovative therapies to patients in the future, creating long-term value for shareholders, and achieving sustainable development for the company.

Recent Business Highlights

Pipeline Progress

The company currently has seven products undergoing clinical research, with each pipeline progressing smoothly and several clinical trials achieving significant milestones:

Proxalutamide (GT0918)

A next-generation androgen receptor (AR) antagonist, as well as an ACE2 and TMPRSS2 degrader, currently under clinical development for the treatment of COVID-19, metastatic castration-resistant prostate cancer, and metastatic breast cancer.

COVID-19

◎ Three investigator-initiated clinical trials in Brazil showed: Proxalutamide demonstrated efficacy for both male and female patients with mild to moderate COVID-19.（NCT04446429 and NCT04853134）The efficacy rates were 92% and approximately 90%, respectively, for severe COVID-19 patients（NCT04728802）mortality ratereduce78%。

◎ Actively advancing three global multi-center Phase III clinical trials led by the company for the treatment of COVID-19 with Proxalutamide, including a global multi-center Phase III clinical trial (NCT04870606) for mild to moderate COVID-19 patients conducted in the United States and other countries, and a global multi-center Phase III clinical trial for mild to moderate COVID-19 patients carried out in China, Brazil, the Philippines, and Malaysia（NCT04869228）, as well as a global multi-center Phase III clinical trial (NCT05009732) for critically ill hospitalized COVID-19 patients conducted in the United States, the Philippines, South Africa, and China.

◎ On July 13, 2021, it was announced that Proxalutamide received Emergency Use Authorization (EUA) from the Ministry of Public Health and Social Welfare of Paraguay（MSPBS）, for the treatment of hospitalized COVID-19 patients. Additionally, Proxalutamide received EUA from the Ministry of Health of Sarajevo Canton, Bosnia and Herzegovina ('BiH') in January 2022 for the treatment of hospitalized COVID-19 patients, and was authorized for use by the Ministry of Health of the Republic of Ghana in March 2022.

◎ On December 27, 2021, the results of the Phase III clinical trial of Proxalutamide for the treatment of mild to moderate COVID-19 patients were announced（NCT04870606）The interim analysis results of NCT04870606 did not show statistical significance due to the low number of events. Based on the interim analysis, proxalutamide demonstrated good safety, with no reports of serious adverse events (SAEs) related to the drug.

◎ On February 10, 2022, the global multicenter Phase III clinical trial for proxalutamide in treating mild-to-moderate COVID-19 patients was conducted across multiple countries including China, Brazil, the Philippines, and Malaysia.PucrolumabGlobal multicenter Phase III clinical trial of proxalutamide for the treatment of mild-to-moderate COVID-19 patients（NCT04869228）The first patient in China was enrolled and dosed at Shenzhen Third People's Hospital.

Metastatic castration-resistant prostate cancer

◎ In China, two Phase III clinical trials are underway: one evaluating proxalutamide as a second-line therapy for metastatic castration-resistant prostate cancer (mCRPC), and another evaluating the combination of proxalutamide and abiraterone as a first-line therapy.

◎ In February 2021, the company presented the results of proxalutamide monotherapy in mCRPC at the ASCO GU conference.mCRPCChinese Phase II clinical trial data of mCRPC and the treatment of mCRPC with proxalutamidemCRPCInterim data from the US Phase II clinical trial of proxalutamide in treating mCRPC.

On February 24, 2022, the Chinese Phase III clinical trial of proxalutamide combined with abiraterone as first-line treatment for mCRPC completed enrollment of all 718 subjects.

Data analysis is currently underway for the US Phase II clinical trial of proxalutamide in treating mCRPC.

AR+ metastatic breast cancer

An open-label, multi-center Phase Ic clinical trial is being conducted in China to evaluate the safety, pharmacokinetics, and preliminary efficacy of proxalutamide in combination with exemestane, letrozole, and fulvestrant in patients with AR+ metastatic breast cancer (mBC).Ic periodThe Phase Ic clinical trial completed patient recruitment on August 25, 2021.

Expected milestones

◎ Top-line data from the Phase III clinical trial (NCT04870606) of Proxalutamide for the treatment of mild-to-moderate COVID-19 patients conducted in the United States and other countries is about to be released.

◎ In the second half of 2022, interim analysis data from the global multi-center Phase III clinical trial (NCT04869228) for mild-to-moderate COVID-19 patients conducted in China, Brazil, the Philippines, and Malaysia will be released.

Furultamide (KX-826)

A topical AR antagonist currently under clinical development for male and female androgenetic alopecia (AGA) and acne treatment. Furultamide is the world's first AR antagonist to enter a registrational Phase III clinical trial for AGA treatment.

Androgenetic Alopecia

◎ For male AGA, a Phase III clinical trial is ongoing in China, while a Phase II clinical trial is underway in the United States; for female AGA, a Phase II clinical trial is being conducted in China.

◎ On September 8, 2021, it was announced that the Phase II clinical trial of Furultamide for male AGA in China had met its primary endpoint, showing favorable efficacy and safety.

◎ On December 31, 2021, the first patient was enrolled and dosed in the registrational Phase III clinical trial of Furultamide for male AGA in China.

◎ On February 28, 2022, the first patient was enrolled and dosed in the Phase II clinical trial of Furultamide for male AGA in the United States.

On March 4, 2022, the Phase II clinical trial in China for Furuidarton's treatment of female AGA completed the enrollment of all 160 subjects.

Acne

The first patient was enrolled and dosed in Furuidarton’s Phase I/II clinical trials for acne treatment in China on April 16, 2021, and January 24, 2022, respectively.

Expected milestones

In the first half of 2022, the Phase III clinical trial in China for Furuidarton's treatment of male AGA completed the enrollment of all subjects.

In the first half of 2022, the Phase II clinical trial in China for Furuidarton’s treatment of acne completed the enrollment of all subjects.

In June 2022, the data from the Phase II clinical trial in China for Furuidarton's treatment of male AGA will be presented by principal investigators (PIs) at relevant seminars.

In the fourth quarter of 2022, preliminary data from the Phase II clinical trial in China for Furuidarton's treatment of female AGA will be obtained.

ALK-1 antibody (GT90001)

A novel anti-angiogenic inhibitor under clinical development for the treatment of metastatic hepatocellular carcinoma and advanced or refractory solid tumors. Kintor Pharma obtained the exclusive global license for the ALK-1 antibody across all cancer indications from Pfizer in 2018.

Metastatic hepatocellular carcinoma

◎ A Phase Ib/II clinical trial of ALK-1 antibody in combination with Nivolumab for second-line treatment of metastatic hepatocellular carcinoma (HCC) is currently underway in Taiwan, China. In January 2021, the company presented data from this Phase II clinical trial in Taiwan at ASCO GI, showing an objective response rate of 40% and good safety.

◎ On February 11, 2021, the U.S. FDA approved the Phase II clinical trial of ALK-1 antibody in combination with Nivolumabfor second-line treatmentof HCC.

◎ On October 9, 2021, a clinical trial of ALK-1 antibody (GT90001C) in combination with Nivolumab for the treatment of HCC patients was approved by China’s National Medical Products Administration (NMPA).

Solid tumors

◎ On November 2, 2021, the first patient was enrolled and dosed in a Phase Ib/II clinical trial in Taiwan, China, evaluating ALK-1 antibody in combination with Corning's recombinant humanized PD-L1/CTLA-4 bispecific antibody KN046 for the treatment of advanced or refractory solid tumors.

Expected milestones

◎ In the first half of 2022, the first patient was enrolled and dosed in the U.S. Phase II clinical trial of ALK-1 antibody in combination with Nivolumab for second-line treatment of HCC.

GT20029

Developed based on PROTAC technology, currently undergoing clinical development for the treatment of AGA and acne. GT20029 is the world's first topical PROTAC compound to enter the clinical stage.

Androgenetic alopecia and acne

◎ On July 28, 2021, the first group of subjects in the Phase I clinical trial of GT20029 in China completed enrollment and dosing.

◎ On February 3, 2022, the Phase I clinical trial of GT20029 for the treatment of AGA and acne in the United States completed the enrollment and dosing of the first subject on February 1, 2022 local time.

Expected milestones

◎ In the first half of 2022, the Phase I clinical trial of GT20029 in China will complete the enrollment and dosing of all subjects.

◎ In the second half of 2022, the Phase I clinical trial of GT20029 in the United States will complete the enrollment and dosing of all subjects.

GT90008

A dual-target antibody for PD-L1/TGF-β, currently under clinical development for the treatment of advanced solid tumors.

On October 21, 2021, GT90008 received approval from China's NMPA to initiate clinical trials for the treatment of advanced solid tumors.

Expected Milestones

In the second half of 2022, the first patient was enrolled and dosed in GT90008’s Phase I clinical trial in China.

Ditoxatine (GT0486)

A PI3K/mTOR signaling pathway inhibitor currently under clinical development for the treatment of metastatic solid tumors.

Currently conducting dose escalation in Phase I clinical trials in China.

GT1708F

A hedgehog signaling pathway inhibitor currently under clinical development for the treatment of hematologic malignancies and basal cell carcinoma.

Currently conducting dose escalation in a Phase I clinical trial in China for the treatment of hematologic malignancies.

In addition to the aforementioned drugs in the clinical stage, the company is developing several preclinical drugs, including an ALK-1/VEGF bispecific antibody and a c-Myc inhibitor.

Commercial collaboration

On April 12, 2021, a strategic cooperation agreement was reached with Huayi Taikang to expand the production capacity of Proxalutamide.

On July 15, 2021, an agreement was reached with Fosun Pharma Industry for the commercialization of Proxalutamide in treating COVID-19 in India and 28 African countries. Both parties will cooperate to jointly advance the Emergency Use Authorization (EUA) application, promotion, and sales of Proxalutamide for its COVID-19 indication. According to the terms of the agreement, Fosun Pharma Industry will obtain exclusive registration and commercial sales rights for Proxalutamide in the cooperation region, paying Kintor Pharma no more than RMB 560 million, including an upfront payment, development milestones of approximately RMB 110 million, and commercial milestones not exceeding RMB 450 million. Additionally, Kintor Pharma will receive tiered royalties of no less than 50% of the total profits based on future net sales of Proxalutamide within the cooperation region.

On August 25, 2021, an agreement was reached with Etana regarding the commercialization of Proxalutamide for treating COVID-19 in Indonesia. According to the agreement, Kintor Pharma will receive an upfront payment and milestone payments from Etana. In addition, Kintor Pharma will also benefit economically from the marketing and sales of Proxalutamide in Indonesia.

On September 7, 2021, announced a collaboration with XtalPi aimed at leveraging artificial intelligence (AI) and computational chemistry technologies to assist in the research and development of anti-tumor monoclonal antibody drugs.

On December 16, 2021, held a strategic cooperation signing ceremony with Shanghai Pharmaceuticals Holding.

Production operations

◎Suzhou production base passed the EU QP audit.

◎Tincture and gel production lines were completed, and a drug production license was obtained.

◎ Commercial production capacity reserveFurther enhance, currently with a monthly production capacity of 1 million doses of proxalutamide, expected to reach an annual capacity of 50 million doses by the end of 2022.

◎ In April 2021, the Zhuhai International Health Port R&D base located in Jinwan District, Zhuhai City, Guangdong Province was launched, focusing on cancer immunotherapy and vigorously promoting the clinical R&D, production, and commercialization of biopharmaceuticals.

◎ The active pharmaceutical ingredient (API) and formulation production base project located in Pinghu County, Zhejiang Province, covers approximately 40,000 square meters,with construction expected to begin in the second quarter of 2022.

Capital market performance

◎ On June 2, 2021, completed the first follow-on offering after listing, raising net proceeds of approximately HKD 1.16 billion (equivalent to USD 150 million).

◎ On September 6, 2021, officially included in the Hang Seng Composite Index and Stock Connect, further enhancing the company’s stock liquidity, visibility, and expanding its investor base.

Other Business Highlights

◎ On April 9, 2021, announced the release of the latest preclinical data on proxalutamide for treating COVID-19 and c-Myc inhibitors for blood cancer at the 2021 American Association for Cancer Research (AACR) Annual Meeting via e-poster presentation.

◎ On May 16, 2021, announced the appointment of Dr. Lu Qun as Chief Technology Officer (CTO), mainly responsible for Chemistry, Manufacturing, and Control (CMC), including drug analysis, formulation development, and production; and appointed Dr. Han Jiawen as Vice President of Business Development, primarily responsible for business development-related operations and management.

On October 19, 2021, Sun Chunlan, member of the Political Bureau of the CPC Central Committee and Vice Premier of the State Council, visited the Center for Drug Evaluation of the National Medical Products Administration to learn about clinical trials and review services for COVID-19 drugs. She also chaired a symposium with relevant enterprises and experts to solicit opinions and suggestions on drug research and development. During this period, Dr. Tong participated in the symposium as an entrepreneur representative and introduced the progress of the Phase III clinical trial of proxalutamide for the treatment of COVID-19.

On November 8, 2021, H.E. Djauhari Oratmangun, Indonesian Ambassador to China, Deny Tjahja, Consul General of Indonesia in Shanghai, and Liky Sutikno, Chairman of the Indonesian Chamber of Commerce in China, visited Kintor Pharmaceutical to gain an in-depth understanding of the company’s development situation. Dr. Tong led the management team to receive the delegation.

Full-year financial performance for 2021

During the reporting period, the company's revenue amounted to RMB 34.23 million, derived from the upfront payment for the out-licensing of proxalutamide’s COVID-19 indication.

As of December 31, 2021, the company's R&D costs increased from RMB 328.8 million for the twelve months ended December 31, 2020, to RMB 767.9 million for the twelve months ended December 31, 2021, representing a growth rate of 133.5%. The main reason for the increase in R&D expenditure was the three global multi-center Phase III clinical trials of proxalutamide for the treatment of COVID-19 led by the company during the reporting period.

As of December 31, 2021, the company had cash, cash equivalents, and time deposits amounting to RMB 1.0552 billion, with utilized bank financing of RMB 154.9 million. Additionally, as of December 31, 2021, the company had unused bank financing of RMB 150 million.

About Kintor Pharmaceutical

Kintor Pharmaceutical was founded in 2009, focusing on the research and industrialization of potential 'best-in-class' and 'first-in-class' innovative drugs, aiming to become a leading enterprise in the research, development, and commercialization of innovative therapies. After years of development, the company has centered on androgen receptor (AR)-related diseases and developed a multi-channel product portfolio covering high-incidence cancers globally and other diseases with unmet clinical needs, including COVID-19, prostate cancer, breast cancer, liver cancer, alopecia, and acne. Kintor Pharmaceutical has strategically laid out a diversified pipeline that includes small-molecule innovative drugs, biologic innovative drugs, and combination therapies, with seven products currently undergoing clinical research, such as two androgen receptor (AR) antagonists, an ALK-1 antibody, AR-PROTAC compounds, a PD-L1/TGF-β dual-target antibody, an mTOR kinase-targeted inhibitor, and a Hedgehog inhibitor, as well as preclinical studies of an ALK-1/VEGF bispecific antibody and a c-Myc inhibitor. The company holds over 80 patents granted or applied for worldwide, with multiple projects listed under China’s 12th and 13th Five-Year Plan ‘Major New Drug Creation’ special projects. On May 22, 2020, Kintor Pharmaceutical officially listed on the Main Board of the Hong Kong Stock Exchange Limited, stock code: 9939.HK. Visit the company’s website: www.kintor.com.cn

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