On March 26, 2021 Kintor Pharmaceutical Limited (stock code 9939.HK, "Kintor Pharmaceutical" or the "Company"), a clinical-stage biotechnology company developing small molecule and biological therapeutics, reported its business highlights and financial results for the year ended December 31, 2020 (Press release, Suzhou Kintor Pharmaceuticals, MAR 26, 2021, View Source [SID1234577217]).
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Dr. Youzhi Tong, co-founder, chairman, and CEO of Kintor Pharmaceutical, said, "In 2020, despite the global COVID-19 pandemic and subsequent public health crisis , the Kintor team overcame numerous challenges and continued making breakthroughs in research and development, and progress in clinical operations and commercial collaborations. On May 22, the Company was officially listed on the main board of the Hong Kong Stock Exchange, raising approximately US$240 million, which will support the Company’s long-term goals in developing and commercializing important therapeutics for unmet medical needs.
The Company’s new investigational drug, proxalutamide, has expanded its indication to COVID-19. Clinical research has found that it may be an important tool in treating COVID-19 patients with mild, moderate, severe, and critical symptoms. In an investigator-initiated clinical trial in Brazil, results announced showed that among patients treated with proxalutamide the hospitalization rate of male patients with mild or moderate symptoms was reduced by 100%, while that of female patients was reduced by 90%; the mortality rate of severely-ill patients was reduced by 92%, cutting the length of stay by 9 days.
In addition, the Company collected positive data in a Taiwan-based Phase II clinical trial of the combination therapy of ALK-1 monoclonal antibody and nivolumab to treat metastatic hepatocellular carcinoma (HCC). The trial results showed an objective response rate (ORR) of 40%. The Phase II clinical trial of the combination therapy of ALK-1 monoclonal antibody and nivolumab for the second line therapy of HCC has been approved by the U.S. Food and Drug Administration(FDA), and we are in the process of recruiting patients.
In 2020, the Company established partnerships with six companies. We entered into an exclusive license agreement with the American firm, Gensun for the development and commercialization of the dual-target antibody PD-L1/TGF-β in Greater China. We will be collaborating in the field of monoclonal antibody and bispecific antibody of biological medicine. We also reached a collaboration agreement with Alphamab Oncology to jointly promote the clinical research of ALK-1monoclonal antibody GT90001 combined with recombinant humanized PD-L1/CTLA-4 bispecific antibody KN046 for the treatment of hepatocellular carcinoma andother tumors globally. In August, Kintor Pharmaceutical opened a Good Manufacturing Plant (GMP).
In the face of the COVID-19 pandemic, we at Kintor Pharmaceutical, are deeply aware of the great responsibilities we shoulder. We are gratified to see that proxalutamide is showing great promise in clinical trials for the treatment of COVID-19. The Kintor team has worked on proxalutamide for more than ten years. At the same time, I am pleased that we have received this Phase III clinical trial approval from the FDA. This has been the first Phase III clinical trial approval from the FDA since Kintor’s 2009 founding.
Looking ahead to 2021, Kintor Pharmaceutical will continue its efforts to advance the developmentand commercialization of proxalutamide, as a safe and effective treatment for COVID-19.
In the future, the Company will accelerate the global clinical development of our existing product pipeline, continue to strengthen international and domestic partnerships, and fulfill our mission of "focusing on the research, development and commercialization of a large number of indications with unmet clinical needs." We will continue to work on benefiting more patients and creating long-term value for shareholders. "
Recent Business Progress Highlights
1. Product Pipeline Progress
Currently, the company has six products in clinical development. A number of clinical trials have made important progress:
Proxalutamide (GT0918, AR antagonist), a new generation of AR antagonist
COVID-19 (Brazil and U.S.): In July 2020, the Company signed a clinical trial research agreement with Applied Biology, a U.S. company, to collaborate in the clinical research of proxalutamide for the treatment of COVID-19 in Brazil. On January 7, 2021, the Company announced the final clinical research results of an investigator-initiated trial of proxalutamide in the treatment of male patients with mild and moderate COVID-19 infections. The results of the trial demonstrated the short-term use of proxalutamide is safe and can effectively prevent the deterioration of infection in males from mild to severe COVID-19 infections. In addition, hospitalization rates were reduced by 100%..
On January 10, 2021, data released by the company showed that proxalutamide can significantly inhibit the deterioration of female patients with COVID-19 from mild to severe, and reduce the risk of hospitalization by 90%.
On January 28, 2021, the Brazilian Institutional Review Board approved the clinical trial of proxalutamide in the treatment of severely ill patients with COVID-19 infections and provided support in the allocation of medical resources to further develop the treatment.
On March 11, 2021, the Company announced the results of a clinical study on proxalutamide in the treatment of hospitalized patients with COVID-19 infections. The study results showed the mortality rate of patients treated with proxalutamide was 92% lower than that of the control group, and the length of hospital stay was shortened by 9 days.
On March 4, 2021, the U.S. Food and Drug Administration granted proxalutamide a Phase III clinical trial license for the treatment of patients with mild and moderate COVID-19 infections in the United States. Enrollment of patients will start in second quarter.
Metastatic castration-resistant prostate cancer (China): Two Phase III clinical trials of proxalutamide as a second-line therapy for metastatic castration-resistant prostate cancer (mCRPC) and a combination of proxalutamide and Abiraterone as a first-line therapy are currently underway in China. In February 2021, the Company released the data of the Phase II clinical trial at American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO GU) in respect of the safety and tolerability of Proxalutamide in mCRPC patients who had failed standard chemotherapy (including Docetaxel) or were unable to tolerate or unwilling to receive standard chemotherapy .
The Phase III clinical trial of proxalutamide monotherapy finished recruiting patients on August 4, 2020. We expect to release results later in 2021.
Metastatic castration-resistant prostate cancer (U.S.): On July 16, 2020, the Phase II clinical trial of proxalutamide in the treatment of metastatic castration-resistant prostate completed patient enrollment in the United States. The clinical study results showed that proxalutamide was generally safe and effective on mCRPC patients progressed after the treatment with existing drugs such as enzalutamide and abiraterone. In February 2021, the Company announced the preliminary analysis of the Phase II study at American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium(ASCO GU) in respect of the safety and tolerability of proxalutamide in mCRPC patients who had progressed on either abiraterone(Abi) or enzalutamide(Enza).
AR+ metastatic breast cancer (China): The Company is currently carrying out an open and multi-centre Phase Ic clinical trial to evaluate the safety, pharmacokinetic characteristics and initial efficacy of proxalutamide in combination with exemestane, letrozole and fulvestrant in patients with AR+ metastatic breast cancer.
Expected milestones in 2021
We will continue to advance the clinical development of proxalutamide for the treatment of COVID-19 infection in 2021 .
In addition, we will continue to advance the clinical development and regulatory process of proxalutamide for the treatment of mCRPC as a single agent and in combination with abiraterone in 2021.
Pyrilutamide (KX-826), AR antagonist forexternal use
Androgenetic alopecia (China): On December 29, 2020, the recruitment of patients for the Phase II clinical trial of pyrilutamide in China was completed. On September 17, 2020, the Company’s application of new drug research for pyrilutamide gel formulation for the indication of androgenetic alopecia was approved by the National Medical Products Administration (NMPA).
Androgenetic alopecia (U.S.): In August 2020, the Company completed the Phase Ib clinical trial of pyrilutamide in the U.S. The analysis and evaluation of the trial data are in progress.
Acne (China): On September 17, 2020, the Company’s application of new drug research for the acne indications of the pyrilutamide gel formulation was approved by the National Medical Products Administration (NMPA).
Expected milestones in 2021
The company expects to complete Phase II clinical research report and release data of pyrilutamide in China for androgenetic alopecia in the third quarter of 2021.
In the first half of 2021, data from the Phase Ib clinical research of pyrilutamidein the U.S. for androgenetic alopecia will be completed and released.
In the second quarter of 2021, the Company expects to complete the first enrollment of Phase I clinical trials of acne for pyrilutamide in China. The Phase I clinical trials are expected to be completed in 2021.
ALK-1 (GT90001), a new anti-angiogenesisinhibitor
Metastatic hepatocellular carcinoma (Taiwan): The Company is carrying out Phase II clinical trials of ALK-1 monoclonal antibody and nivolumab (PD-1) in Taiwan, China for the treatment for metastatic hepatocellular carcinoma. In January 2021, the Company announced the Taiwanese clinical trial data of ALK-1 monoclonal antibody and nivolumab combined with second-line treatment of metastatic hepatocellular carcinoma at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium(ASCO GI). The results showed the treatment was safe and that 40% of patients observed partial remission.
Metastatic hepatocellular carcinoma (U.S.): On February 11, 2021, FDA approved GT90001 combined with nivolumab for the second-line treatment for advanced hepatocellular carcinoma in the Phase II clinical trial. Enrollment of patients is currently underway.
Detorsertib (GT0486), PI3K/mTOR signaling pathway inhibitor
Metastatic solid tumor (China): The company obtained an IND approval in the PRC in August 2019. A Phase I clinical trial is currently underway.
Expected milestones in 2021
The Phase I clinical trial of GT20029 in China will be completed in 2021.
GT1708F (Hedgehog/SMOinhibitor), hedgehog signal transduction pathway inhibitor
Leukemia and Basal Cell Carcinoma (China): The company obtained China’s IND approval in February 2020.
Basalcell carcinoma (U.S.): In November 2020, the U.S.FDA accepted the company’s SMO antagonist for clinical trials in the treatment of basal cell carcinoma.
Expected milestones in 2021
The Phase I clinical trial of GT1708F for leukemia in China will be completed in 2021.
GT20029, PROTAC-AR degrader
Androgenetic alopecia and acne (China): In February 2021, the IND application was accepted by the Chinese Center for Drug Evaluation (CDE) for the treatment of androgenetic alopecia and acne. It is the world’s first external AR degradation agent based on PROTAC technology.
Expected milestones in 2021
The Phase I clinical trial of GT20029 in China will be initiated in2021.
In addition to the above clinical-stage drugs, the Company is developing a variety of pre-clinical-stage drugs, including c-Myc inhibitors for the treatment of blood cancer and PD-L1/TGF-β dual target antibodies for the treatment of various solid tumors as well as other indications.
2. Production Base
Suzhou: The Company’s first GMP plant is located at No. 20 Songbei Road, Industrial Park, Suzhou, Jiangsu Province. It covers an area of about 20,000 square meters. It was put into operation in August 2020 for the commercial production of proxalutamide and pyrilutamide. In November 2020, the factory obtained the"Drug Manufacturing License."
Pinghu: The production base for crude drug and preparations in Pinghu, Zhejiang Province, covers an area of 40,000 square meters. The design of the project has been completed, and construction is expected to start in the third quarter of 2021. The construction will be completed before the end of 2022.
3. Commercial Collaboration
Pyrilutamide commercial collaboration:
On 20 June 2020, the Company and Jingdong Healthcare entered into a framework agreement pursuant to which the parties will embark on in-depth collaboration for thesales and marketing of pyrilutamide on the online pharmaceutical retail platform JD.com Pharmacy operated by JD Healthcare.
In March 2020, the Company signed a collaboration agreement with Sinopharm Holding Co., Ltd.,and will carry out all-round collaboration in product design, business channel expansion, terminal services, and other aspects.
Collaboration with Alphamab Oncology
In July 2020, the Company and Alphamab Oncology reached a collaboration agreement to jointly develop the combination therapy of PD-L1/CTLA-4 bispecific antibody KN046 andALK-1 monoclonal antibody GT90001 in HCC globally.
Collaboration with Gensun, US
In August 2020, the Company entered into an exclusive license agreement with an American company, Gensun Biopharma, for the PD-L1/TGF-β dual target antibody GS19, Inc. Kintor Pharmaceutical obtained the exclusive right to carry out clinical development and commercialization with GS19 in the Greater China region.
Collaboration with MabPlex International
In September 2020, the company signed a strategic collaboration agreement with MabPlex International Co., Ltd., and the two parties launched a full range of collaboration on the development and production of bio-macromolecule drugs.
Collaboration with Biotheus
In October 2020, the Company and Biotheus (Zhuhai) Co., Ltd. reached astrategic collaboration agreement on the development of biological drugs.
4. Layout of Globalization
*Establishment of New Beijing Subsidiary: Clinical and Government Affairs
*Establishment of New Guangdong Subsidiary: Macromolecular R&D and Production Base
2020 Annual Financial Performance
As of December 31, 2020, the Company’s research and development costs increased by RMB 114.8 million, up 53.6%, from RMB 214 million for the twelve months ended December 31, 2019 to RMB 328.8 million for the twelve months ended December 31, 2020. The main reason for the increase in R&D expenditure is that the Company continued to increase R&D investment, accelerated the advancement of multiple clinical trials in the product pipeline, increased R&D and clinical operating staff, and the expenditure of equity incentive plans.
As of December 31, 2019, the Company’s cash and cash equivalents amounted to RMB 195.5 million compared with RMB 1389.0 million as of December 31, 2020, representing an increase of RMB 1193.5 million, which was mainly due to the IPO fund-raising and bank loans.
As of December 31, 2020, the Company has used RMB 218.5 million of bank financing, with RMB 101.0 million left.