SUZHOU, China, March 26, 2021 /PRNewswire/ — Kintor Pharmaceutical Restricted (inventory code 9939.HK, “Kintor Pharmaceutical” or the “Firm”), a clinical-stage biotechnology firm growing small molecule and organic therapeutics, not too long ago introduced its enterprise highlights and monetary outcomes for the 12 months ended December 31, 2020.
Dr. Youzhi Tong, co-founder, chairman, and CEO of Kintor Pharmaceutical, stated, “In 2020, regardless of the worldwide COVID-19 pandemic and subsequent public well being disaster , the Kintor staff overcame quite a few challenges and continued making breakthroughs in analysis and growth, and progress in medical operations and industrial collaborations. On Could 22, the Firm was formally listed on the primary board of the Hong Kong Inventory Trade, elevating roughly US$240 million, which can assist the Firm’s long-term objectives in growing and commercializing necessary therapeutics for unmet medical wants.
The Firm’s new investigational drug, proxalutamide, has expanded its indication to COVID-19. Medical analysis has discovered that it might be an necessary software in treating COVID-19 sufferers with delicate, average, extreme, and important signs. In an investigator-initiated medical trial in Brazil, outcomes introduced confirmed that amongst sufferers handled with proxalutamide the hospitalization fee of male sufferers with delicate or average signs was diminished by 100%, whereas that of feminine sufferers was diminished by 90%; the mortality fee of severely-ill sufferers was diminished by 92%, reducing the size of keep by 9 days.
As well as, the Firm collected constructive information in a Taiwan-based Part II medical trial of the mix remedy of ALK-1 monoclonal antibody and nivolumab to deal with metastatic hepatocellular carcinoma (HCC). The trial outcomes confirmed an goal response fee (ORR) of 40%. The Part II medical trial of the mix remedy of ALK-1 monoclonal antibody and nivolumab for the second line remedy of HCC has been authorized by the U.S. Meals and Drug Administration(FDA), and we’re within the means of recruiting sufferers.
In 2020, the Firm established partnerships with six firms. We entered into an unique license settlement with the American agency, Gensun for the event and commercialization of the dual-target antibody PD-L1/TGF-β in Larger China. We shall be collaborating within the discipline of monoclonal antibody and bispecific antibody of organic drugs. We additionally reached a collaboration settlement with Alphamab Oncology to collectively promote the medical analysis of ALK-1monoclonal antibody GT90001 mixed with recombinant humanized PD-L1/CTLA-4 bispecific antibody KN046 for the remedy of hepatocellular carcinoma andother tumors globally. In August, Kintor Pharmaceutical opened a Good Manufacturing Plant (GMP).
Within the face of the COVID-19 pandemic, we at Kintor Pharmaceutical, are deeply conscious of the good duties we shoulder. We’re gratified to see that proxalutamide is displaying nice promise in medical trials for the remedy of COVID-19. The Kintor staff has labored on proxalutamide for greater than ten years. On the similar time, I’m happy that we have now obtained this Part III medical trial approval from the FDA. This has been the primary Part III medical trial approval from the FDA since Kintor’s 2009 founding.
Looking forward to 2021, Kintor Pharmaceutical will proceed its efforts to advance the developmentand commercialization of proxalutamide, as a secure and efficient remedy for COVID-19.
Sooner or later, the Firm will speed up the worldwide medical growth of our present product pipeline, proceed to strengthen worldwide and home partnerships, and fulfill our mission of “specializing in the analysis, growth and commercialization of numerous indications with unmet medical wants.” We’ll proceed to work on benefiting extra sufferers and creating long-term worth for shareholders. “
Latest Enterprise Progress Highlights
1. Product Pipeline Progress
At the moment, the corporate has six merchandise in medical growth. A lot of medical trials have made necessary progress:
Proxalutamide (GT0918, AR antagonist), a brand new technology of AR antagonist
COVID-19 (Brazil and U.S.): In July 2020, the Firm signed a medical trial analysis settlement with Utilized Biology, a U.S. firm, to collaborate within the medical analysis of proxalutamide for the remedy of COVID-19 in Brazil. On January 7, 2021, the Firm introduced the ultimate medical analysis outcomes of an investigator-initiated trial of proxalutamide within the remedy of male sufferers with delicate and average COVID-19 infections. The outcomes of the trial demonstrated the short-term use of proxalutamide is secure and may successfully forestall the deterioration of an infection in males from delicate to extreme COVID-19 infections. As well as, hospitalization charges had been diminished by 100%..
On January 10, 2021, information launched by the corporate confirmed that proxalutamide can considerably inhibit the deterioration of feminine sufferers with COVID-19 from delicate to extreme, and scale back the chance of hospitalization by 90%.
On January 28, 2021, the Brazilian Institutional Evaluation Board authorized the medical trial of proxalutamide within the remedy of severely in poor health sufferers with COVID-19 infections and offered assist within the allocation of medical assets to additional develop the remedy.
On March 11, 2021, the Firm introduced the outcomes of a medical research on proxalutamide within the remedy of hospitalized sufferers with COVID-19 infections. The research outcomes confirmed the mortality fee of sufferers handled with proxalutamide was 92% decrease than that of the management group, and the size of hospital keep was shortened by 9 days.
On March 4, 2021, the U.S. Meals and Drug Administration granted proxalutamide a Part III medical trial license for the remedy of sufferers with delicate and average COVID-19 infections in the USA. Enrollment of sufferers will begin in second quarter.
Metastatic castration-resistant prostate most cancers (China): Two Part III medical trials of proxalutamide as a second-line remedy for metastatic castration-resistant prostate most cancers (mCRPC) and a mix of proxalutamide and Abiraterone as a first-line remedy are presently underway in China. In February 2021, the Firm launched the info of the Part II medical trial at American Society of Medical Oncology Genitourinary Cancers Symposium (ASCO GU) in respect of the security and tolerability of Proxalutamide in mCRPC sufferers who had failed commonplace chemotherapy (together with Docetaxel) or had been unable to tolerate or unwilling to obtain commonplace chemotherapy .
The Part III medical trial of proxalutamide monotherapy completed recruiting sufferers on August 4, 2020. We count on to launch outcomes later in 2021.
Metastatic castration-resistant prostate most cancers (U.S.): On July 16, 2020, the Part II medical trial of proxalutamide within the remedy of metastatic castration-resistant prostate accomplished affected person enrollment in the USA. The medical research outcomes confirmed that proxalutamide was usually secure and efficient on mCRPC sufferers progressed after the remedy with present medicine similar to enzalutamide and abiraterone. In February 2021, the Firm introduced the preliminary evaluation of the Part II research at American Society of Medical Oncology Genitourinary Cancers Symposium(ASCO GU) in respect of the security and tolerability of proxalutamide in mCRPC sufferers who had progressed on both abiraterone(Abi) or enzalutamide(Enza).
AR+ metastatic breast most cancers (China): The Firm is presently finishing up an open and multi-centre Part Ic medical trial to guage the security, pharmacokinetic traits and preliminary efficacy of proxalutamide together with exemestane, letrozole and fulvestrant in sufferers with AR+ metastatic breast most cancers.
Anticipated milestones in 2021
We’ll proceed to advance the medical growth of proxalutamide for the remedy of COVID-19 an infection in 2021 .
As well as, we’ll proceed to advance the medical growth and regulatory means of proxalutamide for the remedy of mCRPC as a single agent and together with abiraterone in 2021.
Pyrilutamide (KX-826), AR antagonist forexternal use
Androgenetic alopecia (China): On December 29, 2020, the recruitment of sufferers for the Part II medical trial of pyrilutamide in China was accomplished. On September 17, 2020, the Firm’s utility of latest drug analysis for pyrilutamide gel formulation for the indication of androgenetic alopecia was authorized by the Nationwide Medical Merchandise Administration (NMPA).
Androgenetic alopecia (U.S.): In August 2020, the Firm accomplished the Part Ib medical trial of pyrilutamide within the U.S. The evaluation and analysis of the trial information are in progress.
Zits (China): On September 17, 2020, the Firm’s utility of latest drug analysis for the zits indications of the pyrilutamide gel formulation was authorized by the Nationwide Medical Merchandise Administration (NMPA).
Anticipated milestones in 2021
The corporate expects to finish Part II medical analysis report and launch information of pyrilutamide in China for androgenetic alopecia within the third quarter of 2021.
Within the first half of 2021, information from the Part Ib medical analysis of pyrilutamidein the U.S. for androgenetic alopecia shall be accomplished and launched.
Within the second quarter of 2021, the Firm expects to finish the primary enrollment of Part I medical trials of zits for pyrilutamide in China. The Part I medical trials are anticipated to be accomplished in 2021.
ALK-1 (GT90001), a brand new anti-angiogenesisinhibitor
Metastatic hepatocellular carcinoma (Taiwan): The Firm is finishing up Part II medical trials of ALK-1 monoclonal antibody and nivolumab (PD-1) in Taiwan, China for the remedy for metastatic hepatocellular carcinoma. In January 2021, the Firm introduced the Taiwanese medical trial information of ALK-1 monoclonal antibody and nivolumab mixed with second-line remedy of metastatic hepatocellular carcinoma on the American Society of Medical Oncology Gastrointestinal Cancers Symposium(ASCO GI). The outcomes confirmed the remedy was secure and that 40% of sufferers noticed partial remission.
Metastatic hepatocellular carcinoma (U.S.): On February 11, 2021, FDA authorized GT90001 mixed with nivolumab for the second-line remedy for superior hepatocellular carcinoma within the Part II medical trial. Enrollment of sufferers is presently underway.
Detorsertib (GT0486), PI3K/mTOR signaling pathway inhibitor
Metastatic strong tumor (China): The corporate obtained an IND approval within the PRC in August 2019. A Part I medical trial is presently underway.
Anticipated milestones in 2021
The Part I medical trial of GT20029 in China shall be accomplished in 2021.
GT1708F (Hedgehog/SMOinhibitor), hedgehog sign transduction pathway inhibitor
Leukemia and Basal Cell Carcinoma (China): The corporate obtained China’s IND approval in February 2020.
Basalcell carcinoma (U.S.): In November 2020, the united statesFDA accepted the corporate’s SMO antagonist for medical trials within the remedy of basal cell carcinoma.
Anticipated milestones in 2021
The Part I medical trial of GT1708F for leukemia in China shall be accomplished in 2021.
GT20029, PROTAC-AR degrader
Androgenetic alopecia and zits (China): In February 2021, the IND utility was accepted by the Chinese language Middle for Drug Analysis (CDE) for the remedy of androgenetic alopecia and zits. It’s the world’s first exterior AR degradation agent based mostly on PROTAC expertise.
Anticipated milestones in 2021
The Part I medical trial of GT20029 in China shall be initiated in2021.
Along with the above clinical-stage medicine, the Firm is growing a wide range of pre-clinical-stage medicine, together with c-Myc inhibitors for the remedy of blood most cancers and PD-L1/TGF-β twin goal antibodies for the remedy of assorted strong tumors in addition to different indications.
2. Manufacturing Base
Suzhou: The Firm’s first GMP plant is positioned at No. 20 Songbei Street, Industrial Park, Suzhou, Jiangsu Province. It covers an space of about 20,000 sq. meters. It was put into operation in August 2020 for the industrial manufacturing of proxalutamide and pyrilutamide. In November 2020, the manufacturing facility obtained the”Drug Manufacturing License.”
Pinghu: The manufacturing base for crude drug and preparations in Pinghu, Zhejiang Province, covers an space of 40,000 sq. meters. The design of the challenge has been accomplished, and development is predicted to begin within the third quarter of 2021. The development shall be accomplished earlier than the top of 2022.
3. Industrial Collaboration
Pyrilutamide industrial collaboration:
On 20 June 2020, the Firm and Jingdong Healthcare entered right into a framework settlement pursuant to which the events will embark on in-depth collaboration for thesales and advertising and marketing of pyrilutamide on the net pharmaceutical retail platform JD.com Pharmacy operated by JD Healthcare.
In March 2020, the Firm signed a collaboration settlement with Sinopharm Holding Co., Ltd.,and can perform all-round collaboration in product design, enterprise channel enlargement, terminal companies, and different facets.
Collaboration with Alphamab Oncology
In July 2020, the Firm and Alphamab Oncology reached a collaboration settlement to collectively develop the mix remedy of PD-L1/CTLA-4 bispecific antibody KN046 andALK-1 monoclonal antibody GT90001 in HCC globally.
Collaboration with Gensun, US
In August 2020, the Firm entered into an unique license settlement with an American firm, Gensun Biopharma, for the PD-L1/TGF-β twin goal antibody GS19, Inc. Kintor Pharmaceutical obtained the unique proper to hold out medical growth and commercialization with GS19 within the Larger China area.
Collaboration with MabPlex Worldwide
In September 2020, the corporate signed a strategic collaboration settlement with MabPlex Worldwide Co., Ltd., and the 2 events launched a full vary of collaboration on the event and manufacturing of bio-macromolecule medicine.
Collaboration with Biotheus
In October 2020, the Firm and Biotheus (Zhuhai) Co., Ltd. reached astrategic collaboration settlement on the event of organic medicine.
4. Format of Globalization
*Institution of New Beijing Subsidiary: Medical and Authorities Affairs
*Institution of New Guangdong Subsidiary: Macromolecular R&D and Manufacturing Base
2020 Annual Monetary Efficiency
As of December 31, 2020, the Firm’s analysis and growth prices elevated 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 principle cause for the rise in R&D expenditure is that the Firm continued to extend R&D funding, accelerated the development of a number of medical trials within the product pipeline, elevated R&D and medical working workers, and the expenditure of fairness incentive plans.
As of December 31, 2019, the Firm’s money and money equivalents amounted to RMB 195.5 million in contrast with RMB 1389.0 million as of December 31, 2020, representing a rise of RMB 1193.5 million, which was primarily as a result of IPO fund-raising and financial institution loans.
As of December 31, 2020, the Firm has used RMB 218.5 million of financial institution financing, with RMB 101.0 million left.
About Kintor Prescription drugs
Kintor Prescription drugs is growing and commercializing a strong pipeline of smallmolecule and organic medicine for androgen-receptor-related illness areas with unmet medical wants, together with COVID-19, prostate, breast and liver most cancers, alopecia and zits. For extra info, go to www.kintor.com.cn.
SOURCE Kintor Pharmaceutical Restricted