(August 23, 2020, Hong Kong) Kintor Pharmaceutical Limited (stock code: 9939.HK, hereinafter referred to as “Kintor Pharmaceutical” or the “Company”) is a clinical-stage novel drug developer in China focused on the proprietary R&D of potential first-in-class and best-in-class drugs for cancers and other indications. The Company was pleased to announce its recent business highlights and the financial results for the six months ended 30 June 2020 (the “Reporting Period”). 

Dr. Youzhi TONG, founder, Chairman and Chief Executive Officer of Kintor Pharmaceutical, indicated that: “In the first half of 2020, all employees of Kintor Pharmaceutical had worked together to overcome difficulties and made breakthroughs in project R&D, clinical operations, listing and financing and commercial cooperation in the context of the novel coronavirus outbreak across the world. On 22 May, the Company was officially listed on the main board of HKEX, with a financing size of approximately US$240 million, representing a debut of the Company in the capital market. The Company obtained the exclusive license for the R&D and commercialization of the dual-targeting antibody PD-L1/TGF-βof Gensun that is a US subsidiary of Zelgen Biopharmaceuticals in the Great China Region this week, which helped Kintor Pharmaceutical realize the in-depth presence in the fields of biological drug monoclonal antibodies and dual antibodies. A Good Manufacturing Practice (GMP) factory of approximately 20,000 sqm is about to be officially put into operation at the end of this month to provide a guarantee for the industrialization of the Company. The Company plans to submit a new drug application for Proxalutamide in Q4, which will be an important milestone for Kintor Pharmaceutical in the way of moving from innovation and R&D to commercialization. In the future, the Company will maintain its R&D advantages, accelerate the global clinical development progress of its existing product pipelines, make the greatest possible efforts to promote the commercialization of Proxalutamide, continuously enhance international/ domestic cooperation, and fulfill the mission of “focusing on the research, development and commercialization of indications with substantial unmet clinical needs”.
 

Product Pipeline Successfully Carry out
 

During the Reporting Period, all product pipelines of the Company run smoothly and some of the clinical trials have obtained key progress.
 

Proxalutamide (GT0918, AR antagonist)
 

mCRPC (China): The Company is conducting the phase III clinical trials of Proxalutamide as the second-line therapy and Proxalutamide combined with Abiraterone as the first-line therapy for mCRPC. As at 4 August 2020, the Company completed patients enrolment for Proxalutamide’s phase III clinical trials for mCRPC and plan to file the NDA application in Q4 of 2020.

mCRPC（the US）： As at 16 July 2020, the Company had completed patients enrolment for Proxalutamide phase II clinical trials in the US. The result of the completed clinical trials showed that Proxalutamide has good safety and efficacy in mCRPC patients progressed after the treatment with existing drugs such as Enzalutamide and Abiraterone.
 

COVID-19 (Brazil): In July 2020, the Company signed a clinical trial study agreement with American company Applied Biology, Inc., under which it will employ Applied Biology to conduct a clinical study on the efficacy of Proxalutamide in the treatment of COVID-19. On 20 August, 2020, the first patient was enrolled.
 

mBC (China): The Company is conducting open, multicentre clinical trials (phase Ic) in China, in order to assess the safety, pharmacodynamics and preliminary efficacy of Proxalutamide combined with Exemestant, Letrozole and Fulvestrant in the treatment of patients with AR+ metastatic breast cancer (mBC).
 

Pyrilutamide (KX-826, AR antagonist for external use)
 

Androgenetic alopecia (China): It’s predicated that the enrolment of the first patient for the phase II clinical trial of Pyrilutamide in China will be completed in Q3 2020.
 

Androgenetic alopecia (the US): In August 2020, the Company completed phase Ib clinical trial of Pyrilutamide in the US and is now analysing and evaluating the trial data. It’s predicated to finalise the CSR report and release the data in Q4 2020.
 

ALK-1(GT90001，ALK-1 humanized monoclonal antibody)
 

HCC (Taiwan): The Company is conducting phase II clinical trials for our ALK-1 monoclonal?antibody as a combination therapy with Nivolumab, a PD-1, for metastatic HCC in Taiwan. It’s predicated to finalise the CSR report and release the data in Q1 2021.
 

Detorsertib (GT0486 mTOR Inhibitor)
 

The Company received the IND approval in China in August 2019 and is expected to commence patient enrolment in Q3 of 2020.
 

GT1708F (Hedgehog／SMO Inhibitor）
 

Leukaemia and BCC (China): The Company obtained IND approval in February 2020 and is expected to commence patients enrolment in Q4 of 2020.
 

BCC (the US) : The Company plans to file the IND application with the U.S. FDA in Q4 of 2020 for GT1708F’s BCC indications
 

In addition to the above drugs at the clinical phase, the Company is also developing several drugs at the preclinical phase, including AR protein degradation agent, c-Myc inhibitor for leukemia, and new-type immunotumor drug IDO inhibitor. Besides, it will introduce its second biologic PD-L1/TGF-β dual-targeting antibody this month.
 

GMP Factory Putting into Operation and Commercialization
 

GMP Factory：The Company's first GMP factory is located at No. 20 Songbei Road, Suzhou Industrial Park, with a site area of approximately 20,000 sqm. It will be put into operation at the end of August this year and it will be mainly used for the commercial production of Proxalutamide and the production of clinical drugs like Pyrilutamide. The factory started to apply for a production license in July this year and planned to realize the GMP compliance in September. It will apply for North American and European GMP certification in the future.
 

Commercialization Cooperation on Pyrilutamide
 

The Company entered into a strategic cooperation framework agreement with JD Healthcare in June 2020 pursuant to which the parties will embark on in-depth collaboration in respect of the sales and marketing of Pyrilutamide on the online pharmaceutical retail platform JD.com Pharmacy (yiyaojd.com) operated by JD Healthcare.
 

The Company entered into a cooperation agreement with Sinopharm Holdings Co., Ltd. in March 2020 pursuant to which the parties will conduct all-round cooperation in product design, business channel expansion, terminal services, etc.
 

Breakthrough in Biological Drugs
 

Introduction of GS19, a new dual-targeting antibody drug of Gensun
 

In August 2020, the Company signed an exclusive license agreement with Gensun Biopharma Inc., a US subsidiary of Zelgen Biopharmaceuticals Co., Ltd., on PD-L1/TGF-βR2 dual-targeting antibody. Kintor Pharmaceutical obtained the exclusive right for the clinical development and commercialization of GS19 in Greater China (including the Chinese mainland, Hong Kong, Macau and Taiwan).
 

Cooperation with Alphamab Oncology
 

In July 2020, the company reached cooperation with Alphamab Oncology to jointly promote the clinical study on ALK-1 monoclonal antibody GT90001 combined with rehumanized PD-L1/CTLA-4 bispecific antibody KN046 in the treatment of hepatocellular carcinoma and other tumors in the world.
 

Financial Results
 

During the Reporting Period, the company’s R&D costs increased by RMB58.9 million or 65.9% from RMB89.4 million for the six months ended 30 June 2019 to RMB148.4 million for the six months ended 30 June 2020. Main reasons for the increase of the R&D cost include continuously increasing R&D input, accelerating the advance of a multiple of clinical trials for product pipeline, expanding the R&D and clinical operation team and expenditure for share incentive plan.
 

As at 30 June 2020, the Company's cash and cash equivalents increased by RMB 15.966 million from RMB1.955 million as at 31 December 2019 to RMB17.922 million. The increase was primarily resulted from the IPO proceeds and bank loans.