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Industry Overview THIS DOCUMENT IS IN DRAFT FORM, INCOMPLETE AND SUBJECT TO CHANGE AND THE INFORMATION MUST BE READ IN CONJUNCTION WITH THE SECTION HEADED “WARNING” ON THE COVER OF THIS DOCUMENT INDUSTRY OVERVIEW Certain information and statistics set out in this section and elsewhere in this document relating to the industry in which we operate are derived from the Frost & Sullivan Report prepared by Frost & Sullivan, an independent industry consultant we commissioned. We believe that the sources of the information are appropriate sources for such information, and have taken reasonable care in extracting and reproducing such information. We have no reason to believe that such information is false or misleading, or that any fact has been omitted that would render such information false or misleading. The information from official government and non-official sources has not been independently verified by us, the [REDACTED], the [REDACTED], the [REDACTED], the [REDACTED], the Sole Sponsor, any of the [REDACTED], any of their respective directors and advisers, or any other persons or parties involved in the [REDACTED] (save for Frost & Sullivan), and no representation is given as to its accuracy. Accordingly, the official government and non-official sources contained herein may not be accurate and should not be unduly relied upon. PROSTATE CANCER Prostate Cancer and its Treatment Prostate cancer begins when healthy cells in the prostate change and grow out of control, eventually developing into a tumour. The risk factors that may lead to prostate cancer include: mutations in the BRCA1 and/or BRCA2 genes, other genetic changes (HPC1, HPC2, HPCX, CAPB, ATM and FANCA), family history and eating habits. Prostate cancer is one of the ten most common cancer types by the number of new cases in both the United States and globally, while in China, prostate cancer is the 11th most common cancer type in terms of new cases in 2018. The growth rate of prostate cancer from 2014 to 2018 in terms of new cases is the second highest among the ten most common cancer types in China, and is the highest among the ten most common cancer types globally. Prostate cancer is one of the most common cancer types in the male population with over 1.2 million new cases globally in 2018, ranking the second in terms of the number of new cases in male cancer patients. The number of new prostate cancer cases in China reached 102.5 thousand in 2018, ranking the sixth in terms of the number of new cases in male cancer patients. Since the 1940s, endocrine therapy and chemotherapy have been the optimised option for first-line therapies of prostate cancer. According to the latest National Comprehensive Cancer Network (“NCCN”) guidelines for the treatment of prostate cancer, several combination therapies, which are all endocrine-based therapies, are also recommended for the treatment of prostate cancer. CRPC and its Treatment CRPC is prostate cancer that progresses clinically, radiographically or biochemically, despite castrate levels of serum testosterone (<50 ng/dL) in the patient. Patients with prostate cancer that have relapsed after local therapy or that have spread distantly usually respond to androgen deprivation therapy (“ADT”); however, despite receiving ADT, most of these patients eventually experience disease progression and develop CRPC within a median of 18 to 24 months from receiving ADT. A substantial majority of CRPC will be developed into mCRPC. – 100 – THIS DOCUMENT IS IN DRAFT FORM, INCOMPLETE AND SUBJECT TO CHANGE AND THE INFORMATION MUST BE READ IN CONJUNCTION WITH THE SECTION HEADED “WARNING” ON THE COVER OF THIS DOCUMENT INDUSTRY OVERVIEW Treatment options are currently limited for CRPC patients. Common therapies include chemotherapies and endocrine therapies, which can only retard progression by several months, rather than prevent the progression of the disease. New therapeutic drugs are in an advanced stage of clinical testing in order to fill the need for improvement in CRPC treatments. The following chart sets forth the treatment evolution of CRPC: Treatment Evolution of Castration-Resistant Prostate Cancer Radionuclide Traditional Therapy Endocrine Therapy Future Trend Theraphy Androgen Follow-up AR Chemotherapy Drug Biosynthesis Androgen Receptor Inhibitor Radionuclide Signaling Inhibitor Inhibitor Flutamide Enzalutamide Docetaxel Cabazitaxel Abiraterone Apalutamide Radium 223 dichloride Proxalutamide Bicalutamide Darolutamide Source: Frost & Sullivan Report AR antagonists work by blocking androgen receptors in the treatment of prostate cancer. There are currently two generations of AR antagonists, which consist of six drugs approved by the U.S. FDA. The following chart sets forth the evolution of AR antagonists used in the treatment of CRPC: Evolution of AR Antagonists Notes: (1) Nilutamide is not listed here because nilutamide and bicalutamide are all structure optimisation products of Flutamide. (2) Among 2nd generation AR antagonists, Enzalutamide is approved for mCRPC and nmCRPC, Apalutamide and Darolutamide are approved for nmCRPC. Source: Frost & Sullivan Report – 101 – THIS DOCUMENT IS IN DRAFT FORM, INCOMPLETE AND SUBJECT TO CHANGE AND THE INFORMATION MUST BE READ IN CONJUNCTION WITH THE SECTION HEADED “WARNING” ON THE COVER OF THIS DOCUMENT INDUSTRY OVERVIEW The following chart sets forth the recommended CRPC treatment in American Urology Association (“AUA”) guidelines: Recommended Treatment for CRPC Non-metastatic Stage CRPC Metastatic CRPC Asymptomatic or Symptomatic Index Asymptomatic minimally symptomatic No prior Docetaxel chemotherapy Prior Docetaxel chemotherapy Androgen 2nd Generation Good Poor Good Poor Biosynthesis performance performance performance performance AR Antagonists Inhibitor Abiraterone + Prednisone Androgen Androgen Biosynthesis Biosynthesis 2nd Generation Inhibitor Inhibitor Clinicians should Apalutamide AR Antagonists Abiraterone + Abiraterone + offer palliative care Enzalutamide Prednisone Prednisone to the patients, and should not offer 2nd Generation Clinicians should Chemotherapy systemic Chemotherapy AR not offer chemotherapy or Antagonists sipuleucel-T to Cabazitaxel + immunotherapy. Docetaxel + patients. Prednisone Preventive Enzalutamide Prednisone Enzalutamide treatment, like 2nd Generation supplemental AR calcium, vitamin D Immunotherapy Chemotherapy Antagonists should be offered. Docetaxel + Sipuleucel-T Enzalutamide Prednisone Source: Frost & Sullivan Report Global Prostate Cancer Drug Market Size and Growth of Global Prostate Cancer Drug Market The global prostate cancer market grew at a CAGR of 13.8% from US$7.0 billion in 2014 to US$11.8 billion in 2018. The global prostate cancer market is expected to grow at a CAGR of 8.7% from 2018 to US$17.9 billion in 2023 and at a CAGR of 8.1% from 2023 to US$26.4 billion in 2028. Historical and Forecasted of Global Prostate Cancer Drug Market Size, 2014-2028E Period CAGR 2014-2018 13.8% 2018-2023E 8.7% 26.4 Billion USD 2023E-2028E 8.1% 25.1 23.1 21.0 19.3 17.9 16.3 14.5 13.3 11.8 12.5 9.7 8.3 8.9 7.0 2014 2015 2016 2017 2018 2019E 2020E 2021E 2022E 2023E 2024E 2025E 2026E 2027E 2028E Source: Frost & Sullivan Report – 102 – THIS DOCUMENT IS IN DRAFT FORM, INCOMPLETE AND SUBJECT TO CHANGE AND THE INFORMATION MUST BE READ IN CONJUNCTION WITH THE SECTION HEADED “WARNING” ON THE COVER OF THIS DOCUMENT INDUSTRY OVERVIEW Competitive Landscape in the Global Prostate Cancer Drug Market Enzalutamide, Abiraterone acetate and Leuprorelin are the top three drugs in the global prostate cancer market by revenue in 2018, which in total accounted for 69.8% of the overall global prostate cancer market in terms of revenue. The growth rate of Enzalutamide’s and Radium 223 dichloride’s market size during the past five years outperformed the other drugs, with a CAGR of 36.1% and 18.8% from 2014 to 2018, respectively. The following chart sets forth a breakdown of the size of the global prostate cancer drug market in terms of revenue by generic drug segment from 2014 to 2018: Breakdown of Global Prostate Cancer Drug Market Size by Generic Name, 2014-2018 CAGR 14-18 Total 13.8% 11,759.0 Million USD Others 18.6% 1,411.1 9,693.4 414.5 Radium 223 dichloride 18.8% 8,942.0 478.6 1,015.3 498.4 8,251.5 1,215.6 460.1 752.0 482.1 Bicalutamide -5.8% 7,022.0 1,248.6 366.1 435.3 1,049.4 285.0 504.9 735.0 713.7 525.8 395.9 Cabazitaxel 8.3% 208.3 949.0 608.1 356.0 816.0 3,498.0 362.3 816.0 922.7 Goserelin -5.0% 924.0 880.1 2,505.0 904.1 2,260.0 2,231.0 Leuprorelin 3.8% 2,237.0 3,111.6 3,657.1 Abiraterone acetate 11.8% 1,908.9 2,460.9 1,064.6 Enzalutamide 36.1% 2014 2015 2016 2017 2018 Source: Frost & Sullivan Report Enzalutamide is the only approved drug for mCRPC that targets AR in the United States. It also obtained NDA approval for mCRPC in China in November 2019. The following table sets forth the details of Enzalutamide approved by the U.S. FDA and NMPA in China: Clinical Trial Results Unit Generic Company Mechanism of Action Price, Name Indication Efficacy Safety USD Grade 3 and mCRPC following higher AEs = 47%; Median Overall Survival chemotherapy Discontinuation = 18.4 months (versus Placebo) due to AE = 16%; Seizure = 0.9% Blocks androgen bindng to its receptor and prevents Astellas/ 100.6 Enzalutamide nuclear translocation of Pfizer (40 mg) ligand-receptor complex and Grade 3 and Chemotherapy-naïve recruitment of coactivators Median Overall Survival higher AEs = 44%; mCRPC = 35.3 months Discontinuation (versus Placebo) due to AEs = 6% Chemotherapy-naïve Median rPFS Discontinuation mCRPC = 19.5 months due to AEs = 6.3% (versus Bicalutamide) Note: The clinical trial results of Enzalutamide in China are not available. Source: Frost & Sullivan Report – 103 – THIS DOCUMENT IS IN DRAFT FORM, INCOMPLETE AND SUBJECT TO CHANGE AND THE INFORMATION MUST BE READ IN CONJUNCTION WITH THE SECTION HEADED “WARNING” ON THE COVER OF THIS DOCUMENT INDUSTRY OVERVIEW Prostate Cancer Drug Market in China Size and Growth of China’s Prostate Cancer Drug Market China’s prostate cancer drug market grew at a CAGR of 21.6% from RMB1.8 billion in 2014 to RMB4.0 billion in 2018.
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