(Incorporated in the Cayman Islands with limited liability)
Stock Code : 1530 Convertible Bonds Code 40285
INTERIM REPORT
Contents
- Company Overview
-
Corporate Information
5 Financial Highlights
6 Management Discussion and Analysis
26 Corporate Governance and Other Information
38 Independent Review Report
40 Interim Condensed Consolidated Statement of Profit or Loss
41 Interim Condensed Consolidated Statement of Comprehensive Income
42 Interim Condensed Consolidated Statement of Financial Position
44 Interim Condensed Consolidated Statement of Changes in Equity
46 Interim Condensed Consolidated Statement of Cash Flows
48 Notes to Interim Condensed Consolidated Financial Information
Company Overview
3SBio Inc. (the "Company" or "3SBio", with its subsidiaries collectively, the "Group") is a leading biotechnology company in the People's Republic of China (the "PRC"). As a pioneer in the Chinese biotechnology industry, the Group has extensive expertise in researching, developing, manufacturing and marketing bio-pharmaceuticals. The core products of the Group include several bio- pharmaceutical drugs, TPIAO (特比澳), recombinant human erythropoietin ("rhEPO") products EPIAO (益比奥) and SEPO (賽博爾), Yisaipu (益賽普) and Cipterbin (賽普汀), and a small molecule drug, Mandi (蔓迪). TPIAO is the only commercialized recombinant human thrombopoietin ("rhTPO") product in the world. According to IQVIA1, the market share in the treatment of thrombocytopenia of TPIAO in Mainland China2 was 66.2% in the first half of 2024 in terms of sales value. With its two rhEPO products, the Group has been the premier market leader in the Mainland China rhEPO market for over two decades, holding a total market share of 42.7% in the first half of 2024. Yisaipu is the first-to-market Tumour Necrosis Factor ("TNF") α inhibitor product in Mainland China. Mandi has a dominant position in the Mainland China minoxidil market. The Group has been expanding its therapeutic coverage by adding products through internal research and development ("R&D") and various external strategic partnerships. In the first half of 2024, the Group introduced Semaglutide Injection, actively deploying in the domestic weight management market.
As at 30 June 2024, amongst the 28 product candidates within the Group's active pipeline, 25 were being developed as innovative drugs in Mainland China. Out of these product candidates, 15 are antibodies, 7 are other biologic products, and 6 are small molecule entities. The Group has 12 product candidates in hematology/oncology; 10 product candidates that target auto-immune diseases including rheumatoid arthritis ("RA") and other diseases including refractory gout and ophthalmological diseases such as branch retinal vein occlusion ("BRVO"); 4 product candidates in nephrology; 1 product candidate in dermatology and 1 product candidate in metabolic diseases.
The Group operates in a highly attractive industry. Biotechnology has revolutionized the pharmaceutical industry by addressing unmet medical needs and offering innovative treatments for a wide array of human diseases. In Mainland China, the biotechnology industry enjoys strong government support and has been selected by the State Council of the PRC as a key strategic emerging industry. Strong government support along with increasing physician adoption of biopharmaceuticals has driven strong industry growth in Mainland China.
The Group is positioned for global expansion. In the six months ended 30 June 2024 (the "Reporting Period"), the Group's products were sold in 16 countries. In the long-term, the Group aims to market its products in developed countries. Furthermore, the Group is collaborating with international partners to develop and market the Group's product candidates, such as pegsiticase and anti-programmed cell death protein 1 ("PD-1") monoclonal antibody ("mAb"). The Group aims to focus its R&D to provide innovative therapeutics for patients in Mainland China and globally.
As at 30 June 2024, the Group had operation facilities in Shenyang, Shanghai, Hangzhou and Shenzhen, all in Mainland China, as well as in Como, Italy, with 5,607 employees. The Group's pharmaceutical products are marketed and sold in all provinces, autonomous regions and special municipalities in Mainland China, as well as a number of foreign countries and regions. During the Reporting Period, the Group's nationwide sales and distribution network enabled it to sell its products to over 9,700 hospitals and medical institutions in Mainland China.
- All market share information throughout this report cites the IQVIA data, unless otherwise noted.
- Hereinafter referred to as the mainland area of the PRC.
- 3SBIO INC.
Corporate Information
BOARD OF DIRECTORS
Executive Directors
Dr. LOU Jing (Chairman & Chief Executive Officer)
Ms. SU Dongmei
Non-executive Directors
Ms. ZHANG Jiaoe (appointed on 25 June 2024)
Mr. HUANG Bin (retired on 25 June 2024)
Independent Non-executive Directors
Mr. PU Tianruo
Ms. YANG, Hoi Ti Heidi
Mr. NG, Joo Yeow Gerry
Dr. ZHANG Dan (retired on 25 June 2024)
COMPANY SECRETARY
Ms. LAI Siu Kuen
AUTHORIZED
REPRESENTATIVES
Ms. SU Dongmei
Ms. LAI Siu Kuen
AUDIT COMMITTEE
Mr. PU Tianruo (Chairman)
Ms. YANG, Hoi Ti Heidi
Mr. NG, Joo Yeow Gerry
REMUNERATION COMMITTEE
Ms. YANG, Hoi Ti Heidi (Chairwoman)
Mr. PU Tianruo
Mr. NG, Joo Yeow Gerry (appointment effective on 25 June 2024)
Dr. ZHANG Dan (committee membership ended upon retirement on 25 June 2024)
NOMINATION COMMITTEE
Dr. LOU Jing (Chairman)
Mr. PU Tianruo
Mr. NG, Joo Yeow Gerry
REGISTERED OFFICE
(IN THE CAYMAN ISLANDS)
Cricket Square, Hutchins Drive
PO Box 2681
Grand Cayman, KY1-1111
Cayman Islands
HEADQUARTERS
No. 3 A1, Road 10
Shenyang Economy and Technology Development Zone
Shenyang
PRC
PRINCIPAL PLACE OF BUSINESS IN HONG KONG
5/F, Manulife Place
348 Kwun Tong Road
Kowloon
Hong Kong SAR
PRC
PRINCIPAL SHARE REGISTRAR AND TRANSFER OFFICE
Conyers Trust Company (Cayman) Limited
Cricket Square, Hutchins Drive
PO Box 2681
Grand Cayman, KY1-1111
Cayman Islands
Interim Report 2024 | 3 |
Corporate Information
HONG KONG SHARE REGISTRAR
Computershare Hong Kong Investor Services Limited
Shops 1712-1716, 17th Floor
Hopewell Centre
183 Queen's Road East
Wanchai, Hong Kong SAR
PRC
LEGAL ADVISERS
As to Hong Kong law and United States law:
Baker & McKenzie
14th Floor, One Taikoo Place
979 King's Road
Quarry Bay
Hong Kong SAR
PRC
As to PRC law:
Jingtian & Gongcheng
34th Floor, Tower 3, China Central Place
77 Jianguo Road
Chaoyang District
Beijing, PRC
As to Cayman Islands law:
Conyers Dill & Pearman
29th Floor, One Exchange Square
8 Connaught Place
Central
Hong Kong SAR
PRC
AUDITOR
Ernst & Young
Certified Public Accountants
Registered Public Interest Entity Auditor
27th Floor, One Taikoo Place
979 King's Road
Quarry Bay
Hong Kong SAR
PRC
SECURITIES CODE
Shares Listing
Ordinary Shares
The Stock Exchange of Hong Kong Limited
(Stock Code: 01530)
COMPANY'S WEBSITE
www.3sbio.com
PRINCIPAL BANK
Industrial Bank Co., Ltd., Shenyang Branch
No. 77 Wenhua Road
Heping District
Shenyang, PRC
- 3SBIO INC.
Financial Highlights*
- Revenue increased by RMB605.6 million or 16.0% to RMB4,389.4 million, as compared to the six months ended 30 June 2023.
- Gross profit increased by RMB595.8 million or 18.6% to RMB3,797.4 million, as compared to the six months ended 30 June 2023. The gross profit margin increased to 86.5% from 84.6% for the six months ended 30 June 2023.
- Net profit attributable to owners of the parent increased by RMB109.3 million or 11.1% to RMB1,089.9 million, as compared to the six months ended 30 June 2023. Net profit attributable to owners of the parent adjusted for non- operating items3 increased by RMB16.7 million or 1.5% to RMB1,112.4 million, as compared to the six months ended 30 June 2023.
- EBITDA increased by RMB311.0 million or 23.4% to RMB1,641.5 million, as compared to the six months ended 30 June 2023. EBITDA adjusted for non-operating items4 increased by RMB241.6 million or 17.0% to RMB1,663.9 million, as compared to the six months ended 30 June 2023.
- All numbers in the "Financial Highlights" section are subject to rounding adjustments and therefore are approximate numbers only.
- The net profit attributable to owners of the parent adjusted for non-operating items is defined as the profit attributable to owners of the parent for the period excluding, as applicable: (a) the interest expenses incurred in relation to the Euro ("EUR") denominated zero-coupon convertible bonds in an aggregate principal amount of EUR320,000,000 due 2025 ("2025 Bonds"); (b) the expenses associated with the share options and awarded shares granted in March 2020; (c) the expenses associated with the awarded shares under an employee share ownership plan (the "ESOP") by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. ("Sunshine Guojian"), an indirect non-wholly owned subsidiary of 3SBio; (d) gain on redemption of 2025 Bonds; (e) fair value gains or losses on financial assets at fair value through profit or loss ("FVTPL"); and (f) non-operating foreign exchange differences.
- The EBITDA adjusted for non-operating items is defined as the EBITDA for the period excluding the same items as listed in footnote 3 above.
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Management Discussion and Analysis
BUSINESS REVIEW
Key Events
Mandi Foam Approved for Market Launch
As announced on 8 January 2024, the application for market launch of Mandi (5% minoxidil) Foam as an over-the-counter drug for the treatment of androgenetic alopecia and alopecia areata by 3SBio's subsidiary, Zhejiang Sunshine Mandi Pharmaceutical Co., Ltd. ("Sunshine Mandi", formerly known as Zhejiang Wansheng Pharmaceutical Co., Ltd.), to the PRC National Medical Products Administration ("NMPA") has been approved.
Mandi Foam is the first domestic minoxidil foam approved for market launch. Its successfully completed phase III study showed Mandi Foam being of equivalent efficacy and similar safety and tolerability as ROGAINE®, the leading minoxidil drug in the U.S. Minoxidil is currently a first-line topical drug for the clinical treatment of androgenetic alopecia. Mandi Foam has better transdermal speed and scalp accumulation rate, with milder scalp tolerance, rendering it a better choice for alopecia users.
TPIAO Approved for Pediatric ITP Indication
TPIAO, which was submitted for the new indication of treatment of persistent or chronic immune thrombocytopenia ("ITP") in children or adolescents to the NMPA, has been approved on 2 April 2024.
Primary ITP is an acquired autoimmune hemorrhagic disease. Pediatric ITP is often characterized by sudden petechiae, ecchymosis or bleeding in children who are normally healthy. Occasionally, thrombocytopenia is found in patients who undergo whole blood cell counts due to other conditions.
Semaglutide (Weight Management) Cooperation
As announced on 28 May 2024, Sunshine Mandi entered into the Semaglutide Injection Cooperation Agreement (the "Agreement") with Hybio Pharmaceutical Co., Ltd. ("Hybio Pharmaceutical"). Pursuant to the Agreement, Hybio Pharmaceutical and Sunshine Mandi will jointly develop, and supply/purchase on an exclusive basis, the Semaglutide Injection in weight management indication ("Semaglutide WM") and share the profits from its sales. Sunshine Mandi will pay Hybio Pharmaceutical milestone payments of up to RMB270 million under the Agreement, including a consideration for preclinical technical results of RMB45 million, in addition to an exclusive procurement price and royalties. Sunshine Mandi will receive the preclinical technical research results of the cooperation product from Hybio Pharmaceutical and entrust Hybio to provide clinical research and registration application services, with Sunshine Mandi to be the marketing authorization holder (MAH) of Semaglutide WM in certain regions. Sunshine Mandi shall acquire the right to market the product exclusively and be responsible for the commercialization of the product in the region; meanwhile, Sunshine Mandi will entrust Hybio Pharmaceutical to be responsible for the exclusive production and supply of Semaglutide WM. After the launch of the product, Sunshine Mandi will pay Hybio Pharmaceutical two-digit royalties based on the gross profit derived from the net sales of the product in the region in each calender year.
- 3SBIO INC.
Management Discussion and Analysis
Key Products
- Bio-pharmaceuticals
TPIAO
TPIAO is the Group's self-developed proprietary product, and has been the only commercialized rhTPO product in the world since its launch in 2006. TPIAO has been approved by the NMPA for three indications: the treatment of chemotherapy-induced thrombocytopenia ("CIT"), ITP and pediatric ITP. TPIAO has the advantages of higher efficacy, faster platelet recovery and fewer side effects as compared to alternative treatments for CIT and ITP.
TPIAO has been listed on the National Reimbursement Drug List for Basic Medical Insurance, Work-Related Injury Insurance and Maternity Insurance 《( 國家基本醫療保險、工傷保險和生育保險藥品目錄》) ("NRDL") as a Class B Drug for the treatment of CIT in patients with solid tumors or ITP since 2017. In the "Guidelines of CSCO - Cancer Therapy Induced Thrombocytopenia ("CTIT") (2024 version)"5, rhTPO is listed as a treatment choice with the highest level recommendation, the Grade I recommendation. According to the "Adapted Guideline for the Diagnosis and Treatment of Primary Immune Thrombocytopenia for Chinese Children (2021)"6, rhTPO is the preferred choice among the conventional second line treatments. According to the "Chinese Guideline on the Diagnosis and Management of Adult Primary Immune Thrombocytopenia (2020 version)"7, rhTPO is one of the primary treatments for ITP emergency cases and is the preferred choice in the second line treatments list for both ITP and ITP in pregnancy. In "Consensus on the Clinical Diagnosis, Treatment, and Prevention of Chemotherapy-InducedThrombocytopenia in China (2019 version)"8, rhTPO is one of the primary treatments for CIT. rhTPO has also received similar professional endorsements in several national guidelines and experts consensus on treating certain other diseases in Mainland China.
Future growth of TPIAO may be driven by: 1) the enhanced market position as for inpatients attributable to its safety and efficacy, and its continually supplanting traditional interleukin ("IL") platelet-raising drugs in clinical use; 2) the continued increase in the number of hospitals covered; and 3) the expansion of indications. In the first half of 2024, its market share for the treatment of thrombocytopenia in Mainland China was 34.5% in terms of sales volume and 66.2% in terms of sales value. The supplemental New Drug Application ("NDA") for treatment of persistent or chronic primary ITP in children or adolescents has been approved by the NMPA on 2 April 2024. In July 2024, the primary endpoint has been achieved in the trial of phase III clinical study of TPIAO in the treatment of patients with chronic liver disease ("CLD") related thrombocytopenia who are candidates for invasive surgery. 3SBio submitted a marketing application for this indication to the NMPA in August 2024 and the application was accepted. Outside of Mainland China, TPIAO is in the process of registration in several countries in Asia and Africa.
- Issued by the Chinese Society of Clinical Oncology ("CSCO")
- Issued by the Subspecialty Group of Hematologic Diseases, the Society of Pediatrics, Chinese Medical Association (the "CMA"); the Editorial Board, Chinese Journal of Pediatrics
- Issued by the Thrombosis and Hemostasis Group of the Chinese Society of Hematology of the CMA
- Issued by the Society of Chemotherapy, China Anti-Cancer Association; and Committee of Neoplastic Supportive-Care (CONS), China Anti-Cancer Association
Interim Report 2024 | 7 |
Management Discussion and Analysis
EPIAO
EPIAO is approved by the NMPA for the following three indications: the treatment of anemia associated with chronic kidney disease ("CKD"), the treatment of chemotherapy-induced anemia ("CIA"), and the reduction of allogeneic blood transfusion in surgery patients. rhEPO products has been listed on the NRDL as a Class B Drug for renal anemia since 2000, for CIA in patients with non-hematological malignancies since 2019, and, additionally, rhEPO products for the reduction of allogeneic blood transfusion in surgery patients also is under NRDL coverage since 2024. EPIAO has also been listed on the 2018 National Essential Drug List. EPIAO has consistently been the premier market leader in the Mainland China rhEPO market since 2002 in terms of both sales volume and sales value. EPIAO and SEPO together claim a majority market share of the Mainland China rhEPO market at 10,000 IU dosage. The Group believes that, 1) the continuous expansion of the dialysis market; 2) the coverage reduction of allogeneic blood transfusion in surgery patients in the NRDL; 3) the improvement of anemia treatment standards; 4) the improvement of the diagnosis and treatment rate of cancer anemia; and 5) the proactive going-deep strategy in the lower-tier market, will continue to drive the further growth of clinical applications of its erythropoietin products. The multi-center biosimilar clinical trials for EPIAO in Russia and Thailand were completed in 2021. EPIAO demonstrated promising effectiveness and manageable safety in patients with end-stage renal disease on hemodialysis. EPIAO is in the process of registration in several countries.
Yisaipu
Yisaipu (Recombinant Human TNF-α Receptor II: IgG Fc Fusion Protein for Injection), is a TNF-α inhibitor product. It was first launched in 2005 in Mainland China for RA. Its indications were expanded to ankylosing spondylitis ("AS") and psoriasis in 2007. Yisaipu has been listed on the NRDL as a Class B Drug since 2017 for RA and for AS, each subject to certain medical prerequisites, and additionally, since 2019 for the treatment of adult patients with severe plaque psoriasis. Yisaipu is the first-to-marketTNF-α inhibitor product in Mainland China that filled a gap among domestic peers in regard to the fully-human therapeutic antibody-drugs. Compared with competitors, the efficacy and safety of Yisaipu have been proven in the domestic market over nearly two decades. In "2018 China Rheumatoid Arthritis Treatment Guidance", an authoritative document issued by the CMA, Yisaipu was adopted under 'TNF-α inhibitors' as one of the RA treatment options, and TNF-α inhibitors was deemed as a group of biological agents with relatively sufficient evidence and relatively wide adoption in treating RA. TNF-α inhibitors have been recommended in a number of professional guidelines, such as "EULAR Recommendations for the Management of Rheumatoid Arthritis with Synthetic and Biological Disease-Modifying Anti-rheumaticDrugs: 2022 Update", "Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA): Updated Treatment Recommendations for Psoriatic Arthritis 2021" and "Recommendations for Diagnosis and Treatment of Ankylosing Spondylitis"9. In 2024, Yisaipu will actively embrace centralized procurement to further promote the concept of long-term benefits of early-stage biotherapy and encourage its use early in the treatment process. It will continue to enhance its awareness and application within the medical profession and market growth of rheumatic immune biological agents in key third and fourth tier cities, and meanwhile, actively expand the application of Yisaipu in different departments and fields including Chinese traditional medicine. The NDA for the pre-filled aqueous injection solution of Yisaipu (Group R&D code: 301S) was approved by the NMPA in March 2023. The launch of prefilled syringe of Yisaipu improves patient convenience and enhances the overall market competitiveness of Yisaipu.
- Issued by Chinese Rheumatology Association of the CMA, Chin J Intern Med, August 2022, Vol. 61, No. 8
- 3SBIO INC.
