August 25, 2021, Hong Kong --- Chinese leading biopharmaceutical company 3SBio（01530.HK) today unveiled its 2021 interim results. 3SBio maintained strong performance in core businesses, with core products occupying a leading market share. Meanwhile, the Company continuously increased investments in research and development, while significantly accelerating its pipeline. In the future, 3SBio will reinforce its position as an industry leader by enhancing its competitive edges with further integration of R&D, manufacturing, commercialization and investment cooperation.

Core businesses maintain strong growth and lead the industry 

In first half of 2021, 3SBio posted revenue of approximately RMB 3.11 billion, an increase of 15.3% over the same period last year. Gross profit rose 16.7% year on year to approximately RMB 2.59 billion. Net profit attributable to owners of the parent added 28% on a yearly basis to approximately RMB 900 million. R&D investment increased 35.6% on an annual basis to RMB 340 million.

3SBio’s multiple core products maintained strong momentum and consolidated their positions as market leaders. In the first half of 2021, TPIAO, which is used to treat thrombocytopenia, posted sales of RMB 1.521 billion, an increase of 10.7% year on year, and its market share was 72.3%. Sales of two recombinant human erythropoietin (“rhEPO”) products, EPIAO and SEPO, hit RMB 543 million, marking a year-on-year increase of 17.6%, and a market share of 42.8%. Yisaipu, a product to treat rheumatoid arthritis, ankylosing spondylitis, and psoriasis, had sales of RMB 429 million, a significant rise of 29.5% year on year. Inetetamab was included in the Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Breast Cancer (2021), becoming a cornerstone drug for the whole-process anti-HER2 treatment of patients with advanced breast cancer.

In the first half of 2021, sales of hair growth products led by Mandi doubled year on year. Among them, sales of Mandi (minoxidil tincture) reached RMB 258 million, a year-on-year increase of 100.3%. According to CPA data, Mandi had a share of 71.5% in its category, making itself an absolute market leader. Mandi is now available in more than 2,000 medical institutions, approximately 40,000 retail pharmacies, and e-commerce platforms including Tmall and JD.com, while a strategic partnership has been reached with chain operator Yonghe Hair Transplant. According to the Guidelines for the Diagnosis and Treatment of Androgenetic Alopecia in Chinese Population issued by the Chinese Medical Doctor Association), minoxidil is superior to other types of therapeutic drugs in preventing and improving androgenic alopecia (AGA) in terms of both efficacy and safety, with the highest-level recommendation. There are 250 million people with hair loss in China, and the current market penetration rate of Mandi is only 1-2%. With increasing demand for the treatment of hair loss, Mandi, as a leading OTC drug for external use to improve hair growth, has huge growth potential.

In addition, products in-licensed by 3SBio through partnerships will soon contribute to potential revenue growth. The Phase III clinical bridging trial of Remitch (nalfuraphine hydrochloride orally disintegrating tablets) under the cooperation between 3SBio and Toray, has been successfully completed, and it is expected to become the only product for the treatment of pruritus in patients on maintenance hemodialysis after it goes on the market. Based on the Company’s strong capabilities in sales channels in the nephrology field, the product is expected to benefit millions of Chinese patients.

Apart from strong momentum in core products, 3SBio’s contract development and manufacturing organization (CDMO) business has also seen significant progress in the first half of 2021. Revenue from 3SBio’s CDMO business, consisting of subsidiaries such as Shenyang Desheng, Sunshine Guojian and Italy-based Sirton, posted a year-on-year rise of 9.4% to RMB 40.05 million. Among them, the Shenyang Desheng project has a total planned area of 500 mus, with an aim to build a domestically leading site for biopharma CDMO, biopharma raw and auxiliary supplies and consumables manufacturing and biopharma core process equipment. The site will meet the GMP standards in China, the EU and the United States, and serve global markets. The Phase I CDMO project at Shenyang Desheng, covering an area of more than 110 mus, is planned to have annual capacities of 199,000 liters of original solutions and 1 billion doses of injections. Initially, the production capacity of 76,000 liters will be put into operation in 2022.

Accelerating the pipeline development

In terms of R&D, 3SBio has been accelerating its pipeline via in-house projects and external partnerships. In the first half of 2021, 3SBio had a total of 35 product candidates under its pipeline, of which 24 were developed as innovative drugs in China. The candidates included 21 monoclonal antibodies or bispecific antibodies, 5 other biological products, and 9 small molecule drugs. There are 14 candidates in oncology, 14 in autoimmune and other diseases, 6 in nephrology, and 1 in dermatology.

   6 projects with NDA submissions or in Phase III clinical trials

The New Drug Application (NDA) of pre-filled aqueous injection solution Yisaipu (301S) was accepted by the National Medical Products Administration (NMPA) of China in July 2021.

The Phase III clinical trial of nalfurafine hydrochloride (TRK820) under a partnership with Japan’s Toray for the treatment of refractory pruritus in patients on maintenance hemodialysis met the pre-defined endpoint, and the results were consistent with those of the Phase III trial in Japan.

The Phase III head-to-head study between minoxidil foam formulation MN709 and Rogaine® in male patients with hair loss was completed, and the results are expected to be presented in the third quarter of 2021. 

The Phase III clinical trial of TPIAO for immune thrombocytopenic purpura (ITP) in children has been launched. In addition, the Phase Ib/II clinical trial of TPIAO for the mobilization of patients with chronic liver dysfunction at risk of thrombocytopenia in the perioperative period has also been launched.

The combination therapy SEL-212 containing SSS11pegitiscase has started the Phase III clinical trial in patients with chronic refractory gout in the United States. The Company is currently conducting the Phase I clinical trial of SSS11 in refractory gout patients with high levels of uric acid.

The Phase III clinical trial of 304R, an anti-CD20 monoclonal antibody, has completed the data review. The Company has also completed the Phase I head-to-head comparative clinical trial with Rituxan (rituximab) on the safety and pharmacokinetics in patients with non-Hodgkin’s lymphoma with zero tumor burden.

8 products in Phase II clinical trials

The randomized Phase II clinical trial of the long-acting erythropoietin SSS06 has completed patient enrolment.

The dose-escalation Phase I clinical trial to evaluate the safety and pharmacokinetics of the long-acting erythropoietin RD001 in healthy volunteers was completed. The patient enrolment for the Phase II clinical trial is ongoing.

The dose-escalation Phase I clinical trial of 608, an anti-IL-17A monoclonal antibody, in healthy volunteers was completed, and the Phase II clinical trial in patients with plaque psoriasis is ongoing.

The dose-escalation Phase I clinical trial of 610, an anti-IL-5 monoclonal antibody, in healthy volunteers was completed, and the Phase Ib/II trial in asthma patients will soon be launched.

The Phase I clinical trial of SSS07, an anti-TNFα monoclonal antibody, in healthy volunteers and patients with pheumatoid arthritis was completed.

The two dose-escalation Phase I/IIa clinical trials of 601A, an anti-VEGF monoclonal antibody, in patients with age-related macular degeneration (AMD) and diabetic macular edema (DME) were completed. Three Phase II clinical trials in patients with branch retinal vein occlusion (BRVO), central retinal vein occlusion (CRVO), and pathological myopic choroidal neovascularization (pmCNV) have been launched.

Two Phase I clinical trials of 602, an anti-EGFR monoclonal antibody, in healthy volunteers and patients with colorectal cancer were completed, and the Phase II clinical trial in patients with colorectal cancer has been launched.

The IND of the Phase I/II clinical trials of 302H, an anti-HER2 monoclonal antibody, in combination with 602 in patients with HER2-positive, KRAS/NRAS/BRAF wild-type colorectal cancer has been approved by the NMPA. In addition, the INDs of the clinical trials of 302H in combination with IMM01, an anti-CD47 fusion protein, in patients with HER2-positive solid tumors, and 302H in combination with 609A, an anti-PD1 monoclonal antibody, for neoadjuvant treatment of breast cancer have been submitted to the NMPA.

   6 products in Phase I clinical trials or with IND approvals/submissions  

The Phase I clinical trial of 609A, an anti-PD1 monoclonal antibody, in patients with multiple types of cancer was completed in the United States, and the Phase I clinical trial in China has wrapped up patient enrolment. The IND of 609A in combination with 302H, bevacizumab and chemotherapy in patients with multiple types of cancer has been submitted to the NMPA.

The dose-escalation Phase I clinical trial of 611, an anti-IL-4Rα monoclonal antibody, in healthy volunteers was completed in the United States, and the Phase Ib/II clinical trial in patients with atopic dermatitis is ongoing in China.

Patient enrolment for the Phase I clinical trial of HIF-117 in patients with anemia is ongoing.

The IND of 612, an anti-HER2 monoclonal antibody for the treatment of HER2-positive cancer, has been approved by the NMPA.

The two INDs of clinical trials of 613, an anti-IL-1β monoclonal antibody, have been approved by the NMPA for the treatment of patients with juvenile idiopathic arthritis (JIA) and periodic fever syndrome.

The IND of 705, an anti-PD1/HER2 bispecific antibody, has been approved by the US FDA for the treatment of patients with HER2-positive solid tumors, and the IND in China has been submitted to the NMPA.

Constantly improved comprehensive platform capabilities

In 2021, 3SBio has been stepping up efforts to improve its comprehensive capabilities by leveraging the integration of R&D, manufacturing, commercialization and investment cooperation. The Company has been focused on developing innovative biologics products to address unmet medical needs.

3SBio has been focused on building up its in-house clinical R&D capabilities with a R&D team of nearly 600 people. The Company is among first-tier players in China in the field of autoimmune diseases, with a pipeline of anti-IL-4Rα antibody, anti-IL-5 antibody and anti-IL-17A antibody. In oncology, the Company has been focused on the development of new next-generation biological therapies including, programmed CAR-T cell therapies, immune checkpoint inhibitors, macrophage checkpoint modulators, bispecific antibodies and other new antibodies, antibodies against new targets and combination therapies. On the other hand, 3SBio has also been proactively collaborating with the world’s leading technology platforms and biotech companies to develop high-quality drugs, and introducing leading global products into China. Partners include Toray, Samsung Bioepis, Refuge Biotechnologies, Verseau, TLC, Gensight, and Sensorion. In the next 12 months, 3SBio is expected to submit multiple IND applications.

Meanwhile, the Company has continuously improved its multiple advantages in the field of CDMO business. 3SBio can support the production of multiple biological drugs, including monoclonal antibodies, bispecific antibodies, neutralizing antibodies, vaccines, and nucleic acid-based (mRNA) drugs to address end-to-end needs from early-stage sample structure analysis to post-launch commercialization. The production line is equipped with reactors with diverse scales, enabling it to address different scenarios for small-batch sample testing and large-batch commercial production. The total production capacity exceeds 200 million doses, covering biological preparations such as vials, freeze-dried powder injections, and prefilled injections. The Company’s CDMO production line has obtained GMP certifications from China, Brazil, Colombia, Ukraine, and the European Union, and has successfully passed all inspections by the regulatory authorities. 3SBio has end-to-end technological advantages from R&D to biopharma manufacturing, and cost advantages for commercial production with its 10,000-liter single bioreactor. The Company has additional cost advantages by self-producing raw materials such as culture media and chromatography fillers, as well as quality control advantages with a high level of automation. All these have enabled the Company to sustainably provide high-quality biopharma products and CDMO services for the markets.

As of June 31, 2021, 3SBio had close to 3,000 staffers in its sales and marketing teams, with business presence across the country. In addition, products such as TPIAO, Yisaipu, EPIAO and SEPO have been shipped to many countries.

Dr. Jing LOU, Chairman of 3SBio, commented: “In the first half of 2021, 3SBio posted significant growth in core businesses, laying a solid foundation for its full-year performance. The Company has proactively responded to the country’s initiative to provide healthcare for people in lower-tier regions, and stepped up efforts to improve the access to biological drugs at the primary care level. Meanwhile, the Company accelerated the research and development of proprietary innovative biological medicines, and provided safe and effective hair loss treatment to the market. The Company has a number of in-house core products, with stable cash flows and financial performance, setting the stage for its long-term sustainable development. 3SBio is committed to addressing unmet clinical needs, continuously improving innovation and R&D capabilities, benefiting patients with high-quality drugs, and creating greater value for our shareholders and the broader society.”

Cautionary Note and Forward-Looking Statements

This press release contains forward-looking statements, such as those relating to business orproducts outlook, or Company’s intent, plans, beliefs, expectation and strategies. These forwardlookingstatements are based on information currently available to the Company and are statedherein on the basis of the outlook at the time of this press release. They are based on certainexpectations, assumptions and premises, some of which are subjective or beyond our control.These forward-looking statements may prove to be incorrect or may not be realized in the future.With respect to any new product or new indication, we cannot guarantee that we will be able tosuccessfully develop or eventually launch and market such product or indication. Underlyingthe forward-looking statements is a large number of risks and uncertainties. Further informationregarding such risks and uncertainties may be found in our other public disclosure documents.The scientific information involved may only be preliminary and empirical. Shareholders andpotential investors of the Company are advised to exercise caution when dealing in the shares of the Company.