March 29, 2022, Hong Kong --- Chinese leading biopharmaceutical company 3SBio（01530.HK) today unveiled its 2021 annual results. Revenue in 2021 increased by 14.2% year on year to RMB 6.38 billion. Net profit attributable to owners of the parents rose by 97.6% year on year to RMB 1.65 billion. Earnings per share was HKD 0.8, up 97.1% on a yearly basis. Research and development costs jumped by 28% to RMB 750 million. 3SBio continued to be rated A in MSCI ESG Ratings in 2021, surpassing 78% of the world’s biotech companies. The Company has been named in the List of Top 100 Chinese Pharmaceutical Companies for the sixth consecutive year, with its ranking up by 5 notches compared with the previous year.

Core businesses continued to grow, with NDA of product candidate accepted

In 2021, 3SBio’s main business revenue maintained growth for the fifth straight year, with a compound annual growth rate of 14.3%. Sales revenue of core products achieved robust double-digit growth, and the gross profit margin remained stable at over 80%. The Company demonstrated strong abilities to generate cash flows.

Sales of TPIAO rose 11.5% year on year to RMB 3.08 billion, with a market share of 72.1%. Last year, TPIAO’s sales growth was driven by the continued increase in the number of hospitals covered, the reduced pressure on patients under new medical insurance payment pricing, and the enhanced market position for in-patients attributable to its safety and efficacy, and its continually supplanting traditional IL platelet-raising drugs in clinical use. The penetration rates for CIT and ITP indications in China’s mainland were estimated at approximately 27% to 35%. Outside of China’s mainland, TPIAO has been approved in nine countries, including the Philippines and Thailand. Currently, the European filing for TPIAO has been initiated.

The combined sales of EPIAO and SEPO rose 15% year on year to RMB 1.12 billion, with a market share of 42.4%, as they’ve consistently been the market leader in the domestic rhEPO market. In 2021, the continuing sales growth of EPIAO was mainly derived from the increase in the number of basic medical institutions covered, inclusion in the National Essential Drug List, and the greater willingness for prescription at the grassroot level; and its clinical edges over oral drugs in terms of cost effectiveness and safety. Up to now, EPIAO has been approved in 23 countries, including Thailand and Pakistan.

Sales of Yisaipu rose 28% year on year to RMB 790 million, mainly attributable to increased sales volume which was driven by price reduction, and sales volume jumped 90% year on year. As the first TNF-α inhibitor approved in China’s mainland, Yisaipu were sold in more than 3,700 hospitals in the mainland, including almost 1,700 Grade III hospitals, in 2021. Currently, the usage rate of biologic anti-rheumatic drugs in China is far lower than that in North America, indicating huge growth potential. In the past year, Yisaipu saw continued penetration into lower-tier regions, covering more than 670 county-level markets and more than 900 county-level hospitals.

The new drug application (NDA) of core product candidate Remitch has been submitted and accepted. In December 2021, the NDA of nalfuraphine hydrochloride orally disintegrating tablets (R&D code: TRK-820, marketed in Japan as “Remitch”) in collaboration with Toray Industries Inc. (Toray) was accepted for review by the National Medical Products Administration of China. The Company is actively preparing for the product launch. TRK-820 is a highly selective κ (kappa)-opioid receptor agonist developed by Toray. According to the results of the bridging clinical study in China, doses of 5µg and 2.5µg of nalfuraphine hydrochloride orally disintegrating tablets can safely improve the symptoms of hemodialysis patients with refractory pruritus when compared with the placebo. TRK-820 is the first drug in China’s mainland targeting hemodialysis pruritus with an expected early market launch, and is expected to alleviate the pruritus symptoms and improve patient quality of life, thereby bringing benefits to the large number of hemodialysis pruritus patients in China’s mainland.

Hair health business posted robust growth across channels

Driven by the “beauty value economy”, more and more people care about hair loss, and the hair health market features huge growth potential.

Mandi, a hair loss treatment developed by 3SBio, has seen rapid growth in recent years. Mandi, generically known as minoxidil tincture, was launched in 2001 as the first over-the-counter (OTC) drug in China’s mainland for androgenetic alopecia (AGA) and alopecia areata. Minoxidil is the world’s only topical OTC drug for male and female alopecia that was approved by the U.S. Food and Drug Administration (FDA) and the NMPA of China. In 2021, Mandi achieved sales revenue of RMB 602  million, a year-on-year increase of 63.7%. It has maintained rapid growth for six consecutive years. According to data by the Chinese Pharmaceutical Association (CPA), Mandi had a market share of 71.2% in China’s mainland in 2021, making it an absolute market leader.

Mandi’s rapid growth in 2021 benefited from the following drivers.

The first driver was coverage expansion in medical institutions. Mandi has been introduced into more than 700 active hair clinics in China and its coverage continues to expand. The medical institutions have seen Mandi’s safety and effectiveness tested for more than 10 years, with more than 1 million patients treated and the number increasing. Revenue of Mandi from medical institutions accounted for approximately 20% of its total revenue, an increase of approximately 35% year on year.

The second driver was expansion of coverage of retail pharmacies. As Mandi currently has low coverage in retail pharmacies, there is potential for improvement. Revenue of Mandi from retail pharmacies accounted for approximately 23% of its total revenue, an increase of 150% year on year. It is expected that the coverage of retail pharmacies will be expanded through marketing activities.

The third driver was online brand operation. Mandi has been launched in online stores such as AliHealth Pharmacy, JD Pharmacy and brand flagship stores. The digital marketing system accurately reaches and converts potential customers, and the refined operation in and outside websites will continuously boost consumption on e-commerce platforms. Revenue of Mandi from e-commerce accounted for approximately 57% of its total revenue, an increase of 55% year on year.

The fourth driver was the potential launch of new product formulation. The phase III study of the foam form of Mandi, comparing head-to-head in male hair loss patients to Rogaine®, the leading minoxidil drug in the U.S., has been successfully completed, showing Mandi foam being of equivalent efficacy and similar safety and tolerability. In 2021, the application for market launch of Mandi foam was accepted by the NMPA. If approved, Mandi will likely be the only minoxidil foam in the Chinese mainland market, which will significantly improve its market competitiveness.

In China’s mainland, the current penetration rate of Mandi is only 1–2% among the 250 million hair loss population. The Company focuses on greater brand promotion of Mandi and on improving recognition of drug treatment effectiveness for hair loss. With greater promotion, the enhanced penetration rate will continue to expand the market potential of Mandi.

Multiple R&D breakthroughs achieved, with a milestone in out-licensing

In 2021, 3SBio further accelerated research and development, with a total R&D expenditure of RMB 750 million, an increase of almost 28% compared to last year. The Company has been consistently pursuing excellence in innovation and technology in its R&D planning. There are 33 product candidates within the active pipeline, with 26 being developed as innovative drugs in China’s mainland. Among them, there are 10 product candidates in oncology, 16 product candidates that target auto-immune diseases, six product candidates in nephrology; and one product candidate in dermatology.

3SBio’s R&D pipeline as of the end of 2021

NDA submission and phase III development:

l  Anti-TNF a pre-filled aqueous injection solution of Yisaipu (301S): The Company has re-submitted an NDA to the NMPA for manufacturing approval in July 2021. The application was accepted for review by the NMPA.

l  Minoxidil foam formulation (MN709): The Company has completed a multi-centered, randomized, and double-blinded phase III study comparing head-to-head of MN709 to Rogaine® in male patients with hair loss. The study demonstrated positive results and an NDA to the NMPA was accepted for review.

l  Narfuraphine hydrochloride (TRK820): The phase III clinical trial on narfuraphine hydrochloride orally disintegrating tablets for treatment of maintenance hemodialysis patients with refractory pruritus has reached the pre-set clinical study endpoint. The results were consistent with those of Japan’s phase III trial. The NDA has been submitted to the NMPA and was accepted for review.

l  TPIAO (TPO): The Company has started a phase III clinical trial of TPIAO in the pediatric ITP indication. A phase I clinical trial for TPIAO in surgery patients with chronic hepatic dysfunction at the risk of thrombocytopenia has been completed, and the phase Ib/II trial is ongoing.

l  NuPIAO (EPO, SSS06): The Company has completed a phase II clinical trial, and completed the data readout. The Company has kicked off a phase III trial of the product in November 2021, and started patient enrollment before the end of 2021.

Phase II development:

l  Peg-EPO (RD-01): The Company has completed a dose-escalating phase I safety and pharmacokinetics study of RD-01 in healthy volunteers. Patient enrollment in a randomized phase II clinical trial was completed by the end of December 2021.

l  Anti-PD1 mAb (609A): The Company has completed a U.S. phase I trial of 609A in patients with various cancers. Its phase II trials in China’s mainland are ongoing.

l  Anti-IL17A mAb (608): The phase II trial of 608 in patients with plaque psoriasis has completed patient enrollment. The phase III trial is expected to initiate before the end of 2022. The Company submitted an IND application for 608 in Axial Spondyloarthritis (SpA) indication in March 2022.

l  Anti-VEGF mAb (601A): The Company has initiated the phase II trial in patients with branch retinal vein occlusion (BRVO).

l  Anti-EGFR mAb (602): The Company has completed two phase I trials of 602: one in healthy volunteers and the other in patients with colorectal cancer, and has initiated a phase II clinical trial of the product in patients with colorectal cancer. Patient enrollment was completed in October 2021.

l  Anti-IL1 b mAb (613): The Company received an IND approval from the NMPA for 613 in acute gout (AG) indication, with the phase Ib/II trial now in initiation.

l  Anti-HER2 mAb (inetetamab, 302H): In May 2021, the Company received an IND approval from the NMPA to conduct phase I/II clinical trials of 302H in combination with 602 in patients with HER2 positive, KRAS/NRAS/BRAF wild-type colorectal cancers. In addition, the Company has also received an IND approval from the NMPA to conduct clinical trials of 302H in combination with IMM01, a CD47-targeting SIRP a-Fc fusion protein currently being developed by ImmuneOnco, in HER2 positive solid tumors.

Phase I development and new IND applications:

l  HIF-117 (SSS17): Phase I clinical trial of SSS17 to treat anemia patients is ongoing.

l  Anti-IL5 mAb (610): The phase Ib trial of 610 in asthma patients is enrolling patients.

l  Anti-IL4Ra mAb (611): A dose-escalating phase Ia clinical trial in healthy volunteers has been completed in the U.S. The phase Ib study in patients with AD in China’s mainland is expected to complete patient enrollment soon.

l  Anti-HER2 mAb (612): The Company has received an IND approval from the NMPA to conduct clinical trials of 612.

l  Anti-PSGL-1 mAb (617): The Company has received an IND approval from the NMPA for the treatment of advanced solid tumors.

l  Anti-PD1 x anti-HER2 bispecific antibody (705): The Company has received the IND approvals from the U.S. FDA and the NMPA.

l  Anti-PD1 x anti-PD-L1 bispecific antibody (706): The Company has received the IND approvals from the U.S. FDA and the NMPA.

In the future, the Company will continue to focus its resources on four core therapeutic areas, which are autoimmune diseases, oncology, nephrology and dermatology. Among them, the autoimmune diseases segment includes anti-IL-4Rα antibody, anti-IL-5 antibody, anti-IL-1β antibody and anti-IL-17A antibody that rank in the first R&D echelon in China’s mainland.

At the same time, the Company has further expanded its overseas partnerships. In 2021, the Company submitted an IND application to the CDE for a monoclonal antibody targeting PSGL-1 licensed from Verseau in the United States and obtained the IND approval in March 2022. At the end of 2021, the Company obtained the license of a potential first-in-class bivalent mesothelin (MSLN)-targeting CD3 T cell engager from Switzerland-based Numab. On January 4 2022, the Company entered into a licensing agreement with Syncromune Inc in the U.S. to develop and commercialize its anti-PD-1 mAb (R&D code: 609A) for use with Syncrovax™ immuno-oncology combination therapy worldwide. As part of the partnership, Sunshine Guojian is entitled to receiving hundreds of millions of US dollars in upfront payment and future regulatory and sales milestone payments and other incentives, while still holding all global rights beyond Syncrovax™, marking a milestone in out-licensing of the Company’s innovative drugs.

CDMO business had steady progress, with follow-up capacity ready to run

3SBio is one of the first companies in China to conduct contract development and manufacturing organization (CDMO) business in China. Over the past 29 years, 3SBio has established a proven track record in quality control, together with outstanding production facilities and processes. In recent years, the Company has been expanding its CDMO business to empower more biopharma companies. In 2021, the Company’s CDMO business had revenue of RMB 110 million, a year-on-year rise of 4.6%. Overseas CDMO business, including its European subsidiary Sirton and overseas customer services, contributed a higher proportion of sales, but revenue from domestic customers has risen significantly.

The CDMO business currently consists of NMV Desen Biotech Co., Ltd., Shanghai Shengguo Pharmaceutical Development Co., Ltd. and Sirton in Italy, all being the Company’s subsidiaries. Among them, Desen Biotech has a total planned area of 500 Chinese mu, designed as a biopharmaceutical CDMO base, a manufacturing base of biopharmaceutical raw and auxiliary materials and consumables, and a biopharmaceutical core process equipment base that are domestically-leading, oriented to the international market and are compliant with relevant Chinese, EU and U.S. Good Manufacturing Practice (GMP) regulations. The first phase of Desen Biotech covers an area of over 110 Chinese mu, and plans to build a production line with 199,000 liters of stock solution and a cumulative capacity of 100 million doses/year for injections. It is expected that the first phase of 76,000-liter capacity will be operational in 2022. The Group’s CDMO business has rich experience in the development of protein drug substance (DS) and drug product (DP) and the production capacity ranging from laboratory to ultra-large-scale production. It can provide customers with one-stop CDMO services covering DNA, IND, BLA and commercial production.

In the future, 3SBio will continue to expand the CDMO business by leveraging various competitive advantages, including the technological advantages associated with engaging in the whole process spanning from R&D to production of biopharmaceutical products over the years; the scalable cost advantages of a single 10,000-liter bioreactor for commercial production; the production cost advantages brought by the capability to manufacture raw materials such as culture medium and chroma-tographic filler; and the quality control management advantage with high level of automation. The Company is committed to building a comprehensive biopharma CDMO covering macromolecular biopharmaceuticals, gene therapy and cell therapy.

Dr. Jing LOU, Chairman and CEO of 3SBio, commented: “In 2021, the Group was on the right track to effectively improve operation and governance with robust performance in all four businesses, despite occasional fluctuations in the external environment. In the year, our businesses posted record growth and we brought returns to our shareholders. Looking ahead, we will continue to prioritize primary care markets and contribute to reshaping the treatment landscape for chronic diseases. We will expand and enhance our portfolio in nephrology, autoimmune diseases, as well as skin and hair health. We will also leverage external partnerships to actively seek out-licensing opportunities overseas to embrace competition and rewards in global markets. 3SBio Group aims to fulfil the unmet clinical needs, and address real needs of China’s aging population and people’s desire for a better life. We will strive to excel in delivering both social responsibility and business performance, and create greater value for our shareholders and society.”

Cautionary Note and Forward-Looking Statements

This press release contains forward-looking statements, such as those relating to business or products outlook, or Company’s intent, plans, beliefs, expectation and strategies. These forward-looking statements are based on information currently available to the Company and are stated herein on the basis of the outlook at the time of this press release. They are based on certain expectations, 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 to successfully develop or eventually launch and market such product or indication. Underlying the forward-looking statements is a large number of risks and uncertainties. Further information regarding such risks and uncertainties may be found in our other public disclosure documents. The scientific information involved may only be preliminary and empirical. Shareholders and potential investors of the Company are advised to exercise caution when dealing in the shares of the Company.