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Chinese leading biopharmaceutical company 3SBio (01530.HK) today announced its 2023 annual results.

According to its annual results announcement, revenue in 2023 increased by 13.8% year on year to approximately RMB 7.82 billion. Gross profit rose 17.1% year on year to approximately RMB 6.64 billion. Net profit attributable to owners of the parent adjusted for nonoperating items was approximately RMB 1.95 billion, a rise of 17.7% over the same period last year. EBITDA adjusted for non-operating items were approximately RMB 2.77 billion, an increase of 20.2% over the same period last year.

The board of directors of 3SBio also proposed to declare a final dividend of HKD 0.25 per share for the year ended 31 December 2023.

Core products sustain momentum, with biopharmaceuticals continuing upward trajectory

In 2023, the Company’s core biopharmaceutical products sustained strong growth and maintained their leadership in the Chinese market. Sales of TPIAO, the world’s only commercial recombinant human thrombopoietin (rhTPO) used to treat thrombocytopenia, totaled RMB 4.21 billion in 2023, a year-on-year increase of 23.8%. TPIAO has achieved a renewal in the National Reimbursement Drug List (NRDL) and it was listed with the highest-level recommendation by the Chinese Society of Clinical Oncology (CSCO) Clinical Guidelines for the Diagnosis and Treatment of Cancer Therapy Induced Thrombocytopenia (CTIT) (2022 Edition).

Sales of EPIAO and SEPO, the recombinant human erythropoietin (rhEPO), totaled RMB 940 million in 2023, representing a market share of 42.2%, according to IQVIA.

Sales of Yisaipu for the treatment of rheumatoid arthritis, ankylosing spondylitis and psoriasis were RMB 565 million, up 10.5% from the same period last year. The pre-filled aqueous injection solution of Yisaipu was approved for market launch in March, 2023.

Sales of Cipterbin for the treatment of HER2-positive metastatic breast cancer were RMB 226 million, a jump of 41.8% year on year. This product has received Level I recommendation by the Chinese Society of Clinical Oncology (CSCO) Clinical Guidelines of Breast Cancer for the treatment of patients with advanced HER2-positive breast cancer who are sensitive to anti-HER2 treatment. It has also undergone extensive real-world and expert-initiated clinical research, continuously enriching its evidence-based profile.

Hair health portfolio sees enrichment, with Mandi occupying a 72.6% market share

Mandi, an over-the-counter (OTC) solution for androgenic alopecia and alopecia areata, sustained its rapid growth trajectory. In 2023, Mandi’s sales reached RMB 1.12 billion, marking a year-on-year rise of approximately 25.8%. According to the Chinese Pharmaceutical Association, Mandi boasted a share of 72.6% of the minoxidil market in the Chinese mainland. In 2023, efforts were dedicated to solidifying Mandi’s stature as a strong hair health brand, alongside expanding its digital marketing infrastructure to enhance visibility across e-commerce platforms. Moreover, the approval of Mandi foam product is poised to strengthen its competitive advantage in the market.

CDMO business chalks up new milestone

In 2023, the Company’s CDMO business continued to scale up, with revenue of approximately RMB 174 million, a year-on-year increase of 4.9%. The CDMO signed orders valued at more than RMB 200 million, including partnerships with leading Chinese and overseas pharmaceutical companies and biotech companies. Shenyang Desen Biologics’s production capacities, totaling 76,000 liters of Drug Substance (“DS”) and Drug Product (“DP”), has been undergoing gradual validation since 2023.

Development of pipelines in full swing

According to the report, 3SBio had 29 product candidates within the active pipeline. Among them, there were 13 product candidates in hematology/oncology, 11 product candidates for auto-immune diseases and ophthalmology, 4 product candidates in nephrology and 1 product candidate in dermatology. Up to now, 12 candidates have been advanced to the clinical phase III or NDA-enabling phase, and 3 generic candidates are in the BE- and ANDA-enabling phase.

In 2023, several 3SBio products were approved for commercial launch. Among them, the prefilled injection of Yisaipu provides patients with an easy-to-use option and significantly improves the convenience of administration. Remitch (nalfurafine hydrochloride orally disintegrating tablets) is approved for the treatment of pruritus in dialysis patients. The IND for the phase III clinical trial has been approved for treating pruritus in patients with chronic liver disease (only in cases where the efficacy of existing treatments is not desirable), and the NDA is expected to be filed within this year. In addition, minoxidil foam catering to individuals with sensitive scalps was approved for launch on January 8. The phase III clinical trial of long-acting EPO (SSS06) for treating anemia in patients with chronic renal failure met its primary endpoint, with plans for an NDA submission within the year.

The pipeline for auto-immune diseases is on track to embrace a fruitful phase. In 2023, the phase III clinical trial of anti-IL-17A mAb (608) for the treatment of plaque psoriasis met its primary endpoint, with plans for a BLA submission within this year. The phase II clinical trials of anti-IL-1β mAb (613) for the treatment of acute gouty arthritis and anti-IL-4Rα mAb (611) for the treatment of atopic dermatitis, chronic sinusitis with nasal polyps and moderate to severe chronic obstructive emphysema met the primary endpoints, and patient enrollment for the phase III clinical trials has been completed. The primary endpoint data were obtained in the phase II clinical trial of the anti-IL-5 antibody (610) for the treatment of severe eosinophilic asthma.

In 2023, 3SBio made significant strides in its external collaborations. The phase III clinical trial of Nofazinlimab, an anti-PD-1 monoclonal antibody developed in partnership with CStone Pharmaceuticals, was advancing actively. Leveraging 3SBio’s extensive expertise in developing and registering antibody drugs, along with its high-quality, cost-effective production capabilities and seasoned oncology commercialization team, this product is expected to be a novel, effective first-line treatment for patients with advanced hepatocellular carcinoma. Moreover, the bridging clinical trial for Winlevi, a clascoterone cream developed in collaboration with Cosmo Pharmaceuticals for acne treatment, has received approval from the National Medical Products Administration. As the first acne medication with a new mechanism of action approved by the FDA in 40 years, Winlevi has been widely recognized by dermatologists in the U.S., and prescribed by 15,000 doctors since its launch in December 2021, with more than 670,000 prescriptions in total, making it the most prescribed acne medication in the U.S. Spearheaded by 3SBio, Winlevi is poised to offer new therapeutic avenues for millions of acne patients in China.

Moving forward, 3SBio will continue to focus on the fields of its strength, namely nephrology, autoimmune diseases, dermatology , hematology and oncology. The Company will accelerate the clinical development of candidates for autoimmune diseases with leading positions in China’s mainland. 3SBio will leverage both in-house research and development and external partnerships, actively exploring potential targets for collaboration to supplement its existing portfolio. The Company will also capitalize on its established capabilities on biopharmaceutical R&D and registration, commercial production and sales to bring forward more high-quality innovative pharmaceuticals to the market.

Dr. Jing LOU, Chairman and CEO of 3SBio, commented: “Over the past year, our 3SBio team has worked closely together to navigate a dynamic industry landscape, overcoming challenges and seizing opportunities to achieve remarkable growth for all businesses. We’re thrilled to witness the continual introduction of new products, offering patients enhanced treatment options. We anticipate our pipeline products to unleash their potential so as to further fuel our growth. Meanwhile, we will leverage our comprehensive platform strengths to empower biotech firms in China and overseas. Moving forward, 3SBio will remain steadfast in its role as a national biopharmaceutical leader, leveraging its experience and passion to advance pharmaceutical development. We will build a strong foundation for corporate growth, drive industrywide progress, advance high-quality industry development, and play our part in fostering a Healthy China.”