On August 26, 2021, Simcere Pharmaceutical Group Co., Ltd. (HKEX: 2096) released announcement of 2021 Interim Results.
In the first half of 2021, the company achieved revenue of RMB 2.12 billion，an increase of approximately 10.1% as compared to the same period last year.
Revenue from innovative drugs was RMB 1.22 billion, accounting for 57.6% of the total revenue for the same period, setting a historic high (the percentage of revenue from innovative drugs in comparison to total revenue for 2018, 2019 and 2020 were 25.5%, 32.9% and 45.1%, respectively).
The company’s R&D cost was RMB 627 million, an increase of 38.0% over the same period last year.
The profit was RMB 555 million, an increase of 200.2% over the same period last year.
Among the revenue of innovative drugs, strong growth is seen from the sales of Sanbexin®, Simcere’s core Central Nervous System（CNS）product launched in July 2020. At the same time, the innovative drug R&D, which consists of nearly 60 projects in its pipeline, progressed rapidly. In the past 6 months, 5 projects had entered the pivotal phase III clinical trial.
Simcere continued to apply a “dual-drive" model of innovation, which combined in-house R&D with international collaborations. In March, Simcere signed a strategic partnership with Kazia Therapeutics to obtain rights to develop and commercialize neurology products in Greater China. In June, a partnership was clinched with Vivoryon Therapeutics for oncology product development.
All these reflect a rapid and steadfast transition of Simcere towards an innovation and R&D-driven pharmaceutical company
Sanbexin® sees strong growth in its first year on the market, targeting leadership in the CNS field
Simcere’s 2021 interim results showed that the CNS drug portfolio (Sanbexin® and Bicun® are two major products in this portfolio) reached RMB 595 million, accounting for 28.1% of the total revenue. Sanbexin® had contributed a dominating share in this category.
Sanbexin® is a category I innovative drug developed by Simcere with proprietary intellectual property right. According to Frost & Sullivan, it is the only drug used in the treatment of stroke to obtain approval for sale in the past five years worldwide. In less than 5 months, Sanbexin® was included in the Drugs Catalogue for the National Basic Medical Insurance, Work-related Injury Insurance and Maternity Insurance (“NRDL”) (2020) on December 28 2020. It was the fastest innovative drug to be entered into NRDL in the year. On March 1, 2021, the NRDL officially went into effect.
As of June 30, 2021, Sanbexin® has been sold to 30 provinces, municipalities and autonomous regions across the country, covering approximately 1,500 medical institutions.
Meanwhile，Sanbexin sublingual tablets, the solid dosage form of edaravone dexborneol, is at Phase III clinical stage. Sequential therapy consisting of Sanbexin sublingual tablets and edaravone and dexborneol concentrated solution for injection is designed to enable patients to receive a timely and complete treatment. The administration of sublingual tablets is less dependent on medical facility conditions or compliance of patients, which makes it more suitable for research on new indications such as other chronic central nervous system diseases.
The addition of sublingual tablets to the portfolio in the future will further position Sanbexin® as a leader in the market of drugs for treatment of CNS diseases.
The "Innovation Index" has improved remarkably
During the first half of 2021, revenue derived from sales of innovative drugs was RMB 1,220 million yuan, contributing to 57.6% of total revenue for the same periods, whereas the average ratio of companies of its kind in the industry was 13% (data from IQVIA).
During the six months ended June 30, 2021, R&D investment amounted to approximately RMB 627 million, accounting for approximately 29.6% of the revenue, representing an increase of approximately RMB 173 million or 38.0% as compared to the same period of 2020.
These indice set a historic high for Simcere and showed Simcere’s rapid transition towards an innovation-driven company.
In the first 6 months of 2021, R&D projects in Simcere’s pipelines had seen tremendous progress. 7 IND approvals (with the Clinical Trial Approval received) and the first subject enrollment for 7 trials were completed.
Currently, Simcere has nearly 60 innovative pharmaceutical projects in pipeline. Among them, 11 innovative pharmaceutical products were at the stage clinical study.
During the six months this year, 6 studies were in the stage of phase III clinical trials, namely Sanbexin sublingual tablets (for acute ischemic stroke), Trilaciclib (for SCLC, CRC and TNBC), recombinant human endostatin for new indications (thoracoabdominal effusions) and Sevacizumab (for ovarian cancer), the latter 5 of which were newly added in the first half of 2021.
1 sutdy were in the stage of phase II clinical trials, namely iguratimod tablets for new indications (for Sjogren’s syndrome).
5 products were in the stage of phase I clinical trials, namely SIM0201 (for solid tumor), pegylated recombinant human endostatin for injection (for solid tumor), SIM0335 (for psoriasis), SIM0295 (for gout with hyperuricemia), SIM0307 (stroke with cerebral edema); the latter one, SIM0307, was added in the first half of 2021. In addition, on July 29, 2021, the Group recorded a new phase II clinical study for Envafolimab in combination with Sevacizumab (for solid tumor).
Currently, the company has an R&D team of approximately 900 staff and three R&D centers located in Shanghai, Nanjing, the PRC and Boston, the United State. The company is expected to maintain frequency of new product launch at minimum once every year from 2021.
Forward Looking Statements
Information set forth in this press release contains forward-looking statements, which involve a number of known and unknown risks, uncertainties and assumptions. The forward-looking statements contained herein reflect the current judgment and views of Simcere Pharmaceutical Group Limited as of the date of this press release. Such forward-looking statements are neither promises nor guarantees but are subject to a variety of risks and uncertainties, many of which are beyond our control, or may not materialize, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any such statements, whether as a result of new information, future events or otherwise, to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based.