Simcere Pharmaceuticals Announcement of Mid-2021 Results: Increased R&D Investment and Accelerated Innovation and Transformation

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On August 26, Simcere Pharmaceutical Group Co.

Simcere’s R&D strategy continues to focus on three therapeutic areas, namely tumors, central nervous system and autoimmune system, and develops products that cover both small molecule chemical drugs and macromolecular biological products

Simcere's product pipeline under development (Source: Simcere's official website)

The central nervous system pipeline accounts for the largest proportion of revenue, and innovative drugs must first contribute the most to new ones

Stroke is one of the main central nervous system diseases and also an important fatal disease.

Huge unmet clinical needs and lack of new drugs have always been an "embarrassment" in the field of stroke treatment

The central nervous system, which focuses on stroke, has always been the top priority of Inception

Bicun (edaravone injection) is another blockbuster drug in the central nervous field of Simcere

Simcere’s interim results report shows that: the central nervous system disease drug portfolio (main products must be new and must be stored) revenue reached 595 million yuan, accounting for 28.

In addition to having to be new and paving the way for the market, the Y-2 sublingual tablet, which is under research, acts as a potential growth driver in the central nervous field of the first sound

The combination of self-research and license-in, the tumor field is a potential direction for follow-up efforts

The incidence of cancer in China is increasing.

Source: Frost & Sullivan analysis, Simcere's prospectus

Simcere Pharmaceutical has deployed many innovative drug products in the oncology field through independent research and development and introduction

There are currently six anti-tumor drugs in the research and development stage, including bevacizumab biosimilars in cooperation with Amgen, and a new generation of recombinant humanized anti-vascular endothelial growth factor monoclonal antibody seval jointly developed with Apexigen.

Among them, the CDK4/6 inhibitor Trilaciclib also shows different advantages from other drugs with the same target

It is a highly effective, selective and reversible inhibitor of cyclin-dependent kinase 4 and 6 (CDK4/6), which can temporarily block hematopoietic stem and progenitor cells in the bone marrow in the G1 phase of the cell cycle, thereby protecting Bone marrow cells are protected from damage by cytotoxic chemotherapy

In addition, Servacizumab is an innovative vascular targeting drug jointly developed by Simcere and Apexigen.

Commercialization of three products in the field of self-immunity

Autoimmune diseases are mainly caused by the immune system mistakenly attacking the body's own tissues and organs

Based on China's population base and the high incidence of autoimmune diseases, with the continuous advancement of diagnostic technology, the launch of many autoimmune drugs, and the continuous increase of national income, the market demand for autoimmune disease drugs in China will grow rapidly

Source: Frost & Sullivan analysis, Simcere's prospectus

Adexin (Iramod tablets) is the world’s first Iramod drug approved for marketing and the only Iramod drug approved for marketing in China.
It has been included in the National Medical Insurance Catalogue since 2017 and has been used by many clinicians.
The practice guide recommends it as the main therapeutic drug for the treatment of active rheumatoid arthritis, and the market share is among the top three in the country; according to Frost & Sullivan, the traditional synthetic anti-rheumatic drug market in China from 2015 to 2019 in terms of sales revenue The compound annual growth rate is 12.
4%, reaching RMB 3.
1 billion in 2019, and is expected to increase to RMB 5.
8 billion in 2024
.
Among them, Iramod ranks third among traditional synthetic anti-rheumatic drugs, with a market share of 18.
4%
.

Enrico (Abatacept injection) is the first and only CTLA4-Fc fusion protein approved for sale in China, and is currently the only T cell selective costimulatory immunomodulator in the field of autoimmune diseases
.
It was introduced by Simcere Pharmaceuticals from Bristol-Myers Squibb (BMS) in 2013 and is responsible for clinical development and commercialization in mainland China.
It has been officially launched and commercialized in August 2020
.

Aijiewei (tofacitib citrate tablets) is the third product launched by Simcere in the field of rheumatoid treatment after Edsine and Enrico
.
The original drug is a Janus kinase (JAK) inhibitor developed by Pfizer.
It is clinically mainly used to treat adult patients with moderate to severe active rheumatoid arthritis
.
In November 2012, it was approved by the FDA for listing; in March 2017, it was approved by the national drug regulatory authority to enter China
.

In the "2018 Chinese Rheumatoid Arthritis Diagnosis and Treatment Guidelines", tofacitib has the same status as TNFα inhibitors and tocilizumab.
In 2019, it entered the national medical category B catalog through negotiations
.
Simcere IJV was approved for listing on August 16, 2020, and entered the centralized procurement catalog with a price cut on August 20
.
As a new member of Simcere’s product portfolio in the field of rheumatism, the launch of this product will still help Simcere’s sales growth in this field
.

In addition, Simcere is also developing the innovative small molecule drug SIM-295 for the treatment of gout with hyperuricemia, and the innovative small molecule drug SIM-335 for topical treatment of patients with mild to moderate plaque psoriasis.
Currently in preparation for phase I clinical trials
.

R&D continues to increase, innovation and transformation speed up

In the first half of 2021, Simcere announced that its semi-annual research and development costs reached 627 million yuan, an increase of approximately 38.
0% over the same period last year
.
R&D investment accounts for approximately 29.
6% of operating income
.
Looking back, the company’s R&D investment ratio in recent years has always been at a high level in the industry: from 14.
2% in 2019, to 25.
3% in 2020, and then close to 30% in the first half of 2021, it can be said that it peaked after the IPO
.
Compared with the industry, the average proportion is less than 10% (excluding unprofitable biotech companies), and 30% of the investment courage is remarkable among Chinese pharmaceutical companies
.

Internal R&D capabilities are one of the core driving forces of innovation and transformation
.
By improving the drug discovery technology platform, optimizing the R&D management process, and expanding the scale of R&D personnel, the company actively explores innovation opportunities in the three core therapeutic areas
.
Under the guidance of the innovation and transformation strategy, Simcere's continued increase in R&D investment is about to usher in a phased harvest period
.
In the next few years, it is expected that innovative drugs will be submitted for marketing applications one after another.
Simultaneously, Simcere will advance clinical research and submit clinical trial applications at different stages at the rate of multiple products each year
.
Such a stride of commercialization will undoubtedly enhance Simcere’s innovative drug product portfolio and market penetration in the three major therapeutic areas, and the advancement of pipeline projects will also bring the team’s experience and knowledge enhancements, and enable the company’s pace of innovation.
More calm
.

Mr.
Ren Jinsheng, Chairman and CEO of Simcere Pharmaceuticals, stated that Simcere was mainly engaged in generic drug business in the past.
Starting from this semi-annual report, Simcere is a pharmaceutical company dominated by innovative drug business
.

In summary, after years of accumulation and deployment, Simcere has established a diversified and certain leading product portfolio in the three therapeutic areas of tumor diseases, central nervous system diseases, and autoimmune diseases.
There are currently more than 50 pipelines.
Products will continue to provide fresh blood for subsequent development
.

At present, from the perspective of R&D investment and clinical trials, Simcere is stepping up its efforts to promote the implementation of innovative products in its pipeline, and has begun to explore opportunities for external cooperation in innovative internal projects with world-renowned biomedical companies.
In practice Continuously improve and take the pace of international research and development
.
With a comprehensive strategic layout and product portfolio thinking, as well as deep clinical resources and commercialization capabilities, we have reason to believe that Simcere is welcoming the next harvest period
.