A pivotal phase Ⅱ clinical study, led by Professor Lin Shen from Peking University Cancer Hospital and Institute，has evaluated the efficacy and safety of Envafolimab in patients with advanced dMMR/MSI-H tumors. The updated clinical data presented at CSCO 2021 showed that the Objective Response Rate (ORR) of patients who received Envafolimab as second or later-line treatment is 44.7%, including 12 (11.7%) cases of Complete Response (CR). The responses were durable, and the rates of durable response at 12 months in patients with advanced colorectal cancer (CRC), advanced gastric cancer, other advanced solid tumors, and all patients were 89.3%, 100%, 100%, and 93.2%, respectively. The median progression-free survival (PFS) was 11.1 months, 12-month overall survival (OS) rate was 73.6%. Envafolimab was well tolerated in this study with no cases of immune-related pneumonitis, immune-related colitis, immune-related nephritis, or infusion related reactions reported.

At present, Envafolimab is being studied in clinical trials in multiple tumor types in China, the United States and Japan, including registration/phaseⅢclinical trials in multiple indications. Envafolimab obtained orphan drug designation from the US FDA for the treatment of advanced biliary tract cancer and soft tissue sarcoma.

It is the first listed class I anti-tumor drug in the world, with patents from China and the United States. In addition, it has won the second prize of National Technological Invention Award and China Patent Gold Award, and has been listed in the National Medical Insurance Catalog since 2017.

Platinum-based agents exert the function by binding to DNAs to interfere with their replication, thereby preventing the division and growth of tumor cells. As a second-generation platinum-based agent, nedaplatin is more dissoluble in water and appears to be less toxic to the kidneys and the digestive system, and therefore more suitable for elderly patients as well as patients with renal insufficiency.

Pemetrexed is a multi-targeted anti-folate agent with low toxicity and broad-spectrum anti-tumor activity. Pemetrexed combined with platinum is a therapy recommended by NCCN guidelines and CSCO guidelines for the first-line and maintenance treatment of advanced non-squamous NSCLC and advanced malignant pleural mesothelioma (MPM), which can significantly improve the efficacy of traditional chemotherapy and prolong the survival of patients.

It is used as the recommended agent for the chemotherapy of gastrointestinal cancer operation and is considered highly effective in reducing recurrence risks as well as improving prognosis of patients with digestive system tumors.

As a cornerstone drug for the treatment of multiple myeloma, Bortezomib is used throughout the induction, consolidation and maintenance therapies for myeloma. In 2020, Bortezomib was recommended as a first-line drug for the full management of multiple myeloma in the Guidelines for Diagnosis and Treatment of Multiple Myeloma in China and was included in the NDRL.

The only bendamustine approved for indication of both CLL and B-cell NHL in China currently. In 2020, guidelines published by the Chinese Society of Clinical Oncology (CSCO) and National Comprehensive Cancer Network (NCCN) have recommended bendamustine as the first- and second- line treatment of multiple subtypes of B-cell lymphoma.

As a national class I innovative drug, Sanbexin^® can improve the neurological function of patients with strokes by inhibiting the dual mechanisms of oxidative stress damage and inflammatory damage. Sanbexin^® owns eight patents, with core patents authorized in the US, Japan and European countries and regions. It has received national special support for "Significant New Drug Development" and been awarded as one of “China’s Milestone Medical Achievements During the 13th Five-Year Plan Period”.

As the first edaravone solution for injection marketed in China, BICUN^® is a representative pharmaceutical of free radical scavengers and anti-oxidant. It can improve the neurological function of stroke patients, and delay the progression and deterioration of amyotrophic lateral sclerosis.

Trazodone can relieve sleep disorders caused by SSRIs, and is often used as an adjunctive therapy for SSRIs. In addition, Trazodone can prolong the deep sleep, improve sleep quality, induce and maintain deep sleep, and alleviate anxiety and sexual dysfunction.

IREMOD^® is the first iguratimod approved for sale in the world and the only iguratimod approved for sale in China. It is also the only domestically-developed small molecule DMARD that was marketed over the past decade. IREMOD® has been recommended as the primary medication for treatment of active rheumatoid arthritis by multiple clinical practice guidelines and diagnosis criteria at home and abroad.

AIJIEWEI^® has passed consistency evaluation and entered the fourth national VBP. It blocks the JAK signal pathway by intracellular targeting and regulates various inflammatory factors associated with Ra, achieves potent and rapid improvement of traditional DMARDs in rheumatoid arthritis patients with poor efficacy, and is recommended by Chinese and International Authority RA guidelines.

With its unique sustained-release pellet technology, YINGTAIQING^® proves effective within one hour and the action can last up to 12 hours, ensuring fast and effective pain relief. It currently has both dosage forms of capsule and gel.

RUIFUSHU is the first nephrology product by Simcere, and has passed the consistency evaluation. It has been recommended by numerous domestic and international guidelines as the first-line treatment for preventing rejection following organ transplantation.

In December 2019, mycophenolate mofetil was approved for the treatment of class III-IV lupus nephritis of adult patients. This indication was included in the new National Reimbursement Drug List (NRDL), updated in March.

In addition, mycophenolate mofetil can also be used to treat other autoimmune diseases such as systemic lupus erythematosus (SLE), dermatomyositis, scleroderma, IgA nephropathy, membranous nephropathy (MN) and Nephrotic syndrome (NS).

As an exclusive production in the Chinese pharmaceutical market, OLMETEC PLUS^® is a new-generation compound preparation of an angiotensin II receptor blocker, olmesartan medoxomil, and a thiazide diuretic, hydrochlorothiazide. Developed and manufactured by Daiichi Sankyo, its commercialization right on the Chinese market is entitled to Simcere.

As a third-generation statin, it has been listed into a number of clinical practice guidelines in China as a recommended medication for dyslipidemia.

It is a long-lasting anti-hypertensive drug. It can be metabolized by the liver, and proves protective for the kidneys.

XINSHIPING is the second calcium channel blocker (CCB) that has adopted controlled release technology and passed the consistency evaluation in China. The drug is released at a uniform rate over 24 hours through the laser hole in the outer protective film of the tablet, avoiding the phenomenon where plasma concentration peaks and drops drastically, ensuring a stable and long-lasting hypotensive effect.

Biapenem is a carbapenem antibiotic that can exert antibacterial effects by inhibiting the synthesis of bacterial cell walls, with broad-spectrum antibacterial activity against Gram-positive and Gram-negative aerobic and anaerobic bacteria. Biapenem is stable to human kidney dehydropeptidase-I (DHP-I) and can be administered alone without combination with DHP-I inhibitors.

Arbidol is a hemagglutinin fusion inhibitor and proves to be effective against viruses resistant to neuraminidase inhibitors. It is a broad-spectrum anti-viral agent for the treatment of influenza.

Zanamivir is recognized as one of the only two antiviral drugs effective against H1N1 influenza virus. YEQING^® is the only Zanamivir with NMPA production approval in China for the treatment of H1N1 influenza.

Amoxicillin mainly acts in the reproduction stage of microorganisms and inhibits the biosynthesis of cell wall mucopolypeptides. Potassium clavulanate can inactivate these enzymes produced by most bacteria by blocking the active site of β-lactamase. ANQI^® produced by our company has two dosage forms—tablets and granules.

Amoxicillin is a type of semi-synthetic penicillin β-lactam antibiotic. It has several dosage forms—capsules, dispersible tablets and granules.

It is the first Cefaclor suspension which has passed consistency evaluation for generic drugs in China, and is listed into the recommended medications by the Guidelines for the Treatment of Community-Acquired Pneumonia in China.

This product contains two dosage forms—granules and capsules. LIHONG^® is a second-generation cephalosporin product with broad antibacterial spectrum activity and little adverse effects. In addition, it is an oral antibiotic recommended by the US FDA for the treatment of otitis media and sinusitis in children, and is clinically recognized as the first choice medication for community- acquired pneumonia.

Cinacalcet (calcimimetic) inhibits the secretion of parathyroid hormone by binding to the transmembrane domain of calcium receptors on the surface of parathyroid cells and transferring calcimimetic signals to the cells. It is currently the only calcimimetic that significantly lowers PTH/calcium/phosphorus/calcium-phosphorus product in China, and is the first-line drug recommended by a number of domestic and foreign guidelines (2017 version of KDIGO guideline, 2019 version of China CKD-MBD guideline).

By physical action, BIQI^® montmorillonite powders can physically cover the surface of the gastrointestinal tract, and adsorb pathogenic factors, so as to quickly solve various diarrhea problems, without the need to enter the blood circulation, therefore being safe and non-toxic. Its prescription and preparation technique have obtained EU GMP certification and are now available in China and Europe.

As the second generation of 5-HT3 receptor antagonists, it have strong affinity to receptors and long time of drug action.

This product is derived from Maxingshigan Decoction by Doctor Zhang Zhongjing. The Diagnosis and Treatment Protocol for COVID-19 (Trial Version 4) listed Maxingshigan Decoction as one of the recommended prescriptions.

The key to calcium supplementation is absorption, and the key to absorption is to ensure the absorbing of active vitamin D. The main ingredient of FANENG^® is active vitamin D, which is used to treat osteoporosis, and can effectively promote the absorption of calcium and reduce the incidence of hypercalcemia.

Aldioxa Tablets can promote the regeneration of granulation tissue and mucosal epithelium, improve mucosal blood flow, and promote the healing of ulcers.

DING'AN^® hydrotalcite chewable tablets can quickly and effectively relieve a variety of discomfort symptoms in the stomach, and protect the gastric mucosa from damage.