According to the PDB drug comprehensive database, the total sales of the sample hospital market in 2021 will reach 235.7 billion yuan, of which about 100 varieties have newly entered the market, contributing 120 million yuan in sales. Among these new drugs on the market, there are many domestic class 1 innovative drugs and imported new drugs that are urgently needed in clinical practice, and they have shown a good sales trend in the hospital market.
Cyclopofol (ciprofol) is a gamma-aminobutyric acid A (GABAA) receptor agonist and is an anesthetic sedative. In December 2020, the State Food and Drug Administration approved the listing of a Class 1 innovative drug Cyclopofol Injection (trade name: Sishuning) of Liaoning Haisco Pharmaceutical Co., Ltd. for sedation in gastrointestinal endoscopy. Cyclopofol has a similar pharmacological mechanism to propofol, a commonly used clinical anesthetic and sedative drug, but has the advantages of fast onset of action, less injection pain, mild respiratory depression, and rapid recovery.
Cyclopofol injection entered the sample hospital market in the first quarter of 2021, and achieved annual sales of 21.252 million yuan, quarterly: 32,000 yuan, 876,000 yuan, 7.646 million yuan, and 12.699 million yuan. In 2021, the sales of propofol emulsion injection and propofol medium/long-chain fat emulsion injection will be 800 million yuan and 288 million yuan respectively.
Inetetab is an ErbB-2 antagonist, a genetically engineered version of trastuzumab. In June 2020, Initumumab for injection (trade name: Cypritine) produced by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. was approved by the State Food and Drug Administration for marketing in combination with chemotherapy for the treatment of HER2-positive metastatic disease. breast cancer. Initumumab has been included in the "2021 Chinese Society of Clinical Oncology (CSCO) Breast Cancer Diagnosis and Treatment Guidelines" and "Chinese Anti-Cancer Association Breast Cancer Diagnosis and Treatment Guidelines and Specifications (2021 Edition)", and has become the guideline for the whole course of anti-HER2 treatment for advanced breast cancer patients. basic medicines.
Initumumab for injection entered the sample hospital market in the first quarter of 2021, with sales of 527,000 yuan, 3.475 million yuan, 5.039 million yuan, and 6.389 million yuan in the four quarters, totaling 15.422 million yuan for the whole year.
Venetoclax is a first-in-class, oral, selective B-cell lymphoma factor-2 (Bcl-2) inhibitor developed by AbbVie in collaboration with Roche. Veneclax selectively inhibits the function of Bcl-2, restores the communication system of cells, allows cancer cells to self-destruct, and achieves the purpose of treating tumors. Venclexta was first marketed in the U.S. in April 2016 under the trade name Venclexta and is now approved in more than 80 countries worldwide for the treatment of chronic lymphocytic leukemia (CLL), small cell lymphoma (SLL), acute myeloid lineage leukemia (AML). In the United States, veneclax has been granted 6 breakthrough therapy designations by the FDA, one for first-line treatment of CLL, two for first-line treatment of relapsed or refractory CLL, two for first-line treatment of AML, and one for myelodysplastic syndrome disease (MDS). According to AbbVie, Venclexta's global sales in 2021 will be $1.82 billion, an increase of 36.1% from the previous year.
In December 2020, Venclexta tablets (trade name: Venclexta/Venclexta) were approved for import by the State Food and Drug Administration, combined with azacitidine for acute myeloid leukemia (AML) intolerant of strong induction chemotherapy. The first Bcl-2 inhibitor approved in China.
Venekla tablets will enter the sample hospital market in the second quarter of 2021, with Q2-Q4 sales of 3.218 million yuan, 4.616 million yuan, and 4.858 million yuan, totaling 12.692 million yuan.
Siponimod is a sphingosine-1-phosphate (S1P) receptor modulator that selectively binds to S1P receptor subtype 1 (S1P1) and subtype 5 (S1P5) with high affinity, preventing lymphatic The cells escape from the lymph nodes, reducing the number of lymphocytes in the peripheral blood. Sinimod was developed by Novartis and was first launched in the United States in April 2019 under the trade name Mayzent. Siponimod is the world's first and only oral disease-modifying drug approved for the treatment of active secondary progressive multiple sclerosis (SPMS). Early initiation of treatment can effectively slow the progression of disability and cognitive decline in patients . According to Novartis, Mayzent's global sales in 2021 will be $281 million, an increase of 65.0% from the previous year.
In May 2020, Sinimod tablets (trade name: Wanlineng/Mayzent) were approved for import by the State Food and Drug Administration for the treatment of adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease and Active secondary progressive disease.
Sinimod tablets will enter the sample hospital market in the first quarter of 2021, with sales of 754,000 yuan, 2,047,000 yuan, 3,458,000 yuan, and 4,198,000 yuan in the four quarters, totaling 10,456,000 yuan for the whole year.
Amphotericin B cholesterol sulfate complex
Amphotericin B (amphotericin B) belongs to the polyene antibiotics, and is one of the most powerful and broad antibacterial spectrum drugs for the prevention and treatment of invasive fungal diseases. At the end of March 2021, the Amphotericin B Cholesterol Sulfate Compound for Injection of CSPC Ouyi Pharmaceutical Co., Ltd. was approved by the State Food and Drug Administration for listing, which is the first imitation of this variety in China. It is used for patients suffering from deep fungal infections. Patients, patients who are unable to take effective doses of amphotericin B due to renal impairment or drug toxicity, or patients who have received amphotericin B therapy that has not responded. Compared with the current domestic clinical use of amphotericin B for injection, the product can significantly reduce nephrotoxicity, increase the dosage, thereby improving the therapeutic index.
Amphotericin B Cholesterol Sulfate Compound for Injection entered the sample hospital market immediately after it was approved. In 2021, the sales of amphotericin B for injection and amphotericin B liposome for injection will be 39.55 million yuan and 31.43 million yuan respectively.
Ensatinib is a novel potent and highly selective next-generation anaplastic lymphoma kinase (ALK) inhibitor. In November 2020, the State Food and Drug Administration approved Betta Pharmaceuticals Co., Ltd.'s Class 1 innovative drug Ensatinib Hydrochloride Capsules (trade name: Bemena) with conditions for the listing of previously received crizotinib therapy Treatment of patients with post-progressed or crizotinib-intolerant anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). Compared with the first-generation ALK inhibitor crizotinib, ensatinib binds more strongly to ALK and also exhibits strong inhibitory activity against crizotinib-resistant mutants.
Ensatinib hydrochloride capsules will enter the sample hospital market in the second quarter of 2021. The sales of Q2-Q4 are: 604,000 yuan, 2.223 million yuan, and 2.016 million yuan, totaling 4.842 million yuan. In 2021, the sales of crizotinib capsules will be 325 million yuan.
Pomalidomide is a thalidomide analog developed by Celgene (which has been acquired by Bristol-Myers Squibb). Immunomodulators for myeloma (MM). Pomalidomide was approved by the US FDA in February 2013 and the EU in August of the same year. Pomalidomide can effectively treat multiple myeloma using very low doses, thereby reducing the risk of adverse events. Pomalidomide responds well to multiple myeloma that is refractory to lenalidomide and thalidomide. According to Bristol-Myers Squibb, global sales of Pomalyst/Imnovid in 2021 will be US$3.332 billion, an increase of 9.0% from the previous year.
In November 2020, the first imitation product of Chia Tai Tianqing Pharmaceutical Group Co., Ltd., pomalidomide capsules, was approved by the State Food and Drug Administration for marketing, and it was used in combination with dexamethasone for at least two previous treatments (including lenadol amine and a proteasome inhibitor) and who had disease progression during or within 60 days of their last treatment.
Chia Tai Tianqing's pomalidomide capsules entered the sample hospital market in the first quarter of 2021, with sales of 689,000 yuan, 915,000 yuan, 1.913 million yuan, and 1.313 million yuan in the four quarters, totaling 4.829 million yuan for the whole year.
Ertugliflozin is a sodium-glucose co-transporter 2 (SGLT-2) inhibitor jointly developed by Pfizer and Merck. It was approved by the US FDA in December 2017 and approved by the EU EMA in January 2018. . Itogliflozin is the fourth SGLT-2 inhibitor approved by the FDA.
In July 2020, itogliflozin tablets (trade name: Steglatro/Steglatro) were approved for import by the State Food and Drug Administration to improve blood sugar control in adults with type 2 diabetes in combination with diet and exercise.
Atogliflozin tablets entered the sample hospital market in the first quarter of 2021, with sales of 39,000 yuan, 283,000 yuan, 1.132 million yuan, and 2.649 million yuan in the four quarters, totaling 4.102 million yuan for the whole year. In 2021, the sales of the other three SGLT-2 inhibitors listed in China are: dapagliflozin tablets of 450 million yuan, empagliflozin tablets of 81.09 million yuan, and canagliflozin tablets of 49.97 million yuan.
Deutetrabenazine, a derivative of tetrabenazine, uses deuterated technology that gives the active ingredient a favorable pharmacokinetic profile, allowing for less frequent dosing while significantly improving the drug's safety profile and effectiveness. Deuterotetrabenazine was developed by Teva and was first listed in the United States in April 2017. According to Teva, Austedo’s 2021 sales will be $802 million, an increase of 26.0% from the previous year.
In May 2020, Deuterotetrabenazine Tablets (trade name: Antaitan/Austedo) was approved for import by the State Food and Drug Administration, and is the first drug in China for the treatment of chorea and tardive dyskinesia related to Huntington's disease.
Deuterotetrabenazine Tablets entered the sample hospital market in the first quarter of 2021. The sales in the four quarters were 144,000 yuan, 767,000 yuan, 962,000 yuan, and 1.547 million yuan respectively, with a total of 3.42 million yuan for the whole year.
Cenegermin is a novel recombinant human nerve growth factor (rhNGF) that is structurally identical to the nerve growth factor (NGF) protein produced in the human body and contained in ocular tissue. Senegiamine was developed by Dompe and was approved by the EU EMA in July 2017 and the US FDA in August 2018. Neurotrophic keratitis is a rare degenerative corneal disease that can cause blindness. The surgical treatment of moderate to severe neurotrophic keratitis is an invasive procedure with high cost and no permanent cure. effective therapeutic drugs.
In August 2020, Senecimine eye drops (trade name: Oxervate) was approved for import by the State Food and Drug Administration for moderate (persistent corneal epithelial defect) to severe (corneal ulcer) neurotrophic diseases in adults Keratitis is the first product of its kind in China.
Senaijiming eye drops entered the sample hospital market in the first quarter of 2021. The sales in the four quarters were 662,000 yuan, 515,000 yuan, 736,000 yuan, and 1.508 million yuan respectively, with a total of 3.420 million yuan for the whole year.
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