Editor's Notes: New drugs in this article refer to
Innovative/improved new chemical drugs / biological products that have never been granted marketing authorization in or outside China;
Original/improved chemical drugs / biological products that have received marketing authorization outside China and are applying for marketing authorization in China;
First generic drugs in China*.
*"First generic drug in China" refers to the first generic drug developed by a Chinese company and approved by China National Medical Products Administration (NMPA) with marketing authorization.
In Apr. 2021, China National Medical Products Administration (NMPA) approved a total of 12 new drugs. Among them, eight are therapeutic biological products and the other four are chemical drugs. Details are listed as follows.
1. Takeda's Patent Drug Icatibant Receives Marketing Authorization
Generic name | Icatibant Injection |
Brand name | Firazyr |
Classification | Chemical drug |
Time from application submission to approval | 307 days |
Approval date | Apr. 7, 2021 |
Priority review & approval | No |
MAH (marketing authorization holder) | Shire Pharmaceuticals Ireland Limited (Takeda's subsidiary) |
Drug target | BDKRB2 |
Indication | Icatibant injection is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults, adolescents and children 2 years of age and older. |
Mechanism of action | Icatibant is a competitive antagonist selective for the bradykinin B2 receptor. Icatibant inhibits the influence of bradykinin related to HAE symptoms such as localized swelling, inflammation and pain and thereby treats the acute, episodic attack of HAE. |
2. Junshi Bioscience's Toripalimab Gets Approved with New Indication
Generic name | Toripalimab Injection |
Brand name | Tuoyi |
Classification | Therapeutic biological product |
Time from application submission to approval | 341 days |
Approval date | Apr. 7, 2021 (first marketing approval from NMPA on Dec. 17, 2018) |
Priority review & approval | No |
MAH | Shanghai Junshi Biosciences Co., Ltd. |
Drug target | PD-1 |
Newly approved indication | For the treatment of patients with locally advanced or metastatic urothelial carcinoma who failed platinum-containing chemotherapy or the disease progresses within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. |
Chronology | (1) Toripalimab was approved by NMPA for treating unresectable local progression or metastatic melanoma on Dec. 17, 2018. (2) The drug entered the National Reimbursement Drug List in 2020. (3) Toripalimab's second indication was approved by China NMPA on Feb. 19, 2021. The drug was granted a conditional approval for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy. |
3. Henlius Biotech's Adalimumab Injection Gets Greenlight for New Indication
Generic name | Adalimumab Injection |
Brand name | Handayuan |
Classification | Therapeutic biological product |
Time from application submission to approval | 79 days |
Approval date | Apr. 12, 2021 |
Priority review & approval | No |
MAH | Shanghai Henlius Biotech, Inc. |
Drug target | TNF, FCGR3B, C1S, C1QA, FCGR3A, FCGR2A, C1R, C1QB, C1QC, FCGR1A, FCGR2B, FCGR2C |
Newly approved indication | Noninfectious uveitis at the front, back or full part of uvea. |
Chronology | Adalimumab 汉达远Ⓡ (HLX03), a mAb biosimilar targeting TNF-α (tumor necrosis factor-α), was approved by NMPA for treating rheumatoid arthritis (RA), ankylosing spondylitis (AS) and plaque psoriasis (Ps) on Dec. 7, 2020. |
Counterparts in China | The original drug Adalimumab Solution for Injection owned by AbbVie and the other two generic biological products – Anjianning by Haizheng Biopharmaceutical and Geleli by Bio-Thera Solutions. |
4. AstraZeneca's TAGRISSO Wins Approval for New Indication
Generic name | Osimertinib Mesylate Tablets |
Brand name | TAGRISSO |
Classification | Chemical drug |
Time from application submission to approval | 194 days |
Approval date | Apr. 9, 2021 |
Priority review & approval | Yes (the drug meets the other conditions for priority review & approval) |
MAH | AstraZeneca AB |
Drug target | EGFR (epidermal growth factor receptor) |
Newly approved indication | Adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after tumor resection with curative intent, with or without adjuvant chemotherapy as recommended by the patient's physician. |
5. Takeda's Brentuximab Vedotin Injection Adds Two Newly Approved Indications
Generic name | Brentuximab Vedotin for Injection |
Brand name | ADCETRIS |
Classification | Therapeutic biological product |
Time from application submission to approval | 298 days |
Approval date | Apr. 16, 2021 |
Priority review & approval | No |
MAH | Takeda Pharma A/S |
Drug target | CD30 Tubulin |
Newly approved indications | (1) Relapsed primary cutaneous anaplastic large cell lymphoma (pcALCL); (2) CD30-expressing mycosis fungoides (MF) with adult patients. |
Components | ADCETRIS (brentuximab vedotin) is a CD30-directed antibody-drug conjugate (ADC). It consists of CD30-targeted monoclonal antibody and microtubule disrupting agent MMAE, two of which conjugate through a protease-sensitive linker. |
Chronology | Brentuximab Vedotin was first approved by US FDA for marketing in 2011, becoming the world's second ADC to get marketing approval and first ADC that targets CD30. In China, the drug was first approved in May 2020 for treating adults with (1) CD30-positive relapsed systemic anaplastic large cell lymphoma (sALCL) or (2) relapsed/refractory classical Hodgkin lymphoma (cHL). |
6. Biogen's Patent Drug Tecfidera Obtains Marketing Approval in China
Generic name | Dimethyl Fumarate Enteric Capsules |
Brand name | Tecfidera |
Classification | Chemical drug |
Time from application submission to approval | 423 days |
Approval date | Apr. 17, 2021 |
Priority review & approval | Yes (for it's a rare disease drug) |
MAH | Biogen Netherlands B.V. |
Drug target | / |
Indication | Relapsing forms of multiple sclerosis (MS). |
Mechanism of action | How dimethyl fumarate (DMF) exerts its therapeutic effect on MS is unknown. Dimethyl fumarate (DMF) and the metabolite, monomethyl fumarate (MMF), have been shown to activate the Nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway in vitro and in vivo in animals and humans. The Nrf2 pathway is involved in the cellular response to oxidative stress. MMF has been identified as a nicotinic acid receptor agonist in vitro.
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7. Sanofi's ALPROLIX Gets Granted for Marketing in China
Generic name | Eftrenonacog alfa for Injection |
Brand name | ALPROLIX |
Classification | Therapeutic biological product |
Time from application submission to approval | 495 days |
Approval date | Apr. 23, 2021 |
Priority review & approval | No |
MAH | Bioverativ Therapeutics Inc. (whose parent company is Sanofi) |
Drug target | / |
Indication | To help control and prevent bleeding in adults and children with hemophilia (also called congenital Factor IX deficiency); routine prophylaxis to prevent or reduce the frequency of bleeding episodes, including those happen in the perioperative period. |
Mechanism of action | ALPROLIX is a recombinant, fusion protein that temporarily replaces the missing coagulation Factor IX needed for effective hemostasis. ALPROLIX contains the Fc region of human IgG1, which binds to the neonatal Fc receptor (FcRn). FcRn is part of a naturally occurring pathway that delays lysosomal degradation of immunoglobulins by cycling them back into circulation, and prolonging their plasma half-life. |
8. Novo Nordisk's Semaglutide Injection Gets Approval to Enter the Chinese Market
Generic name | Semaglutide Injection |
Brand name | Ozempic |
Classification | Therapeutic biological product |
Time from application submission to approval | 389 days |
Approval date | Apr. 29, 2021 |
Priority review & approval | No |
MAH | Novo Nordisk Pharma AG |
Drug target | GLP-1 receptor |
Indication | As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. |
Mechanism of action | Semaglutide reduces blood glucose through a mechanism where it stimulates insulin secretion and lowers glucagon secretion, both in a glucose-dependent manner. Thus, when blood glucose is high, insulin secretion is stimulated, and glucagon secretion is inhibited. The mechanism of blood glucose lowering also involves a minor delay in gastric emptying in the early postprandial phase. |
9. Jiangsu Hengrui's Camrelizumab Injection Gains Approval for New Indication
Generic name | Camrelizumab for Injection | |
Brand name | AiRuiKa | |
Classification | Therapeutic biological product | |
Time from application submission to approval | 238 days | |
Approval date | Apr. 29, 2021 | |
Priority review & approval | No | |
MAH | Jiangsu Hengrui Medicine Company Ltd. | |
Drug target | PD-1 | |
Newly approved indication | Late-stage nasopharyngeal carcinoma after at least two lines of prior systemic chemotherapy and the patients (1) have disease progression or (2) are resistant to further chemotherapy. | |
Indications previously approved in China | Approval Date | Indication |
Jun. 3, 2019 | Recurrent or refractory classical Hodgkin lymphoma | |
Mar. 4, 2020 | Late-stage hepatocellular carcinoma (HCC) after sorafenib and/or systemic platinum-containing chemotherapy | |
Jun. 19, 2020 | The combination of camrelizumab, pemetrexed and carboplatin can treat patients with EGFR/ALK late-stage wild-type or metastatic non-squamous and non-small cell lung cancer (NSCLC) | |
Jun. 19, 2020 | Locally advanced or metastatic esophageal squamous-cell carcinoma which gets progressive after prior one line of standard chemotherapy or the patients are resistant to further chemotherapy | |
10. Roche's Patent Drug Xofluza Gets Import Permission to the Chinese Market
Generic name | Baloxavir Marboxil Tablets |
Brand name | Xofluza |
Classification | Chemical drug |
Time from application submission to approval | 324 days |
Approval date | Apr. 29, 2021 |
Priority review & approval | Yes (the drug meets the other conditions for priority review & approval) |
MAH | Genentech, Inc. (member of Roche) |
Drug target | PA (polymerase acidic) |
Indication | Treatment of acute uncomplicated influenza in patients 12 years of age and older who have been symptomatic for no more than 48 hours. |
Mechanism of action | Baloxavir marboxil is a prodrug that is converted by hydrolysis to baloxavir, the active form that exerts anti-influenza virus activity. Baloxavir inhibits the endonuclease activity of the PA protein, an influenza virus-specific enzyme in the viral RNA polymerase complex required for viral gene transcription, resulting in inhibition of influenza virus replication. |
11. Janssen's Daratumumab Injection Approved for New Indication
Generic name | Daratumumab Injection |
Brand name | DARZALEX |
Classification | Therapeutic biological product |
Time from application submission to approval | 300 days |
Approval date | Apr. 27, 2021 |
Priority review & approval | Yes (the drug meets the other conditions for priority review & approval) |
MAH | Janssen-Cilag International NV |
Drug target | CD38 |
Newly approved indication | In combination with lenalidomide and dexamethasone in adult patients with multiple myeloma who have received at least one prior therapy. |
Chronology | Daratumumab is the world's first approved immunoglobulin G1 kappa (IgG1κ) human monoclonal antibody that binds to CD38 antigen. It was first approved by US FDA in Nov. 2015 and later by China NMPA in Jul. 2019 for the treatment of adult patients with relapsed or refractory multiple myeloma which progresses at the last treatment in therapies including a proteasome inhibitor (PI) and an immunomodulatory agent. |
12. Roche's Atezolizumab Injection Approved for New Indication
Generic name | Atezolizumab Injection | |
Brand name | Tecentriq | |
Classification | Therapeutic biological product | |
Time from application submission to approval | 218 days | |
Approval date | Apr. 27, 2021 | |
Priority review & approval | Yes (conditional approval) | |
MAH | Roche Registration GmbH | |
Drug target | PD-L1 | |
Newly approved indication | The first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area [IC ≥ 10%]) with no EGFR or ALK genomic tumor aberrations. | |
Indications previously approved in China | Approval date | Indication |
Feb. 2020 | Used in the first line treatment of combination chemotherapy for the extensive-stage small cell lung cancer (SCLC) | |
Oct. 2020 | Used in combination with bevacizumab in the first-line treatment of adult patients with inoperable hepatocellular carcinoma | |
Mia Li, ChemLinked BaiPharm's drug registration specialist, also contributed to the article. For more information on NMPA drug approvals, please stay tuned to ChemLinked BaiPharm news.
