In the first quarter of 2022, more than 40 new drugs (including new indications) were approved in China| inventory

▎ WuXi AppTec content team reports

The first quarter of 2022 has just concluded. According to incomplete statistics, china's State Food and Drug Administration (NMPA) approved at least 41 new drugs (including new indications, excluding traditional Chinese medicines and vaccines) in the first quarter. Among these approved new drugs, most of them are indications for cancer and immune diseases, and several other antiviral products such as oral new coronavirus treatment drugs, non-nucleoside cytomegalovirus (CMV) inhibitors, and anti-rabies virus monoclonal antibodies are also worthy of attention. From the perspective of targets, there are innovative targeted therapies such as PI3K dual inhibitors, IDH1 inhibitors, VEGFR-2 monoclonal antibodies, and anti-CD19 antibodies. This article will take you to see what are the highlights of the new drugs approved in the first quarter.

Highlight 1: These "first" new drugs were approved in China

Among the new drugs approved for listing in China in the first quarter, many products set a record of "China's first". In the field of innovative drugs, the "first" may have unusual significance for patients, R&D personnel and even the industry as a whole. It may represent the hope of improving symptoms and prolonging the lives of some group of patients without treatment options, or it may mean that a new target, a new technology, and a new treatment model can be validated, opening the door to the development of more innovative therapies in the future.

Screenshot source: 123RF

In terms of innovative targets, PI3K is regarded by researchers as one of the key targets for the development of cancer therapeutic drugs, and a number of PI3K inhibitors have entered the late clinical or marketing declaration stage in China. In March this year, CSPC pharmaceutical group's innovative drug duvelisib capsules introduced from Verastem Oncology were approved for marketing in China for the treatment of adult patients with relapsed or refractory follicular lymphoma who had undergone at least two systematic treatments in the past. According to the press release of CSPC Pharmaceutical Group, Duvelixe capsules are the world's first approved dual oral inhibitors of phosphatidylinositol-3-kinase PI3K-δ and PI3K-γ, and the first approved selective inhibitor of PI3K in China.

Another example is IDH, based on the target to develop tumor targeted therapy is also one of the current cutting-edge research directions, such products by acting on the IDH mutation site, reduce the production of metabolites 2-HG, induce histone demethylation, and then achieve the effect of inhibiting tumor development. In February this year, the IDH1 inhibitor ivosidenib introduced by CStone pharmaceuticals was approved for marketing in China for the treatment of recurrent or refractory acute myeloid leukemia in adults with IDH1 susceptible mutations. According to cstone press releases, Avonib is the first and only IDH1 inhibitor approved in China.

In terms of approved indications, many of the new drugs approved in the first quarter also brought new treatment options to specific patient groups. For example, publicly available information shows that Bristol-Myers Squibb's (BMS) red blood cell maturation agent luspatercept is the first innovative drug approved for the treatment of β thalassemia in China in more than a decade; Eli Lilly and Company's VEGFR-2 monoclonal antibody innovative drug ramucirumab is the first targeted drug approved for the second-line treatment of advanced gastric cancer in China GlaxoSmithKline (GSK) BLyS-targeted belimumab is the first biologic in China to cover indications for systemic lupus erythematosus and lupus nephritis...

Highlight 2: Most of the treatment products for tumors and immune diseases are

Oncology and immune diseases are two major research areas that are currently highly valued in the biomedical industry, and good progress has been made in the development of innovative therapies. Among the new drugs approved in China in the first quarter, from the perspective of approved indications, most of them are mainly treatment products for tumors and immune diseases, and there are also a number of antiviral products that are also worth mentioning.

In the field of anti-tumor, patients with lung cancer, lymphoma, stomach cancer, and microsatellite highly unstable (MSI-H) or mismatch repair defect (dMMR) solid tumors are welcoming new treatment options. In addition to the many "first" new drugs mentioned above, the new anti-tumor drugs approved in China in the first quarter include: Takeda's new generation of potent selective tyrosine kinase inhibitor (TKI) buguetinib tablets (brigatinib) approved for the treatment of ALK-positive non-small cell lung cancer (NSCLC), Yuanda Pharma's therapeutic radiopharmaceutical yttrium [90Y] microsphere injection approved for the treatment of liver metastases in colorectal cancer, and Henlin's anti-PD-1 monoclonal Slullimonumab. Approved for MSI-H adult advanced solid tumors, CSPC Mito anthraquinone hydrochloride liposomes, relapsed or refractory peripheral T cell lymphoma, etc.

In addition, there are some new drugs that have been approved in China to harvest new tumor indications in the first quarter, such as: BeiGene anti-PD-1 antibody tiralizumab, Rongchang biological antibody conjugated drug (ADC) vidicetitomab, CStone Pharmaceuticals RET inhibitor pratinib, Beida Pharmaceutical ALK inhibitor ensartinib, Roche (Roche) PD-L1 inhibitor attilizumab, Novartis mTOR inhibitor everolimus, Novartis dual-target combination therapy darafenib combined with trimetinib and so on.

In terms of immune diseases, atopic dermatitis, rheumatoid arthritis, lupus nephritis, immune thrombocytopenia and other disease treatment areas all ushered in the approval of new drugs in the first quarter. For example, AbbVie JAK inhibitors have been approved in China for 2 consecutive indications for the treatment of atopic dermatitis and rheumatoid arthritis; GlaxoSmithKline targeted therapy bailiyuzumab, a new indication for active lupus nephritis in China; Sanofi atopic dermatitis-targeted biologic dupilumab injection (dupilumab) approved in China for children; Kyowa of Japan Kirin) introduced romiplostim for injection of thrombopoietin (TPO) receptor agonists, approved in China for immune thrombocytopenia, etc. In addition, a number of biosimilars from Chinese companies were also approved for listing or harvested new indications in the first quarter, such as: Chia Tai Tianqing adalimumab, Junshi Bio/Maiwei Bio Adalimumab, GenhoBio Infliximab, Fuhong Henlius Rituximab, etc.

In the field of antivirals, the new drugs approved in the first quarter are also quite bright. For example, Pfizer's oral small molecule new coronavirus treatment drug nematvir tablets/ritonavir tablets combination provides a new choice for oral drugs for the treatment of new coronavirus in China. Another example is the recombinant human anti-rabies virus monoclonal antibody injection omativirumab developed by North China Pharmaceutical, which can directly neutralize the rabies virus in the body and play a passive immune role. It is worth mentioning that these 2 products are also new drugs approved by the NMPA official in the first quarter. In addition, there is Merck (MSD) new non-nucleoside cmUV inhibitor lettemvir, approved by NMPA for the prevention of cytomegalovir infection and cytomegaloviremia.

Highlight 3: Rare diseases and children's medication in the field of a number of new drugs

In recent years, the research and development of rare disease drugs, children's drugs and other varieties has also attracted much attention from the industry, and many products have also obtained "special" review and approval qualifications such as priority review and conditional approval, thus accelerating the hands of patients. In the first quarter, a number of rare diseases and children's drugs were also approved in China.

In the field of rare diseases, such as Sobi's IFNγ antibody emapalumab, which was approved in China through priority review, for the treatment of adults and children with refractory, recurrent or progressive disease or primary hemophagocytic lymphocytosis (HLH) who are intolerant to conventional HLH therapy. Primary HLH is a very rare, rapidly progressive, and often fatal hyperinflammatory syndrome in which IFNγ plays a key role in the development of the disease. Emaliyumab neutralizes the effects of IFNγ, thereby helping these seriously ill patients reach the stage of receiving hematopoietic stem cell transplantation.

Another example is Hansen Pharmaceuticals' innovative product inebilizumab, introduced from Viela Bio, which was approved by NMPA for the treatment of "adult patients with optic nerve myelitis spectrum disease (NMOSD) who are positive for aquaporin 4 (AQP4) antibodies". NMOSD is a rare, severe neuroinflammatory autoimmune disease in which most patients produce autoantibodies to aquaporins called AQP4 in the body. By targeting CD19+ B cells, Inelizumab can deplete B cells more extensively and long-lastingly, and continuously reduce NMOSD recurrence.

In the field of pediatric medicine, the lidocaine hydrochloride powder needle-free transdermal injection system (English trade name: Zingo) and inhaled nitric oxide (English trade name: INOmax) from Lee's Big Pharmaceutical Factory have been approved in China through priority review. Among them, Zingo was approved for preoperative local skin anesthesia for venipuncture or peripheral venous intubation in minors aged 3 to 18 years, and INOmax was approved for the treatment of hypoxic respiratory failure in newborns with pulmonary hypertension with clinical or echocardiographic evidence.

There are also new drugs that have previously been approved in China that have been approved for children's indications. For example, Bayer's factor Xa anticoagulant rivaroxaban tablets have been approved as a new indication for VTE treatment and prevention of VTE recurrence in select children and adolescents under 18 years of age with venous thromboembolism (VTE) at least 5 days after initial non-oral anticoagulation. Another example is the new anti-inflammatory drug dupridosumab approved for new indications for the treatment of moderate to severe atopic dermatitis in children aged 6 years and older and adults with poor control of topical medications or who are not recommended to use topical drugs...

In addition to the above drugs, there are other new drugs that were also approved in China in the first quarter, and I will not introduce them all in this article due to space limitations. Congratulations on the approval of these new drugs in China, bringing more treatment options to patients.

Resources:

China National Food and Drug Administration (NMPA). from https://www.nmpa.gov.cn/zwfw/zwfwpjfbzs/index.html

[2] Press releases and public information of each company

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