March 2025: 12 Blockbuster Drugs Approved Globally, Spanning Oncology, Autoimmune, and Rare Diseases

In March, multiple innovative drugs were approved for marketing worldwide (including new indications). These new drugs cover various types of treatments such as monoclonal antibodies, bispecific antibodies, and small molecules, offering new therapeutic options for lung cancer, multiple myeloma, kidney disease, and more. Sina Medicine has selected 12 significant newly approved drugs and information on 2 combination therapies to help everyone stay informed about the latest drug developments over the past month.

Novartis:Radioligand Therapy Pluvicto

Drug Type: Radiopharmaceuticals

Indications: Prostate Cancer

On March 28, 2025, Novartis announced that its radioligand therapy Pluvicto (lutetium Lu 177 vipivotide tetraxetan) received approval from the U.S. Food and Drug Administration (FDA) for the treatment of patients with prostate-specific membrane antigen (PSMA)-positive, metastatic castration-resistant prostate cancer (mCRPC). This approval was based on the results of the Phase 3 PSMAfore clinical trial. In the trial, compared to switching ARPI therapy, Pluvicto significantly reduced the risk of radiographic progression or death by 59% (hazard ratio HR=0.41; 95% confidence interval: 0.29, 0.56; p<0.0001), and the median radiographic progression-free survival (rPFS) was more than doubled (11.6 months vs. 5.6 months).

Roche: Enalise

Mechanism of Action: PI3Kα Inhibitor

Indications: PIK3CA-mutated HR+/HER2- breast cancer

On March 14, Roche announced the approval and market launch of Inavolisib tablets in China, in combination with Palbociclib and Fulvestrant, for adult patients with locally advanced or metastatic breast cancer who are HR-positive, HER2-negative, have PIK3CA mutations, and are resistant to endocrine therapy (including recurrence during or after adjuvant endocrine therapy). Inavolisib tablets are third-generation highly selective PI3Kα inhibitors with a unique dual mechanism of action. They achieve sustained inhibition of tumor signaling pathways through high-specificity selection and efficient degradation of the p110α subunit. When combined with CDK4/6 inhibitors and endocrine therapy drugs, they simultaneously inhibit the PI3K, CDK4/6, and estrogen receptor pathways, deepening responses and blocking resistance pathways through synergistic effects.

Johnson & Johnson: Guselkumab

Drug Type: IL-23 Inhibitor

Indications: Crohn's Disease

On March 20, 2025, Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) had approved its drug guselkumab for the treatment of moderate to severe active Crohn's disease (CD). This is the first and only IL-23 inhibitor offering dual options of subcutaneous (SC) and intravenous (IV) induction therapy. In the pivotal Phase 3 GRAVITI study, patients receiving guselkumab subcutaneous maintenance therapy showed significantly higher rates of clinical remission and endoscopic response at week 48 compared to the placebo group. Additionally, guselkumab demonstrated superior endoscopic endpoint data over ustekinumab (Stelara) in the GALAXI program.

Guselkumab is the first approved fully human, dual-action monoclonal antibody.

AbbVie:Risankizumab

Drug Type: IL-23 Inhibitor

Indications: Crohn's Disease

On March 20, 2025, AbbVie's Risankizumab was approved for marketing by the National Medical Products Administration (NMPA) in China. It is indicated for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response, lost response, or were intolerant to conventional therapy or biologic therapy. Risankizumab is a humanized monoclonal antibody targeting the p19 subunit of interleukin-23 (IL-23). IL-23 plays a key role in the pathogenesis of inflammatory bowel disease (IBD), and by inhibiting IL-23, Risankizumab effectively reduces intestinal inflammation.

Innovent Biologics:Titeomab N01 Injection

Drug Type: IGF-1R Monoclonal Antibody

Indications: Thyroid Eye Disease

In March 2025, Innovent Biologics' Teprotumumab biosimilar was approved by the China National Medical Products Administration (NMPA) for marketing to treat Thyroid Eye Disease (TED). According to Innovent's press release, this is the first new drug in China’s TED treatment field in 70 years and also the first antibody drug targeting Insulin-like Growth Factor 1 Receptor (IGF-1R) in China, as well as the second such drug globally. Teprotumumab is a monoclonal antibody targeting IGF-1R, which alleviates inflammation and ocular symptoms in TED patients by inhibiting the activity of IGF-1R.

Hutchmed: Tazemetostat

Drug Type: EZH2 Methyltransferase Inhibitor

Indications: Follicular Lymphoma

On March 21, Hutchison MediPharma announced that tazemetostat had been granted conditional approval in China for the treatment of patients who have previously received at least two systemic therapies.EZH2Adult patients with mutation-positive relapsed or refractory follicular lymphoma (FL). Tazemetostat is aEZH2 Methyltransferase Inhibitor, which has received accelerated approval from the U.S. FDA for the treatment of certain patients with relapsed/refractory follicular lymphoma and certain patients with advanced epithelioid sarcoma. HUTCHMED has entered into a strategic collaboration with Epizyme, under which it is responsible for the research, development, manufacturing, and commercialization of the product in mainland China, Hong Kong, Macao, and Taiwan.

Novartis:Iptacopan Hydrochloride Capsules (Iptacopan)

Drug Type: Specific Alternative Complement Pathway Factor B Inhibitor

Indications: Glomerulopathy (C3G)

On March 20, 2025, Novartis announced that its oral medication Iptacopan hydrochloride capsules (Iptacopan) received approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult C3 glomerulopathy (C3G) to reduce proteinuria. This is the first and only approved therapy for treating C3G. Fabhalta is an oral, specific alternative complement pathway factor B inhibitor that reduces the deposition of C3 protein in the glomeruli by inhibiting the overactivation of the alternative complement pathway, thereby alleviating inflammation and kidney damage. Based on the results of the Phase 3 APPEAR-C3G trial (NCT04817618), Fabhalta demonstrated significant efficacy in reducing proteinuria, showing effects as early as 14 days after the start of treatment and lasting up to 12 months.

UCB:Rozelimab (Rituximab)

Drug Type: CD20-Targeted Monoclonal Antibody

Indications: Myasthenia Gravis

On March 31, the National Medical Products Administration (NMPA) approved the listing of UCB's Rozelimab Injection for use in combination with conventional therapies to treat adult patients with generalized myasthenia gravis (gMG) who are positive for acetylcholine receptor (AChR) or muscle-specific receptor tyrosine kinase (MuSK) antibodies. This is the world’s first and only innovative drug for treating both subtypes of generalized myasthenia gravis.

Rozelimab (Rituximab) is a chimeric monoclonal antibody targeting CD20-positive B cells. It is commonly used to treat certain types of non-Hodgkin lymphoma, chronic lymphocytic leukemia, and autoimmune diseases such as rheumatoid arthritis. It works by binding to the CD20 antigen on the surface of B cells, marking these cells for recognition and elimination by the immune system.

GSK：Gepotidacin

Drug Type: Triazoloacridine Class II Topoisomerase Inhibitor

Indications: Follicular Lymphoma (FL)

Recently, GSK (GlaxoSmithKline) has achieved a significant breakthrough in the field of antibiotics as the U.S. Food and Drug Administration (FDA) officially approved its first-in-class novel oral antibiotic, Gepotidacin. Gepotidacin is the first new oral antibiotic specifically for the treatment of uncomplicated urinary tract infections (uUTI) to be introduced in nearly 30 years, and it received FDA approval through the priority review pathway. The drug's indications cover uUTIs caused by the following bacteria: Escherichia coli (commonly known as E. coli), Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus, and Enterococcus faecalis, including strains that have developed resistance to existing antibiotics.

Pfizer: Elranatamab

Drug Type: CD38 Monoclonal Antibody

Indications: Relapsed/Refractory Multiple Myeloma (RRMM)

On March 10, 2025, Elranatamab, a bispecific antibody drug developed by Pfizer, received conditional approval from the National Medical Products Administration (NMPA) of China for marketing. The drug is mainly used to treat adult patients with relapsed or refractory multiple myeloma (RRMM) who have previously received at least three lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Elranatamab is a bispecific antibody targeting B-cell maturation antigen (BCMA) and CD3. It activates T cells to attack cancer cells by binding to BCMA on the surface of multiple myeloma cells and CD3 on the surface of T cells. The drug is administered via subcutaneous injection, which is more convenient than intravenous injection and may reduce the occurrence of potential side effects such as cytokine release syndrome (CRS).

Roche: Thrombolytic Agent TNKase (Tenecteplase)

Drug Type: Tissue Plasminogen Activator

Indications: Thrombolytic Agents

Genentech, a member of the Roche Group, announced that the FDA has approved the thrombolytic agent TNKase (Tenecteplase) for the treatment of acute ischemic stroke (AIS) in adults. TNKase is a tissue plasminogen activator that works by dissolving blood clots. TNKase is administered via a single five-second intravenous bolus, initiating a biochemical reaction that breaks down fibrin, a key component of blood clots. Study results have shown that, in patients with acute ischemic stroke, TNKase is comparable to Activase in terms of safety and efficacy.

AstraZeneca:Durvalumab

Drug Type: PD-L1 Inhibitor

Indications: Limited-stage small cell lung cancer (LS-SCLC)

On March 19, AstraZeneca announced that its key immunotherapy drug Durvalumab had been approved by the European Commission as a monotherapy for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease had not progressed after platinum-based chemoradiotherapy (CRT). Clinical trial results showed that, compared with placebo, Durvalumab reduced the risk of death by 27%, with an estimated overall survival (OS) of 55.9 months in the Durvalumab group. It also reduced the risk of disease progression or death by 24%, with a median progression-free survival (PFS) of 16.6 months. The estimated proportion of patients without disease progression at two years was 46% in the Imfinzi group.

Bristol-Myers Squibb:Nivolumab Injection + Ipilimumab Combination Therapy

Drug Type: Nivolumab is an IgG4 monoclonal antibody, and Ipilimumab is an anti-CTLA-4 monoclonal antibody.

Indications: Hepatocellular Carcinoma (HCC)

On March 31, Bristol-Myers Squibb announced that the combination therapy of its two immuno-oncology drugs, Opdivo (nivolumab injection) and Yervoy (ipilimumab injection), received approval from China's National Medical Products Administration (NMPA) for a new indication. The therapy is indicated for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma (HCC), making it the first and currently the only dual immunotherapy approved in China for first-line treatment of hepatocellular carcinoma.

Opdivo (Nivolumab):It is a human immunoglobulin G4 (IgG4) monoclonal antibody that binds to programmed cell death protein 1 (PD-1), blocking the interaction between PD-1 and its ligands PD-L1 and PD-L2, thereby inhibiting the PD-1 pathway-mediated immunosuppressive response and exerting an anti-tumor effect.

Yiwo (Ipilimumab):It is a recombinant human monoclonal antibody that blocks the interaction between cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) and its ligands CD80/CD86 by binding to CTLA-4, thereby enhancing T-cell activation and proliferation to exert an anti-tumor effect.

MSD:Keytruda in combination with trastuzumab, fluoropyrimidine, and platinum-based chemotherapy

Drug Type: PD-1 Inhibitor

Indications: Combined use for gastric cancer or adenocarcinoma of the gastroesophageal junction

On March 20, the FDA announced the full approval of Merck (MSD)'s重磅 PD-1 inhibitor Keytruda (Pembrolizumab) in combination with trastuzumab, fluoropyrimidine, and platinum-based chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2-positive gastric cancer or gastroesophageal junction adenocarcinoma. Studies have shown that in patients with PD-L1 CPS≥1, the median PFS in the Keytruda group was 10.9 months, the median OS for the Keytruda group and the control group were 20.1 months and 15.7 months respectively, ORR were 73% and 58%, and the median DOR were 11.3 months and 9.6 months respectively. The adverse event profile of patients receiving Keytruda was consistent with the known safety profile of Keytruda.

Editor: Zhang Jie

Content Cooperation:A Jie 13051235100