▎WuXi AppTec Content Team Report

2023 has come to an end.According to the website of China's National Medical Products Administration (NMPA), last year there were28PaymentInnovative Drugs(Excluding vaccines and traditional Chinese medicine)Officially Approved for Marketing(Referring to the press release published on the NMPA official website)`, this data also hits a new high in nearly 3 years. Among them,`13 New Anti-Tumor DrugsIn this article, let's take a look at what these new drugs are? Which cancer patients have they benefited?（Scan the QR code below the text to obtain the complete PDF file of "New Drugs Approved for Marketing in China in 2023".）

IASO Bio/Innovent Bio: Idecabtagene Vicleucel Injection

Mechanism of Action: BCMA-Targeted CAR-T

Indications: Multiple Myeloma

In June 2023, the NMPA announced the conditional approval of IASO Bio and Innovent Bio's jointly developed Equecabtagene Autoleucel Injection for marketing through the priority review and approval process, intended for the treatment ofAdult patients with relapsed or refractory multiple myeloma (r/r MM)Idecabtagene vicleucel injection is an innovative CAR-T product targeting BCMA, and alsoThe first BCMA-targeted CAR-T therapy approved in China.The product has rapid and potent efficacy, with remarkable persistence in the body, allowing patients to achieve higher and deeper remission.

Evaluation of Idecabtagene Vicleucel Injection for the Treatment of r/r MM Patients: A Chinese Multicenter Phase 1/2 StudyFUMANBA-1 study data show,In terms of efficacy, the ORR was 96.1%, with 91.3% of subjects achieving very good partial response or better (≥VGPR), and the rate of stringent complete response/complete response (sCR/CR) was 77.7%. Among the 91 subjects without a history of prior CAR-T treatment,ORR reached 98.9%, sCR/CR rate reached 82.4%, and the 12-month PFS rate was 85.5%.。

Dizal: Sunvozertinib Tablets

Mechanism of Action: EGFR-TKI

Indications: Non-Small Cell Lung Cancer

In August 2023, the NMPA announced the conditional approval of Dizal Pharmaceutical's Sunvozertinib tablets for marketing. The drug is indicated for the treatment of patients who have experienced disease progression after previous platinum-based chemotherapy, or are intolerant to platinum-based chemotherapy, and have been confirmed through testing.ExistEGFR 20Exon Insertion (EGFR exon20ins）Patients with locally advanced or metastatic NSCLC harboring mutationsSuvoltinib is an oral, irreversible, multi-targetedEGFRHighly selective EGFR-TKI for mutant subtypes.

The approval of Sunvozertinib Tablets is based on the Chinese registration clinical trial (WU-KONG6), which targets patients with disease progression or intolerance to platinum-based chemotherapy.EGFR exon20insA Single-Arm, Multicenter Phase 2 Study in Patients with Advanced NSCLC. In the efficacy analysis population of 97 patients treated with Dizal's drug,The ORR confirmed by IRC reached 60.8%., with safety similar to traditional EGFR-TKIs and overall good tolerability. This study has previouslyPublishIn the internationally authoritative journal "The Lancet Respiratory Medicine" (The Lancet Respiratory Medicine）。

CSPC: Narusobanib Injection

Mechanism of Action: RANKL Monoclonal Antibody

Indications: Giant Cell Tumor of Bone

In September 2023, the NMPA announced the conditional approval of CSPC's subsidiary Jinman Biological's Narucizumab Injection for marketing through the priority review and approval process, intended for the treatment ofAdult patients with giant cell tumor of bone who are ineligible for surgical resection or whose surgical resection may cause severe functional impairmentNaruluximab is a RANKL monoclonal antibody.

According to the announcement previously released by CSPC Pharmaceutical Group Limited, the marketing application of Narusobimab in China is mainly based on two pivotal clinical trials. Clinical research data show that this product has demonstrated favorable efficacy in treating unresectable or surgically challenging giant cell tumors of bone.The tumor response rate in patients was as high as 93.3%.At the same time, Narusobamab also demonstrated good safety and controllable safety risks.

In November 2023, the NMPA announced the approval of Hiteck Biological's Eprenetapoptide for injection, to be used in combination with thalidomide and dexamethasone for adult patients with relapsed or refractory multiple myeloma who have previously received at least two systemic treatment regimens. Eprenetapoptide for injection isRecombinant Altered Human Tumor Necrosis Factor-Related Apoptosis-Inducing Ligand, which can bind to and activate death receptor 4 (DR4) / death receptor 5 (DR5) on the surface of tumor cells, triggering the Caspase cascade reaction in cells through the exogenous apoptosis pathway, thereby exerting an anti-tumor effect.

Roche: Gavreto Injection

Mechanism of Action: CD20×CD3 Bispecific Antibody

Indications: Large B-cell Lymphoma

On November 8, 2023, the NMPA announced the conditional approval of Roche's Gavreto (Gefitinib) Injection for marketing through the priority review and approval process, intended for the treatment ofAdult patients with relapsed or refractory diffuse large B-cell lymphoma who have received at least two prior lines of systemic therapy. Public information shows that this is aCD20×CD3 Bispecific Antibody。

According to an earlier press release from Roche, the approval of Gavreto in China was primarily based on the pivotal Phase 2 expansion cohort data from the NP30179 study. The study results showed that, with a median follow-up of 18.2 months, the IRC-assessedComplete Response (CR) Rate Reaches 40%，ORR reached 52%By the end of follow-up, the majority of patients (68%) remained in CR status.The median duration of CR (DoCR) was 26.9 months., regardless of when patients achieved CR, approximately 70% of patients remained in remission after 18 months. In terms of safety, cytokine release syndrome (CRS) was the most common adverse event, with an incidence rate of 64%, and the vast majority of CRS events were ASTCT grade 1 or 2.

Juventas: Nacia Orencel Injection

Mechanism of Action: CD19-targeted CAR-T

Indications: Acute Lymphoblastic Leukemia

In November 2023, the NMPA announced the conditional approval of Juventas' Nalkylcel Injection for marketing through the priority review and approval process, intended for the treatment ofAdult Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia (r/r B-ALL). Public information shows that Naciorlcel is aA CAR-T cell therapy product targeting CD19, and also the first CAR-T cell therapy product in China's leukemia treatment field.

According to an earlier press release from Juventas, the approval of Naciauclecel was based on a single-arm, open-label, multi-center pivotal clinical study for the treatment of adult r/r B-ALL, which was conducted by the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences.Professor Wang JianxiangServe as the principal investigator. The data show that the treatment with this product brings a sustained high remission rate,ORR reached 82.1%, the median duration of response had not been reached at a median follow-up of 9.3 months;Among patients who still have relief at 3 months, it is estimated that 80% of patients will remain in continuous relief at 1 year.; Whether or not they subsequently undergo hematopoietic stem cell transplantation, they can exhibit sustained remission and long-term survival benefits.

Avistone: Beretinib Enteric-Coated Capsules

Mechanism of Action: c-MET Small Molecule Targeted Drugs

Indications: Non-Small Cell Lung Cancer

In November 2023, the NMPA announced the conditional approval of Avistone's wholly-owned subsidiary, PuriAo Bio, for the market release of Beretinib Enteric-Coated Capsules for treatment.HasMETExon14Patients with locally advanced or metastatic NSCLC who have progressedBoeritinib is a single-target small molecule targeted drug for c-MET. The marketing application for its second indication was included in the priority review by the NMPA in October 2023, targeting adult patients with glioblastoma (GBM).

According to an earlier press release from Avistone, the approval of Beretinib for the treatment of NSCLC is based onMulticenter Single-Arm Clinical Trial Phase 2Positive Results of KUNPENG Study Conducted by Guangdong Provincial People's HospitalProfessor Wu YilongLed by. BIRC-assessedORR was 75.0%，mDoR was 15.9 months，mPFS was 14.1 months, mOS 20.7 months. The ORR for treatment-naïve patients was 77.1%, and for previously treated patients, the ORR was 70.6%. In terms of safety, the overall profile was manageable and tolerable.

In addition to these new drugs, many other innovative drugs were approved by the NMPA in 2023. For more information on the approval of innovative drugs in China in 2023, please click to read "Year in Review: New Drugs Approved for Marketing in China in 2023”。We also look forward to the new year, when China's innovative drug industry will see more new and effective drugs approved and reach patients, allowing the power of science to continue benefiting them.

If you want to learn more about newly approved drugs, please scan the QR code below, youWill receive the content compiled by the WuXi AppTec team"Complete PDF File of New Drugs Approved for Marketing in China in 2023"。