▎WuXi AppTec Content Team Report

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Seven New Drugs Submitted for Marketing Approval in China for the First Time

Hengrui Pharma: Relafusp Alfa Injection

Mechanism of Action: Anti-PD-L1/TGF-βRII Bifunctional Fusion Protein

Indications: First-line treatment of gastric and gastroesophageal junction adenocarcinoma

On September 20, Hengrui Pharma's Class 1 new drug Relafusp Alfa Injection (SHR-1701)Listing ApplicationAccepted by NMPA. According to the press release from Hengrui Pharma, the product's submission for marketing approval is for use in combination with fluorouracil and platinum-based drugs for locally advanced unresectable, recurrent, or metastaticFirst-line Treatment for Gastric and Gastroesophageal Junction Adenocarcinoma. Relafusp-α Injection is independently developed by Hengrui PharmaAnti-PD-L1/TGF-βRII bifunctional fusion protein. The phase 3 clinical trial results of this product were also recently presented at the just-concluded 2024 European Society for Medical Oncology (ESMO) Congress. Analysis shows that,In the population with PD-L1 CPS≥5, SHR-1701 group and placebo groupThe median overall survival (mOS) was 16.8 months and 10.4 months, respectively., reaching statistical difference.

Ocumension, EyePoint: Dexamethasone Implant

Mechanism of Action: Sustained-Release Anti-Inflammatory Drug

Indications: Postoperative Inflammation

On September 20, the marketing application for the dexamethasone implant co-submitted by EyePoint Pharmaceuticals and Ocumension has been accepted. Public information shows that this is OT-502 (trade name: DEXYCU), a new drug introduced by Ocumension for treating postoperative inflammation.It is a novel, biodegradable, single-injection sustained-release anti-inflammatory drug that immediately releases the active ingredient dexamethasone to exert an anti-inflammatory effect after injection, with continuous release for 21-22 days.The phase 3 clinical trial for the treatment of post-cataract surgery inflammation previously conducted in China has already reached its primary endpoint.

Aomu Pharma, Xianju Pharma: Aomekesong Sodium Injection

Mechanism of Action: A New Generation of Targeted Muscle Relaxant Antagonists

Indications: Antagonism of moderate and deep neuromuscular blockade

On September 18, the marketing application for Aom0498 Injection (Oumeikexin Sodium), a Class 1 new drug jointly submitted by Aomo Pharmaceuticals and Xianju Pharmaceuticals, was accepted. According to a recent press release from Aomo Pharmaceuticals, Oumeikexin Sodium (Aom0498) is independently developed by the company.New Generation Targeted Muscle Relaxant AntagonistAccording to the official website of the Chinese Clinical Trial Registry and Information Disclosure Platform, this product is used forAntagonism of Moderate and Deep Neuromuscular BlockadeThe two Phase 3 clinical studies have been completed. The research shows,This product can rapidly reverse rocuronium-induced neuromuscular blockade of varying depths within 3 minutes, allowing surgical patients to quickly regain spontaneous breathing.，Greatly reducing the risk of respiratory depression caused by residual muscle relaxation and the incidence of postoperative complications.

Hengrui Pharma: Recombinant Trastuzumab Injection

Mechanism of Action: HER2-Targeted ADC

Indications: Non-Small Cell Lung Cancer

On September 14, Hengrui Pharma's Class 1 new drug, Recombinant Anti-HER2 Antibody-Drug Conjugate (SHR-A1811) Injection,Listing ApplicationAccepted by the NMPA, this product has also been granted priority review by the CDE for the treatment of patients who have previously received at least one systemic therapy.Locally Advanced or MetastaticHER2Mutated Adult Non-Small Cell Lung Cancer Patients。

Rui Kang Trastuzumab is independently developed by Hengrui Pharma.HER2-Targeted Antibody-Drug Conjugates (ADC). The product treatsHER2Patients with Mutant Non-Small Cell Lung CancerThe main findings of Phase 1 have already been published in a subsidiary journal of *Nature*.Signal Transduction and Targeted TherapyRelease.The results showed,Full-Dose GroupThe objective response rate (ORR) confirmed by the investigatorORR）38.1%,Disease Control Rate (DCR) was 90.5%Among them, the 4.8mg/kg dose group (RP2D, N=43) showed a confirmed ORR of 41.9% based on investigator assessment.DCR is 95.3%。

Pierre Fabre: Encorafenib Capsules

Mechanism of Action: Small Molecule BRAF Inhibitor

On September 7, Pierre Fabre declared a new drug of Category 5.1Encorafenib CapsulesMarketing ApplicationHas been accepted, specific indications have not been disclosed. According to public data from Pierre Fabre, encorafenib (brand name Braftovi) is aOral Small Molecule BRAF Kinase Inhibitor. The product has already been approved in the United States and the European Union for the treatment of cancer indications such as melanoma, colorectal cancer, and non-small cell lung cancer. Based on the progress of clinical research in China, the indication for this marketing application is likely to beBRAF V600EMutant Colorectal Cancer。

It is worth mentioning that the global rights to Encorafenib capsules involve multiple companies, including Pfizer's acquisition of Array in June 2019 for $11.4 billion, through which it gained this orally administered new drug developed by the latter. Currently, Pierre Fabre holds exclusive commercial rights to the product in Europe and the Asia-Pacific region.

Novo Nordisk: Pasireotide Injection

Mechanism of Action: Long-Acting Growth Hormone

On September 5, Novo Nordisk reportedPacify Growth Hormone InjectionThe new drug marketing application has been accepted, and the specific indications have not been disclosed. According to public information, this is a drug developed by Novo Nordisk.Long-Acting Growth Hormone, Once a WeekSogroya® (somapacitan). This is a human growth hormone analog that is similar to the growth hormone produced by the human body. The product has been approved in the United States, the European Union, Japan, Australia, and Saudi Arabia.Only requires one subcutaneous injection per week for the replacement treatment of endogenous growth hormone in patients with Adult Growth Hormone Deficiency (AGHD).. The product is being developed in China for the treatment ofChildren with growth hormone deficiency leading to slow growthA Phase 3 study has now been completed.

Buchang Pharma: Epoetin Alfa Injection

Mechanism of Action: Long-acting Human Erythropoietin (EPO)

Indications: Anemia caused by Chronic Kidney Disease (CKD)

On September 3, the marketing application for Bichang Bio's Class 1 new drug, Eparipobart α for injection, was accepted. According to the announcement by Bichang Pharmaceutical, Eparipobart α is a recombinant fusion protein composed of human erythropoietin (EPO) and the Fc fragment of human immunoglobulin G2 (IgG2), representing a long-acting EPO product. The introduction of Fc increases the molecular weight of EPO, reduces the glomerular filtration rate, and extends its half-life. This product is suitable for treating anemia caused by chronic kidney disease (CKD) in adult dialysis patients who are receiving erythropoietin therapy.

Eight New Drugs with New Indications/New Formulations Submitted for Marketing Approval in China

AbbVie: Venetoclax Tablets

Mechanism of Action: BCL-2 Inhibitor

On September 20, AbbVie's new indication application for venetoclax tablets was accepted, but the specific indication has not been disclosed yet. Venetoclax, developed jointly by AbbVie and Roche (Roche), is...A BCL-2 inhibitor, which was previously approved in China for the treatment of adult patients with acute myeloid leukemia (AML).According to the CDE official website, this is the third marketing application for Venetoclax in China. Currently, Venetoclax has been approved in the United States for the treatment of previously treated and untreated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), acute myeloid leukemia (AML), and other indications.

Eli Lilly and Company: Tirzepatide Injection

Mechanism of Action: GIP/GLP-1 Receptor Dual Agonist

On September 15, Eli Lilly's重磅药物GIP/GLP-1 receptor dual agonist tirzepatide injection new indicationListing ApplicationAccepted for review, specific indications not yet disclosed. According to a query on the CDE’s official website, this is the third marketing application submission for tirzepatide in China. Based on the product's registration progress internationally and clinical research progress in China, it is speculated that the indication for this marketing application may be...Improving Snoring Conditions in Obese Patients with Moderate to Severe Obstructive Sleep Apnea (OSA)。For this indication, Eli Lilly has submitted a marketing application to the U.S. FDA. Results from the SURMOUNT-OSA clinical trial showed that, compared with placebo, tirzepatide reduced patients' apnea-hypopnea index (AHI) by up to an average of 62.8%.Approximately 30 fewer events of restricted or obstructed airflow per hour of sleep.。

Mikasa Seiyaku: Flurbiprofen Patch

Mechanism of Action: Non-Steroidal Anti-Inflammatory Drug

Mikasa Pharmaceutical Co., Ltd. submitted an application under Registration Category 5.1 forFlurbiprofen Patch Marketing Application Accepted for Review. According to publicly available information,Flurbiprofen is a topical nonsteroidal anti-inflammatory drug (NSAID) and is the first-choice medication for treating localized mild to moderate chronic pain. According to publicly available data, the flurbiprofen patch has already been approved in China for multiple indications, including osteoarthritis, periarthritis of the shoulder, etc. In China, the flurbiprofen patch is being developed by Mikasa Pharmaceutical Co., Ltd.Alleviate Knee Osteoarthritis PainThe phase 3 clinical study is currently underway.

Roche（Roche）: Risplam Tablets

Mechanism of Action:SMN2Gene mRNA Splicing Modulator

Indications: Spinal Muscular Atrophy (SMA)

On September 12, Roche's applicationRisdiplam TabletsMarketing ApplicationAccepted for review, specific indications not yet disclosed. Public data shows that risdiplam is an innovative neuro-rare disease drug from Roche.ASMN2Gene mRNA Splicing Modulator for the Treatment of Spinal Muscular Atrophy (SMA). The drug'sOral Solution Dosage FormHas been approved for marketing in China, for the treatment of SMA patients aged 16 days and above. The dosage form of this marketing application isTablet。

For this indication, in June this year,Roche Presents Phase III Trial Results at the European Hematology Association (EHA) CongressSTARGLODetailed results.As of February 16, 2024,The median follow-up time was 20.7 months.Glofit-GemOxContinuously demonstrated superior median compared to the active control groupOverall Survival (OS,25.5 vs 12.9 months), median PFS (13.8 vs 3.6 months), and CR rate (58.5 vs 25.3%)。

Novartis（Novartis）: Eprazinone Hydrochloride Capsules

Mechanism of Action: Oral Complement B Factor Inhibitor

Indications: C3 Glomerulopathy

On September 5, Novartis' Iptacopan Hydrochloride Capsules New IndicationMarketing ApplicationAccepted for review. The listing application was subsequently proposed by the CDE for priority review.For the treatment of adult patients with C3 glomerulopathy (C3G)。Ipsenat is aSpecific Complement Factor B Oral Inhibitor, has been approved in China for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH). This is the third time that Iptacopan has been submitted for marketing authorization in China. According to the information disclosed by Novartis in July this year, the interim results of the Phase 3 clinical trial APPEAR-C3G have been announced.In patients with C3 glomerulopathy, ipokaplan reduced proteinuria levels by 35% at 6 months of treatment compared to placebo.。

Hengrui Pharma: Ivarmacitinib Sulfate Tablets

Mechanism of Action: JAK1 Inhibitor

Indications: Severe alopecia areata in adults

On September 5, Hengrui Pharma's Class 1 new drug, the JAK1 inhibitor Imecitinib Sulfate Tablets, had its new indication marketing application accepted by the NMPA. According to Hengrui Pharma's press release, the indication submitted for this product’s marketing approval isSevere Alopecia in AdultsIn addition to the alopecia areata indication, the marketing authorization applications for three other indications of sulfamethoxazole imatinib tablets have previously been accepted by the NMPA. These indications are proposed for the treatment of moderate to severe atopic dermatitis in adults and adolescents aged 12 years and above, ankylosing spondylitis, and moderate to severe active rheumatoid arthritis.

References:

[1] Website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China. Retrieved Sep 22, 2024, from https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c