WuXi Biologics' Artemisia Pollen Drops Nearing Launch; BeiGene, SinoPharm, Qilu Among Firms Submitting New Drug Applications

Highlights of the Week

1. WoWu Bio's Artemisia annua Powder Drops Are About to Hit the Market!

2. Qilu Pharmaceutical's Class 2 New Drug Approved for Market Launch

3. Salubris’ Teriparatide Injection Marketing Application Accepted

4. Marketing Applications for Multiple Blockbuster Imported Drugs Accepted

During this period (January 15 to January 22), domestically reported drug production applications in China were still dominated by generic drugs. However, the submission of new drugs and imported drugs accelerated. Among them, Wolwo Bio’s therapeutic biological product, Artemisia annua pollen drops, is imminent for market launch; Salubris has submitted a marketing application for its new osteoporosis drug; Beigene’s introduced IL-6 inhibitor has had its marketing application accepted; additionally, several imported drugs have been submitted for domestic market approval. More updates are as follows:

Domestic Review and Approval · New Developments

This week, the Center for Drug Evaluation (CDE) updated the marketing application status for 90 acceptance numbers (covering 60 drug varieties). Among them, Wolwo Bio’s Artemisia annua Powder Drops and Qilu Pharmaceutical’s Olanzapine Orally Disintegrating Films have attracted significant attention. Further updates are as follows:

Wu Biotech's Artemisia annua Powder Drops Are About to Hit the Market!

Data from Yaozhi shows that Wolwo Bio’s therapeutic biological product, Artemisia annua Powder Drops, has entered the administrative approval stage and is imminent for approval. Artemisia annua Powder Drops is an allergen therapy product indicated for desensitization treatment of allergic rhinitis (with or without conjunctivitis and asthma) in adults caused by Artemisia pollen allergy.

WuXi Biologics’ marketing application for Artemisia annua pollen sublingual drops entered the review and approval stage at the National Medical Products Administration (NMPA) on April 25, 2019, and was officially included in the list of priority review and approval varieties on August 10. It is reported that allergen distribution exhibits regional characteristics: patients allergic to Artemisia pollen are more prevalent in northern regions, whereas those allergic to house dust mites are more common in southern regions. Following the market launch of Artemisia annua pollen drops, WuXi Biologics’ product combination of house dust mite and Artemisia annua pollen is expected to achieve a synergistic effect greater than the sum of its parts (1+1>2). In addition, the Phase I clinical trial of “Artemisia annua pollen allergen sublingual drops” in pediatric patients with allergic rhinitis has been completed, and the product is currently in Phase III clinical trials.

Qilu Pharmaceutical’s Class 2 New Drug Approved for Market Launch

Recently, Qilu Pharmaceutical’s olanzapine orally disintegrating film, submitted as a Class 2.2 chemical drug, received marketing approval, making it the second company to gain approval for this dosage form after Jiangsu Hansoh Pharmaceutical and marking its first orally disintegrating film product.

Olanzapine, originally developed by Eli Lilly, was first launched in China in 1998 for the treatment of schizophrenia, moderate-to-severe manic episodes, and bipolar disorder. Orally disintegrating films offer advantages such as small size, light weight, ease of administration, and avoidance of the first-pass effect, making them particularly suitable for pediatric, geriatric, and patients with dysphagia. Qilu Pharmaceutical’s olanzapine tablets and orally disintegrating tablets have both passed the consistency evaluation. Its olanzapine tablets were included in the expanded volume-based procurement program (“4+7”) at a price of RMB 2.48 per tablet, while its olanzapine orally disintegrating tablets were listed in the third batch of centralized procurement at RMB 6.3 per tablet. The recent approval of olanzapine orally disintegrating films marks another significant addition to Qilu’s portfolio in the central nervous system therapeutic area.

Domestic Review and Approval · Newly Accepted

This week, the CDE accepted 54 new marketing application filings covering a total of 39 drug varieties. Among them, Sinocare’s teriparatide injection marketing application was accepted; Beigene submitted a marketing application for an imported new drug; and Takeda Pharmaceutical’s ALK inhibitor and Eli Lilly’s VEGFR-2 monoclonal antibody import applications were accepted. For more updates, see the table below:

Salubris’ Teriparatide Injection Marketing Application Accepted

On January 19, the marketing application for Salubris’ Teriparatide Injection was accepted by the Center for Drug Evaluation (CDE). Teriparatide Injection is a medication for the treatment of osteoporosis. This product is designed for once-daily administration and requires no reconstitution prior to injection, offering greater convenience for patients. Previously, Salubris’ Recombinant Teriparatide for Injection (Xinfutai®) had already been approved for marketing. Upon approval of the current pre-filled liquid formulation, it will create product synergy and enrich the company’s orthopedic product pipeline.

Teriparatide, originally developed by Eli Lilly and Company, was approved for marketing in the United States in 2002 and approved for sale in China in 2011. This drug is currently the only marketed agent that regulates new bone formation, thereby increasing bone mass and improving bone architecture, and is widely recognized as one of the ideal treatments for osteoporosis. If Salubris’s liquid injection formulation receives approval, it will provide patients with additional therapeutic options.

BeiGene’s IL-6 Inhibitor Marketing Application Accepted by CDE

BeiGene’s New Drug Application for the IL-6 Inhibitor Siltuximab for Injection Accepted by CDE; The Drug Was Included in CDE’s Proposed Priority Review List One Week Prior, Indicated for the Treatment of Adult Patients with Human Immunodeficiency Virus (HIV)-Negative and Human Herpesvirus 8 (HHV-8)-Negative Multicentric Castleman Disease

Source: CDE Official Website

Siltuximab is an IL-6 inhibitor originally developed by Johnson & Johnson and later licensed to EUSA Pharma. In January 2020, BeiGene entered into a collaboration with EUSA Pharma, acquiring the rights to develop and commercialize two drugs, including siltuximab, in the Greater China region.

Since its initial approval in the United States in 2014, siltuximab has been approved in more than 40 countries and regions worldwide for the treatment of patients with HHV-8-negative, HIV-negative multicentric Castleman disease. In China, siltuximab was included in the First Batch of Clinically Urgent Overseas New Drugs due to its status as a medication for rare diseases. The acceptance of the marketing application for siltuximab by the Center for Drug Evaluation (CDE) indicates that the drug is expected to be approved and launched in China soon, providing a new treatment option for patients with Castleman disease.

Eli Lilly's New Gastric Cancer Drug Application Accepted for Review

Eli Lilly’s innovative VEGFR-2 monoclonal antibody, ramucirumab, has had its marketing application accepted by the CDE; the indicated indication is likely second-line treatment for advanced gastric cancer.

In China, Eli Lilly has conducted three clinical trials. Among these, the Phase III study for the treatment of advanced gastric or gastroesophageal junction adenocarcinoma has been completed, while the trial for hepatocellular carcinoma is still ongoing. Therefore, the indication submitted for marketing approval in this instance is likely second-line treatment for advanced gastric cancer.

Source: Yaozhi China Clinical Trials Database

Takeda’s ALK Inhibitor Submitted for Marketing Approval in China

According to Yaozhi Data, Takeda Pharmaceutical submitted and had accepted its marketing application for brigatinib, an imported new drug classified under Category 5.1. Brigatinib is an ALK inhibitor that received accelerated approval from the U.S. FDA in April 2017 for the treatment of patients with ALK-positive metastatic non-small cell lung cancer (NSCLC) whose disease progressed after crizotinib therapy. In May 2020, the FDA approved an expanded indication for brigatinib as a monotherapy for the first-line treatment of patients with ALK-positive advanced NSCLC, confirmed by an FDA-approved diagnostic test. In the latest Non-Small Cell Lung Cancer (NSCLC) Clinical Practice Guidelines released by the U.S. National Comprehensive Cancer Network (NCCN) at the end of 2020, brigatinib was recommended as the preferred first-line treatment for ALK-positive advanced NSCLC.

Data Sources: Yaozhi Data, corporate announcements, and other publicly available online data

Source: Publicly available online information from Yaozhi.com, corporate announcements, etc.

Responsible Editor: Liuli

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