Three Drug Candidates Enter Clinical Trials and One Product Approved for Market: Qilu Pharmaceutical, Hengrui Medicine, and Others Make Progress

According to the announcements from various companies and information from the CDE official website, 3 drugs/therapies have been approved for clinical trials, and 1 drug has been approved for marketing! They are Osthole Oral Soluble Film by Qilu Pharmaceutical, BH011 Injection, an innovative Docetaxel variant by Beihai Biopharma, a GAS6/AXL inhibitor combination therapy introduced by 3D Medicines, and the Medium and Long Chain Fat Emulsion/Amino Acids (16)/Glucose (16%) Injection by Hengrui Medicine.

Three drugs/therapies approved for clinical trials

Qilu Pharmaceutical: Oseltamivir Oral Soluble Film Approved for Clinical Use

According to the information on the CDE official website, the clinical application for Qilu Pharmaceutical's Class 2.2 modified new drug, Oseltamivir Phosphate Oral Soluble Film, has been accepted. This is the first company in China to develop Oseltamivir Oral Soluble Film.

Oseltamivir is a specific inhibitor of neuraminidase, which can prevent mature influenza viruses from detaching from host cells, thereby inhibiting the spread of influenza viruses in the human body to treat influenza.

Currently, in China, there are multiple formulations of oseltamivir under development, including orally disintegrating tablets, sustained/controlled-release formulations, capsules, granules, suspensions, and more. However, no oral soluble film formulation has been developed previously. The oral fast-dissolving film is a novel oral dosage form made by processing the drug with suitable film-forming materials into a film preparation. Once placed in the mouth, it adheres to the administration site, is not easily expelled, disperses quickly, and can reduce instances of patient non-compliance with medication. For systemically acting drugs, the active substance can be directly absorbed through the oral mucosa, bypassing the first-pass effect.

Beihai Biotech: Docetaxel Innovative Drug Approved for Phase 2 Clinical Trial, Targeting Bladder Cancer

Zhuhai Beihai Biotechnology Co., Ltd. announced that it has received the "Drug Clinical Trial Approval Notice" issued by the National Medical Products Administration (NMPA) of China, approving the initiation of a Phase 2 clinical study to evaluate BH011 Injection administered via intravesical instillation for the treatment of intermediate- and high-risk non-muscle-invasive bladder cancer, further expanding the potential beneficiary population.

Transurethral resection of bladder tumor and postoperative intravesical instillation therapy (including chemotherapeutic agents and Bacillus Calmette-Guérin) are the current standard treatment options for non-muscle-invasive bladder cancer. However, after the failure of intravesical instillation therapy, patients have no good second-line treatment options and can only undergo radical cystectomy, leading to a significant decline in quality of life. Therefore, there is an unmet clinical need in this area.

According to the press release, BH011 Injection, developed by Beihai Bio, is an innovative docetaxel variant administered via intravesical instillation. It significantly enhances the permeability of docetaxel in bladder tissue, exposing bladder cancer cells to higher drug concentrations and improving docetaxel's antitumor activity against bladder cancer cells. Preclinical studies of BH011 show that docetaxel can penetrate into the bladder lamina propria, enhancing its antitumor activity against non-muscle-invasive bladder cancer, with no bladder irritation and minimal systemic toxicity.

3D Medicines: Imported GAS6/AXL Inhibitor Combination Therapy Approved for Clinical Use

3D Medicines Announces Approval in China for a Multicenter, Open-Label Phase 1b/2 Clinical Trial of 3D229 Injection in Combination with Envafolimab Injection or Lenvatinib for the Treatment of Advanced Solid Tumors. 3D229, a potential "first-in-class" innovative drug introduced by 3D Medicines, is a GAS6/AXL inhibitor that has previously received Fast Track designation from the U.S. FDA for the treatment of platinum-resistant recurrent ovarian cancer.

Studies have shown that the GAS6-AXL signaling pathway is a key pathway in promoting tumor growth and metastasis, tumor immune escape, and drug resistance. AXL and its ligand GAS6 are highly expressed and activated in many malignant tumors, such as acute myeloid leukemia, renal cell carcinoma, pancreatic cancer, breast cancer, lung cancer, ovarian cancer, and prostate cancer. Moreover, the combination of GAS6-AXL signaling pathway inhibitors with immune checkpoint inhibitors, radiotherapy, or chemotherapy can achieve effective control of tumors.

According to earlier public data from 3D Medicines, 3D229 (also known as: AVB-500) is Aravive's core anti-cancer product. In November 2020, 3D Medicines obtained exclusive rights for the development and commercialization of this product in the field of oncology in Greater China from Aravive. 3D229 is a high-affinity Fc fusion protein specifically targeting GAS6 and also a novel GAS6-AXL signaling pathway inhibitor. Preclinical models have confirmed that 3D229 can selectively inhibit the GAS6-AXL signaling pathway by binding to GAS6 to neutralize its activity. This drug has previously been approved for multiple clinical trials in China.

This approved Phase 1b/2 clinical study is being conducted in patients with advanced solid tumors, including non-small cell lung cancer, clear cell renal cell carcinoma, and urothelial carcinoma. It aims to evaluate the efficacy, safety, tolerability, PK, and PD characteristics of 3D229 injection in combination with either envoplakinib or lenvatinib. Envoplakinib injection (brand name: Envita) is a subcutaneously injectable PD-L1 inhibitor, while lenvatinib is an orally administered multi-kinase inhibitor. Reportedly, by inhibiting the GAS6-AXL signaling pathway, this combination therapy has the potential to demonstrate efficacy across multiple tumor types and may overcome resistance to PD-1/PD-L1 antibodies.

One Drug Approved for Marketing

Hengrui Medicine: Medium and Long Chain Fat Emulsion/Amino Acids (16)/Glucose (16%) Injection Approved for Marketing

According to official news from Hengrui Medicine, the National Medical Products Administration has approved the company's medium and long chain fat emulsion/amino acids (16)/glucose (16%) injection for marketing under Category 4 of chemical drugs, which is deemed to have passed the quality and efficacy consistency evaluation for generic drugs.

Medium and Long Chain Fat Emulsion/Amino Acids (16)/Glucose (16%) Injection is a parenteral nutrition preparation used to supplement the energy and nutritional components required for human physiological functions. When oral or enteral nutrition cannot be administered, is insufficient, or is contraindicated, this product provides the energy, essential fatty acids, amino acids, electrolytes, and fluids needed for parenteral nutrition therapy in patients with mild to moderately severe catabolism.

Medium and Long Chain Fat Emulsion/Amino Acids (16)/Glucose (16%) Injection is packaged in a three-chamber bag. The medium and long chain fat emulsion injection, compound amino acids (16) injection, and compound glucose (16%) injection are located in separate chambers with a membrane in between, keeping them from contacting each other. Upon use, slight pressure can break the membrane, mixing them into an "all-in-one" nutritional solution.

Editor: Qijin

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