Weekly Summary of China's Pharmaceutical News (Nov 18–22, 2024): Breakthrough Therapies, New Drug Approvals, and Clinical Milestones

On November 18, Huahui Health announced that its investigational hepatitis D candidate drug Libevitug (HH-003) received Breakthrough Therapy Designation from the U.S. FDA for the treatment of chronic hepatitis D virus infection. This designation is based on the results of two clinical trials.

Libevitug was granted Breakthrough Therapy Designation by China NMPA in April 2023.

Chronic Delta Hepatitis Virus Infection Depends on HBV Replication, and Its Co-infection with HBV Is Considered the Most Severe Form of Viral Hepatitis, Affecting Approximately 15 to 20 Million People Worldwide; Currently, There Are No Approved Drugs in China and the United States.

Libevitug is an innovative neutralizing antibody that can block the virus from binding to its receptor, prevent the virus from entering liver cells, and neutralize the infection.

On November 18, TenNor Therapeutics announced the successful completion of the Phase 3 clinical trial for its first-in-class new drug TNP-2198 in treating Helicobacter pylori infection, achieving the primary endpoint.

This trial is a multicenter, randomized, double-blind, bismuth quadruple therapy controlled trial led by Professor Zhou Liya from Peking University Third Hospital.

The eradication rate of TNP-2198 triple regimen in different analysis populations is higher than that of bismuth quadruple therapy, and it is effective against drug-resistant infections.

The incidence of adverse events in this regimen is low, with good safety and tolerability.

TNP-2198 is the first new antibacterial drug for Helicobacter pylori infection in 30 years, featuring a unique multi-target synergistic mechanism of action, and is supported by China's major national special projects.

TenNor Therapeutics has completed its seven Phase 1-3 clinical trials, dedicated to providing patients with safe and effective new drugs.

On November 19, Brii Biosciences presented the latest data from its ongoing Phase 2 ENSURE study at the 2024 American Association for the Study of Liver Diseases (AASLD) Annual Meeting.

This study evaluates the effects of experimental small interfering ribonucleic acid (siRNA) elebsiran combined with pegylated interferon alpha (PEG-IFNα) in chronic HBV-infected individuals.

Data at the end of 48 weeks of treatment showed that the HBV surface antigen seroclearance rate was higher in the combination therapy group than in the monotherapy group.

Experts gave positive evaluations of the results, and the company's chief medical officer also stated that the results support the company's goal of developing a functional cure for chronic HBV.

As part of developing a unique approach to functional cure for HBV, the company is advancing multiple combination studies.

Elebsiran is a subcutaneously injectable siRNA investigational drug with activity against HBV and hepatitis D virus.

On November 20, the National Medical Products Administration approved the marketing of Alpha Biopharma's Class 1 innovative drug, Zorifertinib Hydrochloride Tablets (Zereni®). Zorifertinib is the world’s first EGFR-TKI specifically targeting brain metastases in lung cancer, and it is indicated for first-line treatment of certain adult patients with non-small cell lung cancer.

Its international multicenter Phase 3 clinical study has demonstrated strong control over intracranial lesions.

Experts indicate that the study fills the gap in head-to-head randomized controlled research for drug treatment of brain metastases in lung cancer, verifying the benefits across the entire population and the potential of combination therapy with third-generation TKIs.

Alpha Biopharma Collaborates with AstraZeneca to Develop Drug, Addressing Clinical Needs for Brain Metastases in Lung Cancer. Lung cancer is a highly prevalent tumor in China, with NSCLC accounting for a significant proportion and EGFR mutations being common. Central nervous system metastasis is a frequent issue in NSCLC, with the blood-brain barrier and efflux proteins affecting drug penetration. Zorifertinib, as a targeted drug, holds promise to provide an effective treatment option for patients with brain metastases from lung cancer.

On November 21, Infinity Therapeutics announced that its investigational new drug Ifebemtinib has once again been designated as a Breakthrough Therapy by the Center for Drug Evaluation of China's National Medical Products Administration (NMPA), for the indication of first-line treatment in combination with a KRASG12C inhibitor for KRASG12C mutation-positive non-small cell lung cancer.

Ifebemtinib is a first-in-class FAK inhibitor that synergistically enhances various anti-tumor therapies.

The company has initiated relevant clinical studies, and the disclosed data shows that the combination therapy regimen provides significant clinical benefits.

InxMed is also advancing clinical trials and collaborations for other indications, with the registration clinical trial for the first indication, platinum-resistant ovarian cancer, proceeding smoothly.

On November 17, Ascentage Pharma announced that the new drug application for its self-developed novel selective Bcl-2 inhibitor APG-2575 was accepted by the National Medical Products Administration (NMPA) and recommended for inclusion in the priority review process, for the treatment of refractory or relapsed chronic lymphocytic leukemia / small lymphocytic lymphoma.

This is the first domestically developed Bcl-2 inhibitor in China to submit an NDA, with the potential to become the second Bcl-2 inhibitor globally to reach the market.

Its submission is based on the results of a pivotal Phase 2 clinical trial, showing broad prospects in various fields of cancer treatment. The company will accelerate its global development to benefit more patients.

Recently, the HEARTRIP study article on Yangxinshi Tablets led by Academician Han Yaling was published in the internationally authoritative TOP journal *Phytomedicine*, which is ranked in both the CAS and JCR Q1 zones.

This study is the first prospective, multicenter research of its kind in China. The results show that Yangxinshi Tablets are as effective as Trimetazidine in improving exercise tolerance in patients after PCI surgery, meeting the non-inferiority criteria. Moreover, it demonstrates superiority in enhancing patients' psychological status with good safety.

This study provides scientific evidence for traditional Chinese medicine in improving exercise tolerance, demonstrating the advantages of Chinese medicine.

At the same time, its basic research is also presented at relevant conference poster sessions, providing new mechanisms for the treatment of coronary heart disease, etc.

Yangxinshi Tablets Have Been on the Market for Many Years, Emphasizing Research. Shanghai Pharmaceutical Guofeng Will Take This Study as an Opportunity to Continue Contributing to the Construction of Healthy China.

The 47th San Antonio Breast Cancer Symposium (SABCS) 2024 will be held from December 10 to 13 in San Antonio, USA.

At this conference, Hengrui Medicine has 26 studies featuring eight innovative drugs selected for presentation: HER1/HER2/HER4-targeted drug Pyrotinib, CDK4/6 inhibitor Dalpiciclib, PD-1 inhibitor Camrelizumab, multi-target receptor tyrosine kinase inhibitor Famitinib, TPO receptor agonist Hetrombopag, PARP inhibitor Fluzoparib, VEGFR2 inhibitor Apatinib, and HER2 antibody-drug conjugate (ADC) SHR-A1811. Among these, there are three oral presentations, three Poster Spotlights, and 20 poster presentations.

Results of the Funaqizumab for Active Psoriatic Arthritis Study Led by Professor Hejian Zou Presented at the 2024 American College of Rheumatology Annual Meeting.

Funaqizumab is an anti-IL-17 monoclonal antibody drug independently developed by Hengrui Medicine.

This was a randomized, double-blind, multicenter Phase 2 clinical study. The results showed that at week 12, fenebrutinib significantly improved symptoms and signs in patients compared to placebo, with good safety and tolerability. It is expected to provide a new treatment option for patients with active psoriatic arthritis, bringing new hope to patients.

Recently, an article about Hengrui Medicine's innovative drug Funaqizumab was published in the journal *Drugs*.

Funaqizumab is the first domestically developed and approved recombinant anti-IL-17A humanized monoclonal antibody in China.

The completed clinical studies on psoriasis and ankylosing spondylitis have shown good efficacy and favorable safety.

Placebo-controlled phase 2 trials for the treatment of psoriatic arthritis are currently underway, with phase 3 trials for pediatric and adolescent psoriasis planned.

This publication highlights the international innovation and influence of Funanizumab, as well as demonstrates the R&D capabilities of China's innovative pharmaceutical companies. Hengrui will continue to develop new drugs to serve patients worldwide.

On November 21, the marketing application for Chia Tai Tianqing's self-developed Anlotinib Hydrochloride Capsules combined with Penpulimab Injection for first-line treatment of advanced hepatocellular carcinoma was accepted by the CDE, marking Anlotinib's official entry into the gastrointestinal tumor field.

This application is based on the positive results of a Phase 3 clinical study, which showed that the combination therapy significantly reduced the risk of disease progression or death and the risk of death.

Anlotinib has been approved or accepted for 10 indications, covering six major types of cancer. CT Tianqing continues to explore anti-angiogenic combination therapies, providing more treatment options for cancer patients.

On November 19, Buchang Pharmaceutical's exclusive product, Renzhi Jiangtang Capsules, was approved by the National Medical Products Administration as the first secondary protected traditional Chinese medicine variety in China.

RenZhi Jiangtang Capsules consist of 18 Chinese herbal ingredients and are used as an adjuvant treatment for type 2 diabetes.

This approval is a full affirmation of its clinical value, efficacy, and quality, enhancing market competitiveness and brand influence.

As a long-standing traditional Chinese medicine enterprise, Buchang Pharmaceutical is advancing in multiple fields and actively expanding into chemical drugs, biopharmaceuticals, and vaccines, with its competitiveness continuously improving.

At the same time, Buchang Pharmaceutical actively fulfills its social responsibilities and gives back to society through various public welfare activities. The company will adhere to technological innovation, accelerate high-quality development, and produce better medicines for the people.

Recently, Akeso Biopharma announced that the new drug application for Penpulimab in combination with Anlotinib as first-line treatment for advanced hepatocellular carcinoma has been accepted by the NMPA.

This is the fifth indication for Penpulimab, and the application is based on a positive Phase III clinical study.

Primary liver cancer is common, with hepatocellular carcinoma accounting for the majority and having an insidious onset; combination therapy opens new patterns for mid- to late-stage treatment.

Penpulimab is a differentiated PD-1 antibody, developed by Akeso Biopharma and subsequently advanced and commercialized by Tianqing Kangfang (a subsidiary of China Resources Pharmaceutical Group).

Akeso Biopharma is a leading company in innovative biologics, with multiple innovative drug candidates and several new drugs either launched or under review for market approval, aspiring to become a globally leading biopharmaceutical enterprise.