NO.1 Yunding Xinyao Cancer Vaccine Approved for Clinical Use in the United States

Yunding Xinyao announced that its universal tumor therapeutic vaccine EVM14 injection has received FDA approval for its IND (New Drug Clinical Trial Application). According to the press release, EVM14 is the company's first independently developed new drug to receive FDA IND approval. EVM14 is a universal tumor therapeutic vaccine targeting multiple tumor associated antigens (TAA), intended for the treatment of various cancers such as non-small cell lung cancer and head and neck cancer.

Comment: Therapeutic vaccines differ from traditional preventive vaccines in that they aim to activate the patient's immune system to combat pre-existing diseases. EVM14 has been approved for clinical use, opening up new ideas for cancer treatment. It can make up for the limitations of traditional treatment, stimulate patients' own immunity to fight against tumors, induce immune memory to reduce the risk of recurrence and metastasis, and strive for "long-term cancer free survival" for patients.

NO.2 Livelihood Health Obtained Minoxidil Liniment Drug Registration Certificate

Hangzhou Minsheng Health Pharmaceutical Co., Ltd. announced that it has received the Drug Registration Certificate for Minoxidil Liniment approved and issued by the National Medical Products Administration. Minoxidil is a peripheral vasodilator that, when used topically for a long time, can stimulate hair growth in male patients with alopecia areata and alopecia areata.

Comment: From the perspective of competitive landscape, the domestic minoxidil market has long been dominated by international pharmaceutical companies such as Merck and Johnson&Johnson, but in recent years, local enterprises have accelerated their layout. The inclusion of people's livelihood and health will further intensify market competition, which may drive down drug prices and promote product innovation.

NO.3 Enhua Pharmaceutical's Class 1 Innovative Drug for Schizophrenia Approved for Clinical Use

The latest announcement on the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration shows that Enhua Pharmaceutical's Class 1 new drug NH140068 tablets have been approved for clinical use and are intended for the treatment of schizophrenia. According to the announcement from Enhua Pharmaceutical, NH140068 is an innovative drug for the treatment of schizophrenia, suitable for oral administration as a multi neurotransmitter receptor agonist. This is the first time that the product has been approved for clinical use in China.

Comment: The pathogenesis of schizophrenia is unclear, there is a lack of precise biomarkers, and the "multiple causes and one effect" make it difficult for a single drug to cover all patients, making drug development difficult. Traditional antipsychotic drugs mainly act on the dopamine and serotonin systems, and have limitations in addressing some symptoms.

NO.4 Shenji Changhua's drug for treating ALS has been approved for clinical use in the United States

Shenji Changhua announced that its independently developed gene therapy drug SNUG01 targeting TRIM72 has been approved for IND (New Drug Clinical Trial Application) in the United States, with indications for amyotrophic lateral sclerosis (ALS, commonly known as "ALS"). According to the press release, this approval marks that the drug will enter the phase 1/2a international multicenter registration clinical trial stage. The system will evaluate its safety, tolerability, and preliminary efficacy in adult ALS patients, achieving the transition from basic research to clinical practice.

Comment: Shenji Changhua SNUG01 has been approved for IND in the United States, which is of great significance for the treatment of ALS. The incidence rate of progressive frostbite is not low, the survival period of patients is short, and the pathogenesis is complex. At present, there is no effective treatment drug in the world. Traditional therapies can only alleviate some symptoms and cannot reverse the condition.

NO.5 GlaxoSmithKline Mabolizumab new indication accepted by EMA

GSK (GlaxoSmithKline) announced that EMA (European Medicines Agency) has accepted its application to expand the use of Nucala (Mabolizumab) as an adjuvant maintenance therapy for patients with eosinophilic chronic obstructive pulmonary disease (COPD). The press release pointed out that if approved, Mabolizumab is expected to become the first approved monthly COPD biologic.

Commentary: COPD is the third leading cause of death worldwide, affecting over 300 million people. The condition worsens repeatedly, seriously damaging patients' health, and new therapies have been scarce for over a decade. If Nucala is approved, it will become the first monthly COPD biologics, with the potential to break the treatment impasse, improve patients' quality of life, and inject new vitality into the global COPD treatment field.