On the evening of July 30th, Anglicorn announced that it had recently received a “Drug Registration Certificate” issued by the National Medical Products Administration for its injection of Metoprolol. According to the announcement information, this drug is mainly used for the treatment of acute skeletal muscle pain or discomfort symptoms, belonging to Class 3 chemical drugs, with a specification of 10ml: 1g, drug approval number H20254988, and an expiration date of July 28, 2030. According to relevant national policies and regulations, obtaining the Drug Registration Certificate this time is considered to have passed the consistency evaluation. The company stated that obtaining the Drug Registration Certificate this time will further enrich its product pipeline. However, due to the particularity of the pharmaceutical industry, the sales of drugs will be affected by factors such as national policies and changes in the market environment, and there is significant uncertainty in the specific sales ...
Researchers at the National Institutes of Health (NIH) have shown for the first time that a type of human papillomavirus (HPV) commonly found on the skin can directly cause a form of skin cancer called cutaneous squamous cell carcinoma (cSCC) when certain immune cells malfunction. cSCC is one of the most common cancers in the United States and worldwide. Previously, scientists believed HPV merely facilitated the accumulation of DNA mutations caused by ultraviolet (UV) radiation, usually the primary driver of cSCC. The findings were published today in The New England Journal of Medicine. This discovery could completely change how we think about the development, and consequently the treatment, of cSCC in people who have a health condition that compromises immune function. It suggests that there may be more people out there with aggressive forms of cSCC who have an underlying immune defect and could benefit from treatments targeting the immune ...
By Ernie Mundell HealthDay ReporterWEDNESDAY, July 30, 2025 (HealthDay News) — You try one of the new blood-based tests for colon cancer, and unfortunately, the results come back “abnormal.” Those are alarming findings, of course. But for too many U.S. patients, no further steps are taken, a new study finds. “Blood-based colorectal cancer screening is promising, but it only works if individuals complete the follow-up colonoscopy,” said study senior author Dr. Folasade May. “More efforts are needed to help patients follow through to actually diagnose and treat the disease,” said May, an associate professor of medicine at the David Geffen School of Medicine at UCLA. Colorectal cancer remains the second-leading cancer killer, with 52,900 related deaths expected during 2025, according to the American Cancer Society. Luckily, there are ways to spot the disease early, when it is most preventable. These include colonoscopy (recommended start time is age 45 for people ...
Drugdu.com expert’s response: The overall prospects for drug registration are positive, driven by factors such as policy support, market demand, improved review efficiency, accelerated internationalization, and innovation-driven development. The industry is rapidly advancing toward high-quality, high-efficiency, and internationalized growth. However, it also faces challenges such as R&D investment, market competition, and regulatory changes. Below is a detailed analysis: I. Dual Drivers of Policy Support and Market Demand Policy Support: The National Medical Products Administration (NMPA) has approved 35% more new drugs through the priority review pathway year-on-year, with anti-tumor drugs accounting for 41%. This policy orientation has significantly accelerated the approval process for innovative drugs, creating a favorable policy environment for drug registration. Market Demand: With an aging population and escalating health needs, the pharmaceutical market continues to expand. By 2025, China’s pharmaceutical market size will exceed RMB 1.6 trillion, representing an 8% year-on-year increase, providing vast market space for ...
On July 30, Zhaoke Ophthalmology (06622) issued an announcement, announcing that its melphalan drug has been granted orphan drug certification by the U.S. Food and Drug Administration (FDA) for the treatment of retinoblastoma in children. This certification lays the regulatory foundation for the company to submit an IND application in the U.S. If melphalan is successfully developed and approved, the company will enjoy seven years of exclusive U.S. market rights after the IND application, protecting both marketing authorization holder status and data exclusivity. Retinoblastoma is a rare eye cancer that primarily affects children under five years old. It affects approximately 200 to 300 cases annually in the United States and approximately 1 in every 15,000 to 18,000 live births worldwide. While the company cannot guarantee the success of the development or commercialization of melphalan, the announcement advises shareholders and potential investors to exercise caution when trading the company’s shares. Source:https://finance.eastmoney.com/a/202507303471632174.html
On July 29, Jiuzhou PharmaceuticalThe announcement stated that it had received the ” Chemical Raw Materials” issued by the State Food and Drug Administration regarding dapagliflozin.The company has received a “Notice of Approval of the Drug Marketing Application” (Notification No. 2025YS00631), confirming that the dapagliflozin API meets the relevant drug registration requirements and formally approved its registration. This will further enrich the company’s product portfolio and enhance its market competitiveness. Dapagliflozin tablets are an important hypoglycemic drug, primarily used to treat adult patients with type 2 diabetes, and are widely used clinically. The announcement indicates that in the first half of 2024, domestic sales of dapagliflozin tablets reached approximately 3.338 billion yuan. As of the date of the announcement, Jiuzhou Pharmaceutical has invested approximately 5.05 million yuan in the research and development of dapagliflozin. Currently, major domestic manufacturers of dapagliflozin APIs include CSPC Pharmaceutical Group Ouyi Pharmaceutical Co., Ltd. and ...
Recently, the National Medical Products Administration officially approved the marketing of the Class 1 innovative drug Maseloxavir Tablets (trade name: Jikeshu) submitted by Nanjing Zhengxiang Pharmaceutical Co., Ltd. It is suitable for previously healthy adult patients with simple influenza A and B (excluding those at high risk of complications). Influenza A and B viruses are seasonally prevalent every year, among which influenza A virus can cause a global pandemic. China’s anti-influenza drug industry is growing rapidly. According to Yaozhi Data [Drug Full Terminal Sales Analysis System], in 2023, my country’s anti-influenza drug sales in the country’s three major terminals (public hospitals + retail pharmacies + e-commerce B2C) will exceed 20 billion yuan. In such a huge market context, Maseloxavir tablets will cause a huge sensation. Maseloxavir tablets are a new-generation, globally proprietary inhibitor targeting the influenza virus RNA polymerase (PA) enzyme. They have rapidly gained recognition for their proven efficacy, ...
Recently, Tongyi Pharmaceutical’s first dual-ligand small drug conjugate CBP-1008 (Rico-V, Ruikefutai) received approval from the NMPA to conduct a Phase III clinical trial in platinum-resistant ovarian cancer (PROC registration). The drug is reportedly a fully chemically synthesized, small bi-ligand drug conjugate (Bi-XDC) with a molecular weight approximately 1/50 of that of traditional ADCs, offering unique advantages in terms of CMC and cost. Rico-V has been approved for Phase III clinical trials and is expected to become the world’s first Bi-XDC drug, offering a new treatment option for ovarian cancer patients. New therapy breaks the deadlock in treating the “king of gynecological cancer” Ovarian cancer ranks first in mortality among gynecological malignancies, earning it the nickname “the king of gynecological cancers.” Because it lacks specific early symptoms and is often diagnosed in its advanced stages, it’s also known as the “silent killer.” According to statistics from the National Cancer Center in ...
By Dennis Thompson HealthDay ReporterMONDAY, July 28, 2025 (HealthDay News) — Cutting-edge immunotherapy drugs are incredibly effective against some cancers but barely put a dent in others – and researchers might now know why. Patients’ own autoantibodies – immune proteins traditionally associated with autoimmune diseases like psoriasis and lupus – appear to dramatically influence their individual response to immunotherapies, researchers report in the journal Nature. “Our analysis shows that certain naturally occurring autoantibodies can tilt the odds dramatically toward shrinking tumors,” senior researcher Dr. Aaron Ring, chair of immunotherapy at Fred Hutchinson Cancer Center in Seattle, said in a news release. “We saw some cases where autoantibodies boosted a patient’s likelihood of responding to checkpoint blockade by as much as five- to ten-fold,” he said. The study focused on immune checkpoint inhibitors, drugs that boost the body’s ability to attack on cancer by removing cancer cells’ ability to evade detection ...
Source: Pharmaceutical Executive The FDA has granted Priority Review and Breakthrough Therapy Designation for Imfinzi (durvalumab) in patients with resectable, early-stage, and locally advanced (Stages II, III, IVA) gastric and gastroesophageal junction (GEJ) cancers. According to the company, these designations were based on results from the Phase III MATTERHORN trial (NCT04592913), which demonstrated that a perioperative Imfinzi-based regimen, administered before and after surgery alongside chemotherapy, significantly reduced the risk of disease progression, recurrence, or death compared to chemotherapy alone.1 How Could the MATTERHORN Trial Results for Imfinzi Change the Treatment Paradigm for Early-Stage Gastric and GEJ Cancers? “This Priority Review reinforces the potential for a perioperative approach with Imfinzi to transform care for patients with early gastric and gastroesophageal junction cancers, who frequently face disease recurrence or progression even after curative-intent surgery and perioperative chemotherapy,” said Susan Galbraith, EVP, oncology hematology R&D, AstraZeneca, in a press release. MATTERHORN Trial Design ...
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