PharmaFocus Today – Page 51 – media

Innovative drug amlodipine besylate oral solution lyophilized powder approved for marketing by the US FDA

On July 29, Changchun High-Tech announced that its controlled subsidiary, Beilinian, had received marketing approval from the U.S. Food and Drug Administration (FDA) for its lyophilized powder for oral solution of amlodipine besylate. This lyophilized powder is a modified version of Beilinian’s 505B2 innovative drug for children aged six and older and adults with hypertension and dysphagia. It can lower blood pressure in children and adults aged six and older, and reduce the risk of fatal and non-fatal cardiovascular events. This approval will enrich Beilinian’s product portfolio in the U.S. and enhance the company’s competitiveness in the pharmaceutical market. The FDA approval of this product is a positive attempt by Changchun High-Tech to export its improved innovative drugs overseas, demonstrating that the company has certain international registration and improved drug development capabilities. Source：https://www.yinsfinance.com/article/1393884.shtml
- Source: drugdu
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- August 1, 2025
HB0043, the world’s first dual-antibody drug targeting IL-17A and IL-36R, has been approved for clinical trials

On July 31, Huahai Pharmaceutical announced that its subsidiaries, Huaotai and Huabo Bio, received approval from the National Medical Products Administration (NMPA) for the clinical trial approval of HB0043 for injection. HB0043 is a recombinant humanized IgG1 bispecific antibody targeting human interleukin-17A (IL-17A) and the human interleukin-36 receptor (IL-36R). It exhibits high binding and blocking activity and is being developed for the treatment of various autoimmune diseases. HB0043 is the world’s first bispecific drug targeting both IL-17A and IL-36R. Compared with monoclonal antibodies, HB0043 has a stronger inhibitory effect on cytokine-induced inflammation and fibrosis responses. Through dual blockade of IL-17A and IL-36R, it has demonstrated stronger efficacy than monoclonal antibodies in various animal disease models such as atopic dermatitis (AD), idiopathic pulmonary fibrosis (IPF), diabetic nephropathy (DN), and neutrophilic asthma. Source：https://www.nbd.com.cn/articles/2025-07-31/3997363.html
- Source: drugdu
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- August 1, 2025
Remigipam intermediates series

Migraine is a common chronic neurovascular disease, ranked by the World Health Organization as the third most common and second most disabling neurological disease worldwide. According to statistics, approximately 1.3 billion migraine sufferers worldwide, with approximately 47 million cases in the United States. China has the highest number of migraine sufferers, with over 132 million patients. IQVIA (IQVIA, a leading global healthcare information and strategic consulting company) predicts that the global migraine market is expected to exceed US$13.2 billion in 2026, and sales of calcitonin gene-related peptide (CGRP)-targeted drugs for migraine treatment are expected to exceed US$6.5 billion in 2027. In this field, Remigipam is a milestone. It is the world’s only CGRP receptor antagonist that uses patented orally disintegrating tablet technology. It is also the world’s first drug that can be used for both acute treatment and preventive treatment of migraine attacks. In February 2020, Remdesivir orally disintegrating tablets ...
- Source: drugdu
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- August 1, 2025
Danish pharmaceutical giant undergoes major restructuring

On July 29, Danish pharmaceutical giant Novo Nordisk announced a reduction in its sales and profit growth forecasts for the first half of 2025 (both calculated at CER) and updated its full-year outlook. Novo Nordisk expects sales to grow by 18% and operating profit to increase by 29% in the first half of 2025. For the full year 2025, sales growth is expected to be 8%-14%, and operating profit growth is expected to be 10%-16%. Influenced by this news, Novo Nordisk’s stock price plummeted 21.83%. Its current market value is less than US$240 billion, down more than 60% from more than US$600 billion in July last year. Novo Nordisk announced that the downward revision of its performance expectations was mainly affected by the slowdown in sales growth of its core product semaglutide: 1.The growth of the US weight loss drug Wegovy has slowed, impacted by the continued use of unsafe ...
- Source: drugdu
- 157
- August 1, 2025
Appoint Zhu Yong as a non-executive director and elect him as vice chairman; Over 90% of active equity funds achieve positive returns within the year | Early participation of securities funds

No.1 CITIC Securities: Zhu Yong appointed as non-executive director and elected as vice chairman On the evening of July 30th, CITIC Securities announced that the company held the 16th meeting of the third board of directors and agreed to submit a proposal to the shareholders’ meeting for consideration regarding the election of Zhu Yong as a non-executive director of the company. At the same time, the meeting agreed to elect Zhu Yong as the Vice Chairman of the Third Board of Directors of the company, provided that the proposal to elect Zhu Yong as a non-executive director of the company is approved by the shareholders’ meeting. According to the resume, Zhu Yong, born in June 1969, is currently serving as a director of Central Huijin Investment Co., Ltd. and a director of China Export&Credit Insurance Corporation. Comment: The personnel changes at CITIC Securities have attracted market attention, and if Zhu ...
- Source: drugdu
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- August 1, 2025
Anlikang Meisuobamo Injection has obtained a drug registration certificate

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 ...
- Source: drugdu
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- August 1, 2025
Immunocompromised people are susceptible to skin cancer caused directly by beta-HPV

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 ...
- Source: drugdu
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- August 1, 2025
Blood-Based Colon Cancer Tests Work, But Many Patients Skip Follow-Up

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 ...
- Source: drugdu
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- August 1, 2025
Zhaoke Ophthalmology’s Melphalan Receives FDA Orphan Drug Designation

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
- Source: drugdu
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- July 31, 2025
Jiuzhou Pharmaceutical’s antidiabetic drug dapagliflozin API approved for registration

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 ...
- Source: drugdu
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- July 31, 2025

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