PharmaFocus Today – Page 60 – media

Lunan Pharmaceutical’s blockbuster first generic drug approved, ushering in changes in the allergy market

Recently, the official website of the State Food and Drug Administration announced that the orally disintegrating tablets of Bilastine, which were submitted by Shandong Xinshidai Pharmaceutical, a subsidiary of Lunan Pharmaceutical Group, under the Class 3 chemical drug registration classification, have been approved for marketing and are deemed to have passed the generic drug quality and efficacy consistency evaluation. They are used for the symptomatic treatment of urticaria in adults and adolescents (12 years and above). The original product, Bilastine, was developed by FAES Pharmaceuticals of Spain and first marketed in the EU in August 2010. In June 2023, Menarini’s Bilastine tablets were approved for marketing in China. In 2024, Jiangsu Huayang Pharmaceutical secured the first domestic generic version of Bilastine tablets. This time, Lunan Pharmaceutical’s Bilastine orally disintegrating tablets were approved for marketing, marking the first domestic generic version of this dosage form and the first to pass review. ...
- Source: drugdu
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- September 30, 2025
A subsidiary received approval for clinical trials of HRS-2129 tablets. Currently, no drug with the same target has been approved for marketing in China.

According to the AI news of the China Business Network, on September 29, Hengrui Medicine (600276.SH) announced that its subsidiaries Shandong Shengdi Pharmaceutical Co., Ltd. and Shanghai Hengrui Medicine Co., Ltd. received the “Drug Clinical Trial Approval Notice” issued by the National Medical Products Administration for HRS-2129 tablets, agreeing to conduct clinical trials for the indications of adult diabetic peripheral neuropathy pain and adult osteoarthritis pain. HRS-2129 tablets are intended for the treatment of acute and chronic pain. Currently, no drugs with the same target have been approved for marketing in China. As of now, the cumulative R&D investment in this project is approximately 112 million yuan. According to relevant laws and regulations, after obtaining the drug clinical trial approval notice, the drug must still conduct clinical trials and be reviewed and approved by the National Medical Products Administration before it can be produced and marketed. https://finance.eastmoney.com/a/202509293526362066.html
- Source: drugdu
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- September 30, 2025
Eli Lilly’s new drug Inluriyo has been approved by the US FDA for the treatment of advanced or metastatic breast cancer

Recently, Eli Lillyannounced that the U.S. Food and Drug Administration (FDA) has approved its oral estrogen receptor antagonist Inluriyo (imlunestrant, 200 mg tablets) for the treatment of adult patients with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-), ESR1-mutated advanced or metastatic breast cancer (MBC) whose disease has progressed after at least one line of endocrine therapy (ET). https://finance.eastmoney.com/a/202509283525492454.html
- Source: drugdu
- 168
- September 29, 2025
New specifications of sitagliptin and metformin extended-release tablets approved

　　Xuantai PharmaceuticalOn September 26, the company announced that its wholly-owned subsidiary, Jiangsu Xuantai Pharmaceutical Co., Ltd., received the “Notice of Approval of Supplementary Drug Application” from the National Medical Products Administration (NMPA). The NMPA approved the company’s supplemental application for sitagliptin and metformin extended-release tablets to include 50 mg of sitagliptin phosphate (calculated as CHFNO3) and 500 mg of metformin hydrochloride per tablet. Currently marketed, the dosage form contains 50 mg of sitagliptin phosphate (calculated as CHFNO3) and 1000 mg of metformin hydrochloride per tablet. This newly approved dosage form will help better meet patient needs, enhance product competitiveness and market share, and positively impact the company’s future performance. https://finance.eastmoney.com/a/202509263524765181.html
- Source: drugdu
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- September 29, 2025
Based on the logic of prosperity and industry trends, public fundraising explores advantages, styles, and opportunities for “diffusion”

Since the Federal Reserve cut interest rates in September, the technology growth style of the A-share market has continued to strengthen. As of September 26th, several semiconductor equipment related themed ETFs have performed well. Industry institutions analyze that new developments in the artificial intelligence (AI) industry are constantly emerging, and the structural market driven by growth styles is still ongoing. However, with the “pre holiday effect” of the National Day holiday, if there is no significant positive catalyst, the market may be mainly volatile in the near future. At the same time as the valuation of the technology sector enters a high level, the internal rotation of the sector is also accelerating. Industry institutions suggest that the previous extreme structural differentiation and overly concentrated consensus in the market need to be digested and consolidated. In the current market driven by incremental funds and the prosperity of some industries, rotation is ...
- Source: drugdu
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- September 29, 2025
Guangzhou Pharmaceutical Baiyunshan’s fund plans to invest 749 million yuan to become the second largest shareholder of Nanjing Pharmaceutical

On the evening of September 28th, Baiyunshan, a listed company under Guangzhou Pharmaceutical Group, and Nanjing Pharmaceutical Co., Ltd. (hereinafter referred to as “Nanjing Pharmaceutical”) announced that Baiyunshan’s Guangzhou Pharmaceutical Phase II Fund Equity Investment Partnership Enterprise (Limited Partnership) (hereinafter referred to as “Guangzhou Pharmaceutical Phase II Fund”) plans to invest 749 million yuan to acquire 145 million non restricted shares of Nanjing Pharmaceutical held by Alliance Healthcare Asia Pacific Limited (“AHAPL”), accounting for 11.04% of the total shares of Nanjing Pharmaceutical. After the acquisition is completed, Guangzhou Pharmaceutical Phase II Fund will become the second largest shareholder of Nanjing Pharmaceutical. According to the announcement, on September 26th, Guangzhou Pharmaceutical Phase II Fund signed a share transfer contract with AHAPL. The buyer and seller agreed to use the arithmetic mean of the daily closing prices of the target company for the 60 trading days prior to the signing date ...
- Source: drugdu
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- September 29, 2025
Fathers who smoked as teens may accelerate their children’s biological aging

People whose fathers smoked during puberty seem to age faster than expected, according to research presented at the European Respiratory Society (ERS) Congress in Amsterdam, the Netherlands. The researchers found signs of faster biological ageing, compared to chronological age, in people whose fathers began smoking at age 15 or younger. They say smoking during puberty may create damage in boys’ developing sperm cells that can be passed on to their children. The researchers call for stronger efforts to prevent tobacco use in teenagers, not only to benefit the current generation but also future generations. The study was presented by Dr Juan Pablo López-Cervantes from the University of Bergen, Norway. He said: “Our research group has previously shown that smoking during puberty may harm not only the person who smokes, but also their future children. In this new study, we wanted to explore whether parental smoking in puberty may also influence ...
- Source: drugdu
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- September 29, 2025
Remote asthma monitoring keeps children out of the emergency department

Children with asthma who use at-home monitoring are around half as likely to visit the emergency department or be hospitalized, compared to those who only receive care from their medical team, according to research presented at the European Respiratory Society (ERS) Congress in Amsterdam, the Netherlands. Remote monitoring also helped keep children’s symptoms under control. At-home monitoring involved children and their families using an app approximately once a month to answer questions about asthma symptoms or track their lung function. The app also contains asthma action and treatment plans, and information on prescribed medications and instructions on how to use them. At-home monitoring is used to reduce in-person outpatient visits when children have stable asthma symptoms. The research was presented by Dr Martinus Oppelaar from Amalia Children’s Hospital, Radboud University Center, Nijmegen, the Netherlands. He told the Congress: “Our team has previously run a successful clinical trial where we showed ...
- Source: drugdu
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- September 29, 2025
Gene Therapy Slows Huntington’s Disease in Early Trial

FRIDAY, Sept. 26, 2025 (HealthDay News) — A new gene therapy has shown promise in slowing the progression of Huntington’s disease, according to early trial results released Wednesday. In a Phase 1/2 study, patients given a high dose of UniQure’s experimental therapy AMT-130 experienced a 75% slowing of disease progression after three years, the company said. The therapy also reduced levels of a key marker of brain damage — neurofilament light protein in spinal fluid — by an average of 8.2%. “These findings reinforce our conviction that AMT-130 has the potential to fundamentally transform the treatment landscape for Huntington’s disease,” Dr. Walid Abi-Saab, chief medical officer at UniQure, told CNN. The trial, run in partnership with University College London, included 29 patients treated with either a high or low dose of AMT-130 and followed for 36 months. The treatment was delivered surgically by injecting the therapy directly into the brain’s ...
- Source: drugdu
- 128
- September 28, 2025
Regeneron’s Evkeeza Approved in U.S. for Young Children with Homozygous Familial Hypercholesterolemia

Regeneron announced FDA’s approval of its ANGPTL3 antibody Evkeeza for treatment of homozygous familial hypercholesterolemia (HoFH) in children ages 1 to less than 5-years-old. Evkeeza was initially approved in 2021 for use in adults and children aged 12-and-up, and received approval again in 2023 for use in children aged 5 to 11-years-old. Each of Evkeeza’s approvals were reviewed under Priority Review, a process which is reserved for medications representing potential improvements in either efficiency or safety of treating serious diseases. “The approval of Evkeeza for children as young as 1 year of age addresses a critical unmet need for those with homozygous familial hypercholesterolemia, a life-threatening condition that causes extraordinarily high LDL-C levels from birth,” said Katherine Wilemon, founder and CEO of the Family Heart Foundation. “Families and their medical teams will now have an effective treatment option for these very young children who are at risk of serious complications ...
- Source: drugdu
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- September 28, 2025

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