media – Page 23 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

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
API China

Organiser: Sinopharm Reed Exhibitions Time：November 12 – November 14, 2025 address：No. 66 Yuelai Avenue, Yubei District, Chongqing, China Exhibition hall：Chongqing International Expo Center Product range: Pharmaceutical APIs (Active Pharmaceutical Ingredients), pharmaceutical excipients, natural extracts, chemical reagents, intermediates, fine chemical raw materials, key raw materials, food ingredients and additives, veterinary drug raw materials, feed ingredients and additives, health product ingredients and additives, biotechnology, pharmaceutical R&D services, contract custom manufacturing services, registration and pharmaceutical affairs services, training services. About API China ： As the longest-running exhibition in China’s pharmaceutical sector, the China International Pharmaceutical APIs Expo (API China) was first held in 1968. The exhibition showcases not only over 50,000 types of APIs across 24 major categories but also encompasses all excipients, functional ingredients, inner and outer packaging materials, as well as production and testing equipment required for the manufacturing of pharmaceuticals and health products.
- 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
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- 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
【EXPERT Q&A】What materials or documents are needed for a medical device registration certificate?

Drugdu.com expert’s response: The materials required for applying for a medical device registration certificate cover multiple aspects, including enterprise qualifications, product technology, quality control, clinical evaluation, and compliance declarations. The specifics are as follows: Application Form: Fill out the Medical Device Registration Application Form, ensuring that the information is accurate and complete. It should cover basic product information, the registration applicant, and the intended use of the product, among other details. Proof Documents: Copies of the business license and organization code certificate (newly registered enterprises may use the unified social credit code instead and may not need to provide the organization code certificate separately) to prove the legal operation of the enterprise. Identity proofs and copies of educational or professional qualification certificates for the legal representative, enterprise leader, and quality leader to confirm the identities and qualifications of key enterprise personnel. A list of technical personnel along with copies of ...
- Source: drugdu
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- September 29, 2025

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