media – Page 16 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

Lunan Pharmaceutical’s Jiali® Oxaliplatin Injection Receives US Marketing Approval

On January 15, Shandong New Era Pharmaceutical Co., Ltd., a subsidiary of Lunan Pharmaceutical Group, received the ANDA 219765 for oxaliplatin injection issued by the U.S. Food and Drug Administration (FDA). This signifies that the product has officially obtained the qualification for commercial sale in the U.S. market. This not only adds an international “passport” to Lunan Pharmaceutical’s anti-tumor product line, but also demonstrates the company’s strong capabilities in quality systems, technology research and development, and international compliance. Oxaliplatin, in combination with 5-fluorouracil and leucovorin (formyltetrahydrofolate), is used in the following applications: (1) Adjuvant therapy for stage III colon cancer after complete resection of the primary tumor. (2) Treatment of advanced colorectal cancer. As an important component of combination chemotherapy regimens, oxaliplatin has less overlap in toxicity with many commonly used antitumor drugs, and has a good safety profile, especially in terms of hematologic and gastrointestinal toxicity. To facilitate the ...
- Source: drugdu
- 81
- January 19, 2026
The second NDA for gumozymab, a new drug application for the treatment of ankylosing spondylitis, has been accepted

Recently, Akeso Biopharma (9926.HK) announced that its novel humanized anti-IL-17A monoclonal antibody, gumozilla (AK111), for the treatment of active ankylosing spondylitis (AS) , has been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). This signifies that the drug is expected to provide a new treatment option for nearly 4 million AS patients in China . Active ankylosing spondylitis (AS) is the second indication for which gumozimab has received NDA acceptance, and its application for the treatment of moderate to severe psoriasis was accepted by the CDEin January 2025 . Gumochimab is Akeso Biopharma ‘s third blockbuster non-oncology product to enter the market , following inunusicumab (PCSK9) and erogenumab (IL-12/IL-23) . With the successive launches of inunusicumab and erogenumab and their inclusion in the National Reimbursement Drug List , and with products such as Gumochimab and Mandozizumab gradually entering the commercialization stage , along ...
- Source: drugdu
- 73
- January 19, 2026
The clinical trial application for its shingles mRNA vaccine has been officially accepted

Securities Daily Online – January 16, 2026 – Zhifei Biologics stated on an interactive investor platform today that the company has established multiple technology platforms, including mRNA and novel adjuvant platforms. These are used to explore various vaccine development pathways to achieve product iterations and innovative breakthroughs. Its wholly-owned subsidiary, Zhifei Longcom, has officially received the Acceptance Notice for its Investigational New Drug (IND) application for a shingles mRNA vaccine from the National Medical Products Administration (NMPA). For further details, please refer to the “Announcement on the Acceptance of the Clinical Trial Application for Shingles mRNA Vaccine” (No. 2025-67). https://finance.eastmoney.com/a/202601163622203690.html
- Source: drugdu
- 70
- January 19, 2026
3.1 billion! Orthopedic giant announces major acquisition.

According to recent foreign media reports, Smith & Nephew, a global orthopedic giant, announced that it has reached an agreement to acquire Integrity Orthopaedics for a maximum of $450 million (approximately RMB 3.1 billion). Image source: Latest Medical Device News on MassDevice Smith & Nephew will reportedly acquire Integrity Orthopaedics with an initial cash payment of $225 million , and will make additional payments over the next five years, up to a maximum of $225 million , depending on the company’s performance. The deal is expected to close by the end of this month. Founded in 2020, Integrity Orthopaedics is a US-based startup focused on sports medicine, specializing in developing innovative shoulder repair and sports medicine products . According to data from PharmNet Medical Devices, the company already has products on the market. Integrity Orthopaedics has developed a rotator cuff repair system called the Tendon Suture System . In its ...
- Source: drugdu
- 71
- January 19, 2026
The Small Nucleic Acid Track is Ushering in a Major Explosion

Small nucleic acid drugs were one of the focal points at this year’s JPM conference. Overseas giants Alnylam and Ionis have both announced breakthroughs in sales of their core products , reflecting the accelerated commercialization of the entire industry. Meanwhile, Chinese companies are rapidly establishing their positions , with innovative biotechnology companies beginning to export their independently developed technologies and pipelines globally, actively participating in global competition. Large domestic pharmaceutical companies are also accelerating their expansion in this sector; China Biopharmaceutical’s acquisition of Hegia for 1.2 billion yuan indicates that the small nucleic acid technology sector is moving from the periphery to the mainstream. 01 High-growth track the market size of small nucleic acid drugs has grown rapidly with breakthroughs in the field of chronic diseases . According to a Frost & Sullivan report, the global small nucleic acid drug market size is expected to grow from US$5.7 billion in ...
- Source: drugdu
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- January 19, 2026
Zhong Sheng Pharmaceutical’s groundbreaking innovative drug joins forces with Qilu Pharmaceutical to target a market worth tens of billions of yuan

Following the successful inclusion of onrapidil tablets in medical insurance, Zhong Sheng Pharmaceutical…(002317) Innovative drug secures another major order. On January 16, ZS Pharmaceutical disclosed an announcement stating that its subsidiary, ZS Ruicheng, has reached a cooperation agreement with Qilu Pharmaceutical to commercialize its innovative drug, RAY1225 injection, a dual-target receptor ultra-long-acting agonist, to Qilu Pharmaceutical. According to the agreement, ZSRay Technology has authorized Qilu Pharmaceutical to manufacture and commercialize RAY1225 injection in China (including mainland China, Hong Kong, Macau, and Taiwan). ZSRay Technology retains the intellectual property rights under the license.All rights, ownership and interests of RAY1225 injection will be retained by ZSRI, while ZSRI will retain all rights, ownership and interests of RAY1225 injection overseas. Subject to the terms of the agreement, ZSRI will receive a total of upfront and milestone payments of up to RMB 1 billion, including an upfront payment of RMB 200 million and development ...
- Source: drugdu
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- January 19, 2026
HEC Pharmaceutical’s Class 1 innovative drug, Ologgliflozin, has been approved for marketing.

Recently, HEC Pharmaceutical’s independently developed Class 1 innovative drug…Ologagliptin capsules have been approved for marketing by the National Medical Products Administration for use as monotherapy or in combination with metformin to improve glycemic control in adult patients with type 2 diabetes. As a new member of the domestic SGLT-2 drug market, its approval is a significant achievement for HEC.This is a milestone in R&D capabilities and a significant breakthrough for the company in the field of innovative drugs . According to the latest report released by the International Diabetes Federation (IDF), there are approximately 150 million adults with diabetes in China, of whom over 90% have type 2 diabetes. Although oral hypoglycemic agents have achieved multi-mechanism coverage, significant clinical challenges remain: on the one hand, patient adherence to medication is generally poor, with an effective blood glucose control rate of only 50.1%; on the other hand, diabetes is often accompanied ...
- Source: drugdu
- 62
- January 19, 2026
【EXPERT Q&A】What are the main materials required for the registration and application of Class II medical devices in China?

Drugdu.com expert’s response: The registration application for Class II medical devices in China requires a range of materials covering multiple aspects to ensure the safety, effectiveness, and quality controllability of the products. Below are the main materials and their detailed descriptions: I. Basic Application Documents Medical Device Registration Application Form: It must be signed by the legal representative or person in charge and stamped with the official seal. All items filled in should be complete and accurate, consistent with the subsequent materials submitted. Usually, two copies are required, with one copy not bound and provided separately. Medical Device Manufacturer Qualification Certificate: Includes a copy of the “Medical Device Manufacturing License” and a copy of the “Business License”. The product applying for registration should fall within the production scope specified in the “Medical Device Manufacturing License”. Both the “Medical Device Manufacturing License” and the “Business License” must be valid. II. Product ...
- Source: drugdu
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- January 19, 2026
【EXPERT Q&A】In vitro diagnostic reagents, if there are changes to matters not stated in the registration certificate and its attachments, is it necessary to apply for a change of registration?

Drugdu.com expert’s response: In the case of in vitro diagnostic reagents, if changes occur to matters not specified in the registration certificate and its attachments, there is no need to apply for a variation of registration. According to the “Measures for the Registration and Filing of In Vitro Diagnostic Reagents” and relevant regulations, when changes occur to matters not specified in the registration certificate and its attachments for in vitro diagnostic reagents, enterprises are not required to apply for a variation of registration with the original registration authority. However, they must control the changed content through their internal quality management systems, with the specific requirements as follows: I. Scope of Changes Not Involving the Registration Certificate Changes to matters not specified in the registration certificate and its attachments typically include, but are not limited to: Adjustments to packaging formats or specifications (e.g., changing from bulk packaging to single-dose packaging); Changes ...
- Source: drugdu
- 71
- January 16, 2026
1.2 Billion Yuan! Sino Biopharm Acquires Another Pharmaceutical Company

Sino Biopharm fully acquires Hegenia, a dark horse in siRNA Space, to enrich its pipeline in Chronic Disease Therapy. 01 Sino Biopharm Scores Another Major Win with the Acquisition Sino Biopharmaceutical Limited (“Sino Biopharm”) has just announced via an official filing that it will acquire Hangzhou Hegenia Biopharmaceuticals Co., Ltd. (“Hegenia”), a small interfering RNA (siRNA) drug developer, for a total consideration of CNY 1.2 billion. Upon completion of the transaction, Hegenia will become an indirect wholly-owned subsidiary of Sino Biopharm. This acquisition marks the first takeover of a domestic siRNA-focused biotech by a large-scale pharmaceutical enterprise in China, and also represents a key strategic move by Sino Biopharm in expanding its innovative drug portfolio. Sino Biopharm stated that the acquisition is aimed at building a next-generation innovative pipeline for cardiovascular therapy, optimizing its strategic layout in the weight management and metabolic disease sector, and further tapping into the ...
- Source: drugdu
- 119
- January 15, 2026

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