Innovent Biologics also disclosed multiple drug collaborations and research and development progress on the eve of the conference. Although it did not disclose a time signal to turn losses into profits, it also stated at the conference that its confidence in achieving a domestic product revenue target of 20 billion yuan by 2027 has become increasingly firm based on the upcoming commercialization of multiple drugs. On the morning of January 17th, Innovent Biologics announced the disclosure of its newly introduced third-generation EGFR-TKI lung cancer targeted drug, Aoyi Xin ® (Lirotinib tablets) have been approved for marketing by the National Medical Products Administration. In the early morning of the same day, Yu Dechao, the founder, chairman, and CEO of Innovent Biologics, revealed at the JPM2025 conference that six new drug varieties will be launched in 2025, including three heavyweight products, Masidomide, Pitacizumab, and Tetuximab; We plan to submit new drug applications ...
According to the China Medical Device Innovation and Priority Approval Database, two innovative medical devices have entered the special review process in recent public announcements released by local drug regulatory authorities across the country. They are respectively the exercise rehabilitation system of Beijing Tianxing Medical Co., Ltd. (hereinafter referred to as Tianxing Medical) and the disposable angle guided puncture needle of Jiangsu Chunzhen Medical Technology Co., Ltd. (hereinafter referred to as Chunzhen Medical). Tianxing Medical, a leading domestic enterprise in sports medicine Tianxing Medical was founded in 2017 and is a leading domestic enterprise in sports medicine, committed to providing comprehensive clinical solutions for sports medicine. Its products are used in sports medicine equipment, implants, and surgical instruments for shoulder joints, knee joints, foot/ankle joints, hip joints, elbow joints, and hand/wrist joints, with a total of more than 300 specifications approved by NMPA. They have been clinically applied in thousands ...
On the same day, the “Double Heroes” of NO.1 insulin disclosed their performance forecast: Ganli Pharmaceutical “turned over”, and Tonghua Dongbao’s net profit sharply decreased On January 20th, Tonghua Dongbao released its performance forecast, expecting to achieve a net profit attributable to shareholders of the listed company of approximately 40.5277 million yuan in 2024, a decrease of approximately 1.127 billion yuan compared to the same period last year, a year-on-year decrease of approximately 96.53%. The main reason for the performance change is that during the reporting period, a new round of centralized insulin procurement began to be implemented in various provinces and cities across the country, and the bidding prices of the company’s insulin products have decreased to varying degrees, resulting in a decline in sales revenue. On the same day, Ganli Pharmaceutical also released its performance forecast, expecting to achieve a net profit attributable to the owners of the ...
According to the AI News, CITIC Securities stated that policy support for innovative drugs is expected to further increase. In addition, the global sales of ADC drugs will reach 10.4 billion US dollars in 2023, and Chinese companies are accelerating their ADC layout and promotion, gradually ushering in a harvest period; The GLP-1 weight loss track has matured, and competition has shifted from single weight loss to multiple benefits. There are potential opportunities for new targets to go global; The IO multi antibody track AK112 has achieved a breakthrough, and TCE technology has moved from hematological tumors to solid tumors and self immunity. The global competitiveness of innovative drugs in China continues to strengthen, and the NewCo model has become a new choice for innovative drugs to go global. National policies encourage the development of innovative drugs, new technologies drive rapid industry growth, and new opportunities arise for going global. ...
Recently, Hangzhou Sino-US Huadong Pharmaceutical Co., Ltd. (hereinafter referred to as “Sino-US Huadong”), a wholly-owned subsidiary of Huadong Medicine Co., Ltd. (hereinafter referred to as “the Company”), has obtained the approval of the National Medical Products Administration (NMPA) for the exclusive marketing product Cenaparib Capsules (trade name: Paisuning®, research and development code: IMP4297) for marketing, which is used for maintenance treatment of adult patients with advanced epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer after achieving complete remission or partial remission of first-line platinum-containing chemotherapy. About Cenaparib On December 19, 2023, Sino-US Huadong and Shanghai Yingpai Pharmaceutical Co., Ltd. (hereinafter referred to as “Yingpai Pharmaceutical”), a wholly-owned subsidiary of Nanjing Yingpai Pharmaceutical Co., Ltd., signed an exclusive marketing service agreement. Sino-US Huadong obtained Yingpai Pharmaceutical’s exclusive marketing rights for Cenaparib in mainland China. Cenaparib is a novel, highly effective PARP1/2 inhibitor independently developed by Impa Pharmaceuticals. It has ...
In the second half of 2024, domestic TCE bispecific antibody transactions are popular all over the world, and autoimmune-related transactions account for 5 of all 7 domestic TCE bispecific antibody transactions, which can be called the “hottest” type of domestic innovative drugs. It is in this wave of global pharmaceutical companies scrambling for autoimmune TCE bispecific antibody rights that some developers have begun to fall behind, and the most advanced overseas biotech company IGM Biosciences. On January 9, IGM Biosciences announced that the company will lay off 73% of its employees and stop developing two autoimmune candidate drugs, Imvotamab (CD3/CD20 bispecific antibody) and IGM-2644 (CD3/CD38 bispecific antibody). IGM made such a decision because its CEO Mary Beth Harler said that the interim data of the Phase Ib study of Imvotamab in the treatment of rheumatoid arthritis and systemic lupus erythematosus showed that the depth and consistency of B cell depletion ...
On January 20, 2025, Kelunbotai’s Tagolimab injection was approved by the State Food and Drug Administration again, with a new indication of first-line treatment of recurrent or metastatic nasopharyngeal carcinoma in combination with gemcitabine and cisplatin (acceptance number CXSS2400049). The approval of this new indication marks a further expansion of the application scope of Tagolimab in the treatment of nasopharyngeal carcinoma. Nasopharyngeal carcinoma is a malignant tumor that occurs in the nasopharynx. Because its location is hidden and its early symptoms are not obvious, it is often diagnosed in the middle and late stages. https://bydrug.pharmcube.com/
January 17, 2025, San Francisco, USA and Suzhou, China – Innovent Biologics (HKEX: 01801), a biopharmaceutical company dedicated to the research, development, production and sale of innovative drugs in major disease areas such as oncology, autoimmunity, metabolism, ophthalmology, etc., was invited to attend the 43rd Annual JPMorgan Healthcare Conference (JPM). Dr. Yu Dechao, founder, chairman and CEO of the group, delivered a keynote speech on site to share the company’s latest business progress and prospects. In its 13 years of establishment, Innovent Biologics has grown rapidly into a leading biopharmaceutical company in China. Under the guidance of the “sustainable development and global innovation” strategy, it has continuously achieved excellent results. At the beginning of the new year, the company has made important progress: two lung cancer targeted drugs, Dabolu® and Aoyixin®, were approved in succession, and the number of commercial products increased to 14; Xinbilu® was included in the medical ...
The FDA’s Breakthrough Devices Program is a voluntary program aimed at accelerating the review of breakthrough technologies or technologies that can more effectively treat or diagnose life-threatening or irreversible debilitating diseases or conditions. According to data from PharmSmart Medical Devices, there are a total of 32 breakthrough device products that have been approved for market by the US FDA in 2024. According to publicly available information from the FDA, the types of 32 products are mainly focused on passive implantable devices, with orthopedic and cardiovascular implants being the main ones. This article introduces 14 types of implantable devices, as follows: 01. Chest and Abdominal Branch Stent (W.L. GORE&ASSOCYTES, INC.) Indications: Patients with thoracoabdominal aortic aneurysm, as well as those with high surgical risk and proximal renal aortic aneurysm. The main researcher of this product, Dr. Michel Makarou, director of vascular surgery at the University of Pittsburgh School of Medicine, stated ...
Domestic original anti-cancer drugs encounter patent challenges. On January 16, Microchip Biotechnology (688321.SH) issued an announcement stating that on December 30, 2024, Nanjing Zhengda Tianqing Pharmaceutical Co., Ltd. (hereinafter referred to as “Zhengda Tianqing”) filed a request for invalidation of the company’s cedabendamine product patent with the State Intellectual Property Office. After formal review, the State Intellectual Property Office issued a “Notice of Acceptance of Invalidation Request” on January 13, 2025. According to the announcement, the patent involved in the case is an invention patent for “an E-configuration benzamide compound and its pharmaceutical preparation and application” (patent number: ZL201410136761.X). This patent is one of the series of patents that ChipScreen Biotech has laid out for its product line of ChipScreen Biotech, which was applied for by ChipScreen Biotech to the State Intellectual Property Office on April 4, 2014, and was authorized on May 17, 2017. The patent is valid until ...
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