Policy Trends
Fulmin (Hunan) Pharmaceutical Co., Ltd. is under investigation
On December 27th, the National Medical Products Administration issued a notice stating that during a recent flight inspection of Fuermin (Hunan) Pharmaceutical Co., Ltd., it was found that the company violated relevant regulations such as the "Regulations on the Supervision and Administration of Cosmetics" and the "Regulations on the Quality Management of Cosmetics Production", and that there were serious defects in the production quality management system. The National Medical Products Administration has requested that the Hunan Provincial Medical Products Administration investigate and punish the suspected illegal activities of the enterprise in accordance with the law. At present, the Hunan Provincial Drug Administration has launched an investigation into the enterprise and ordered it to suspend production and operation, and rectify the existing problems.
Drug and device approval
The first three common ADC drugs have been approved for market in Japan
On December 27, Daiichi Sankyo announced that the antibody coupling drug (ADC) Datoway (datopotamab deruxtecan) jointly developed by the company and AstraZeneca had been approved in Japan for the treatment of adult patients with hormone receptor (HR) positive, HER2 negative, unresectable or recurrent breast cancer after chemotherapy. This is the first time this therapy has been approved globally.
BeiGene Cancer New Drug Approved by FDA for New Indications
On December 27th, BeiGene announced that the US FDA has approved BeiGene&Co; reg; The combination of trastuzumab and platinum and fluorouracil chemotherapy is used as first-line treatment for adult patients with unresectable or metastatic HER2 negative gastric or gastroesophageal junction (G/GEJ) cancer expressing PD-L1 (≥ 1). This is the second approval granted by the FDA for Trastuzumab in 2024.
AbbVie JAK inhibitor Upatinib new indication declared for market in China
On December 28th, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration announced that AbbVie's application for the new indication of Upadacitinib sustained-release tablets has been accepted. Upatinib sustained-release tablets are a JAK inhibitor that has been approved in China for the treatment of various other indications. This product has just been officially included in the priority review by CDE on December 10th, with the proposed indication for the treatment of adult giant cell arteritis (GCA).
Capital market
Ubix Therapeutics raises KRW 25.7 billion in Pre IPO round funding
Recently, Ubix Therapeutics, a biotechnology company focused on developing targeted protein degradation (TPD) therapies, announced that it has attracted investments worth 25.7 billion Korean won through a Pre IPO round. The funds obtained from this Pre IPO will be used for the clinical development of UBX-303-1 in the United States and South Korea, expansion of new drug pipelines, and acceleration of IPO preparations.
Shengwei Kunteng announces completion of Series A financing of nearly 200 million RMB
Recently, Hunan Shengwei Kunteng Biotechnology Co., Ltd. announced the completion of a Series A financing of nearly 200 million yuan. This round of financing is jointly invested by listed companies Shengxiang Biotechnology, Shengwei Rongquan, and Wojie Capital. The financing funds are mainly used for the research and industrialization base construction of Shengwei Kunteng's new generation molecular POCT products. At the same time, the company announced that Mr. Fan Xu, former Vice General Manager of Shengxiang Biotechnology, will serve as the General Manager of Shengwei Kunteng.
Haobo Pharmaceutical announces completion of $73 million Series B financing
On December 27th, Ausper Biopharma and AusperBio Therapeutics announced the completion of a $73 million Series B funding round. This round of financing is led by Hankang Capital, with joint investment from Sherpa Investment, Dinghui VGC, and a globally renowned industrial investment institution. At the same time, the previous round of investment institutions Qiming Venture Capital, InnoTreasure Fund, and Yuansheng Venture Capital made additional investments. This round of financing will mainly be used to advance the Chinese and international clinical trials of the core small nucleic acid innovative drug AHB-137, as well as preparations for early commercialization. In addition, the funds will also support the expansion of the company's new R&D pipeline and the continuous development and construction of the team.
Industry events
BMS and Abbott Pharmaceuticals reach acquisition agreement
Recently, Bristol Myers Squibb (BMS) announced that it has reached an acquisition agreement with AbbVie Pharmaceuticals (Shanghai) Co., Ltd. (hereinafter referred to as "AbbVie Pharmaceuticals"), and BMS has regained exclusive rights to the development and commercialization of ABZ-706 (RYZ801) in Greater China. At the same time, it also terminated a broad licensing agreement previously signed with Abbott Pharmaceuticals, which granted Abbott Pharmaceuticals the clinical development and commercialization rights for up to four pipeline products of RayzeBio, including ABZ-706, in the Greater China market.
Hengrui Pharmaceutical and IDEYA Biosciences signed an authorization license agreement
On December 29th, Hengrui Pharmaceutical announced that the company has reached an agreement with IDEYA Biosciences to license the Class 1 new drug injection SHR-4849 project, which has independent intellectual property rights, to IDEYA Biosciences for a fee. SHR-4849 is an antibody drug conjugate (ADC) developed independently by Hengrui and with intellectual property rights targeting DLL3. It was approved for clinical trials in the treatment of advanced malignant solid tumors in June 2024.
21 Comment: ADC drugs are becoming an important direction in cancer treatment due to their precise targeting and relatively small side effects. However, the high research and development costs, high technical barriers, intensified market competition, and strict regulatory policies of ADC drugs are the main pain points facing the industry. This cooperation will help Hengrui Pharmaceutical reduce research and development risks, while providing IDEAYA Biosciences with an opportunity to enter the Chinese market and jointly promote the development of ADC drugs.
Public opinion warning
Yiming Pharmaceutical and its subsidiaries have paid additional taxes and late fees totaling 12.171 million yuan
On December 27th, Yiming Pharmaceutical announced that the company and its subsidiaries have recently conducted a self-examination of their tax related businesses. After the self-examination, the company and its subsidiaries need to pay a total of RMB 12.171 million in enterprise income tax of RMB 4.6513 million, value-added tax and surcharges of RMB 6.4847 million, and late fees of RMB 1.035 million. Yiming Pharmaceutical stated that currently, the company and its subsidiaries have fully paid the above-mentioned taxes and late fees, and the competent tax department has not imposed any penalties on the matter.
Shareholders of Shengda Biotechnology plan to reduce their holdings of no more than 3% of the company's shares
On December 27th, Shengda Biotechnology announced that its major shareholder Tiantai Wanjian Investment Development Center, which holds over 5% of the company's shares, plans to reduce its holdings by no more than 5.1357 million shares, accounting for 3% of the company's total share capital. The reduction methods are centralized bidding and bulk trading, and the reduction period is from January 21, 2025 to April 20, 2025. The reduction price will be determined based on market prices. Wanjian Investment and its concerted action parties hold a total of 94.2592 million shares of the company, accounting for 55.06% of the total share capital of the company.
Wuzhou Medical received a regulatory letter from the Shenzhen Stock Exchange
On December 27th, Wuzhou Medical received a regulatory letter from the Shenzhen Stock Exchange. On July 28th, 2020, the Shenzhen Stock Exchange accepted the company's application for initial public offering of shares and listing on the ChiNext board. After investigation, the company and related parties have committed the following violations: the prospectus shows that Huang Fan is one of the actual controllers of the company and serves as the chairman. After investigation, in January 2016, Huang Fan signed an equity proxy agreement with others. In September 2016, Huang Fan transferred the above-mentioned equity to the proxy holder and completed the industrial and commercial registration change. The company did not disclose the above-mentioned equity holding situation in the prospectus. As the first person responsible for information disclosure, the company failed to guarantee the authenticity, accuracy, and completeness of the issuance and listing application documents and information disclosure.
Kexing Pharmaceutical terminated the clinical trial of human interferon α 2b spray project
On December 28, Kexing Pharmaceutical disclosed the information of terminating the clinical trial of human interferon α 2b spray project. Kexing Pharmaceuticals said that, since the human interferon α 2b spray project has only completed Phase I of the clinical trial, which is an early clinical stage, the follow-up of Phase II and Phase III clinical research still needs a large amount of research and development investment. After careful consideration, the clinical trial of the project has been terminated based on competitive product status, market forecast and other factors.
Liu Zhongliang, the actual controller of Weikang Pharmaceutical, has been filed by the China Securities Regulatory Commission
On December 29th, Weikang Pharmaceutical announced that the company and its actual controller Liu Zhongliang received a notice of filing from the China Securities Regulatory Commission. Due to suspected violations of information disclosure laws and regulations, the China Securities Regulatory Commission has decided to file a case against the company and its actual controller Liu Zhongliang.
