21 Health Daily | Insulin Special Re-procurement Winning Drugs Listed; Executive Changes at Kangyuan Pharma and Other Companies

Jul 16, 2024 21:00 CST Updated 21:00

BeOne

Developer of Molecular Targeted and Immune Anti-Tumor Drugs

AusperBio

Biological Vaccine and Nucleic Acid Drug Developer

Source: 21st Century Economic Report

Editor: Ji Yuanyuan, Xu Qiulian

Welcome to follow the latest events in the pharmaceuticals and health industry with the 21st Century Economic Report's New Health team!

Policy Trends

Insulin Special Continuation Selected Drug Listing

On July 15, the Shanghai Sunshine Pharmaceutical Procurement Network released the "Notice on the Listing of Winning Drugs for the National Drug Centralized Procurement (Insulin Special Continuation)." The Notice stated that, to implement the requirements for the National Drug Centralized Procurement (Insulin Special Continuation) and its utilization, proactive and steady efforts will be made to carry out the listing of selected drugs in the city. The channel for listing the selected drugs has now been opened.

Drug and Device Approval

BeOne Medicines' Class 1 New Drug BG-C9074 Injection Approved for Clinical Trials

On July 15, the official website of the Center for Drug Evaluation (CDE) under the China National Medical Products Administration announced that BeOne Medicines' Class 1 new drug, BG-C9074 Injection, has been approved for clinical trials. It is intended for development to treat advanced solid tumors. According to publicly available information, this is an antibody-drug conjugate (ADC) targeting B7H4, and a global Phase 1 first-in-human clinical trial is currently underway. In July 2023, BeOne Medicines entered into a collaboration exceeding $1.3 billion with Duality Bio, thereby obtaining global development and commercialization rights for this ADC product.

Ipsen Announces NMPA Approval of Six-Month Formulation of Triptorelin Pamoate for Injection

On July 15, Ipsen announced that the six-month formulation of triptorelin pamoate for injection has been officially approved by the National Medical Products Administration (NMPA) in China for the treatment of central precocious puberty (CPP). Compared with short-acting formulations, the long-acting sustained-release formulation allows continuous drug release over several months. Patients and their families only need to visit the hospital every six months for injection treatment and follow-up observation, effectively reducing the number of injections and outpatient visits, and minimizing the adverse impact of long-term treatment on the daily lives of patients and their families.

Shenzhen Kangtai Biological Products Co., Ltd.'s Quadrivalent Influenza Virus Split Vaccine Clinical Trial Application Accepted

On July 15, Shenzhen Kangtai Biological Products Co., Ltd. announced that it had received the acceptance notice issued by the National Medical Products Administration (NMPA), approving the clinical trial application for the quadrivalent influenza virus split vaccine (MDCK cell) jointly developed by the company and Lanzhou Bailin Biotechnology Co., Ltd. Shenzhen Kangtai Biological Products stated that MDCK cell-based influenza vaccines from manufacturers such as Seqirus have already been approved for marketing overseas. According to a search on the website of the National Medical Products Administration, currently in China, no quadrivalent influenza virus split vaccine (MDCK cell) has been approved for marketing.

21 Comments: Currently, China's quadrivalent influenza vaccine market is mainly dominated by a few large companies, such as Hualan Vaccine, Jindike, and Beijing Sinovac. However, in recent years, price wars have emerged in the quadrivalent influenza vaccine market. Against this backdrop, companies are accelerating innovation, attempting breakthroughs in preparation technology, immune mechanisms, and safety, which has led to new growth opportunities. Meanwhile, although price wars may affect companies' sales revenue in the short term, in the long run, they help stimulate market demand and increase vaccination rates.

Capital Market

AusperBio Completes $37 Million Series A Financing

On July 15, AusperBio announced the completion of a $37 million Series A financing round. This round was led by InnoPinnacle Fund with additional investment from Vivo Capital, H&Q China, Qiming Venture Partners, and OrbiMed. The funds will primarily be used to rapidly advance the Phase II clinical trial of AusperBio's potential cornerstone drug for hepatitis B cure, AHB-137, explore combination therapy options, and support a series of development activities including CMC production. Additionally, the financing will also be utilized to expand the proprietary Med-Oligo™ technology platform and its product pipeline.

Industry Highlights

Johnson & Johnson Announces the Appointment of Zhou Mintao as President of Medical Technology, China

On July 15, Johnson & Johnson announced that Zhou Mintao would serve as the president of its MedTech China region and report to Vishnu Karla, chairman of Johnson & Johnson MedTech Asia-Pacific. Meanwhile, Zhou Mintao has also become a member of the Johnson & Johnson MedTech Asia-Pacific leadership team.

Wang Xiaoyang, Director, Deputy General Manager, and Secretary of the Board of Haixiang Pharmaceutical, Resigns

On July 15, Haixiang Pharmaceutical announced that the board of directors had recently received a written resignation report from Wang Xiaoyang, a director, vice general manager, and board secretary of the company. Due to personal reasons, Wang Xiaoyang applied to resign from the positions of director, vice general manager, and board secretary.

Kangyuan Pharmaceutical Vice General Manager Wu Yun Resigns

On the evening of July 15, Kangyuan Pharmaceutical announced that the board of directors had recently received a written resignation report from Wu Yun, the company's vice general manager. Due to personal reasons, Wu Yun applied to resign from his position as the company’s vice general manager. The board of directors agreed to appoint Pan Peng as the company secretary, with a term starting from the date this board resolution is passed until the end of the current board’s term.

PrPharm Continues Collaboration with U.S. Biotech on Ovarian Cancer Drug Project

On July 15, Prima BioPharma announced the continued in-depth collaboration with a U.S.-based new drug company on an ovarian cancer new drug project. Following the earlier assistance provided to the company in completing the production of early clinical trial samples, both parties have moved forward with further cooperation. Prima BioPharma will optimize the formulation process for the new drug and continue to produce later-stage clinical trial samples as well as support future commercial production.

Public Opinion Early Warning

Abnormal Fluctuation in ST Longjin Stock Trading

On July 15, ST Longjin issued an announcement on unusual trading fluctuations, stating that the cumulative deviation of closing price increases for its stock had reached 12% over three consecutive trading days (July 11, 2024, July 12, 2024, and July 15, 2024). According to the regulations of the Shenzhen Stock Exchange Trading Rules, this constitutes an abnormal fluctuation in stock trading. ST Longjin stated that the company, along with its controlling shareholder and actual controller, reviewed the situation regarding the unusual stock trading fluctuations. No corrections or supplements are needed for previously disclosed information, and recently, public media has not reported any undisclosed material information that could or has significantly impacted the company’s stock trading price.

Final Decision on the Second Instance of Xiangyu Medical Construction Engineering Contract Dispute

On July 15, Xiangyu Medical announced that the case regarding the construction engineering contract dispute with Henan Wujian Construction Group Co., Ltd. has entered the second-instance judgment stage. The judgment result was to dismiss the appeal and uphold the original verdict. According to the ruling, Henan Wujian is required to pay Xiangyu Medical a penalty of 1.5 million yuan and compensate for engineering quality repair costs of 419,800 yuan. Meanwhile, Xiangyu Medical is required to pay Henan Wujian an engineering payment of 16.6968 million yuan plus interest, reimburse related expenses of 33,800 yuan incurred from borrowed materials, and return a deposit of 600,000 yuan plus interest. The announcement noted that, based on the final second-instance judgment, the company is obligated to make normal payments for the corresponding engineering fees, reimburse related expenses from borrowed materials, and return the deposit.