I-Mab Licenses Greater China Rights for CD73 Antibody Uliledlimab to Sanofi in Deal Worth Up to €213 Million

Sep 26, 2024 19:02 CST Updated 19:02

Johnson & Johnson

Medical Device R&D and Manufacturer

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

Sanming Procurement Alliance Holds the "Six Diseases Joint Management" Medication (First Batch) Centralized Procurement Work Conference

On September 24, the Sixth Joint Conference of the Sanming Procurement Alliance and the Launch Conference for the "Six-Disease Co-Management" Drug Initiative (First Batch) was held in Sanming City. The procurement plan for the "Six-Disease Co-Management" drugs (First Batch) by the Sanming Procurement Alliance was discussed, and after revisions and adjustments to the procurement plan, the procurement documents will be issued. During this conference, 10 cities (prefectures) in Heilongjiang Province signed the agreement to join the Sanming Procurement Alliance (China) with Sanming City.

21 Comments: The Sanming Alliance's centralized procurement of medicines for diseases such as cancer and respiratory conditions is one of the key national joint procurement initiatives guided by the National Healthcare Security Administration in 2024. With the addition of 10 cities (regions) in Heilongjiang Province, the coverage of the Sanming Procurement Alliance has expanded once again. The aforementioned meeting also emphasized that the Sanming Procurement Alliance will broaden the scope of its reforms, promote regular cross-regional joint procurement, and continuously reduce the inflated prices of medicines and consumables.

Pharmaceutical and Medical Device Approval

Haihe Pharmaceutical's Imported Oral Paclitaxel Approved in China

On September 25, the latest announcement on the official website of the China National Medical Products Administration (NMPA) revealed that the marketing application for a Class 5.1 new drug, paclitaxel oral solution, jointly submitted by South Korea's Daehwa Pharmaceutical and Haihe Pharma, has been approved. Public information indicates that this oral paclitaxel formulation (development code: RMX3001), developed collaboratively by Daehwa Pharmaceutical and Haihe Pharma, is primarily based on the results of a Phase 3 clinical study for second-line treatment in gastric cancer patients.

Rui Kang Di Pharmaceutical's Application for Cushing's Syndrome Innovative Drug Approved in China

On September 25, the latest announcement on the official website of the China National Medical Products Administration (NMPA) revealed that the marketing application for osilodrostat phosphate tablets (formerly known as osilodrostat), submitted by Recordati Group's wholly-owned Chinese subsidiary Rongkangdi Pharmaceuticals, has been approved. According to the priority review disclosure by the Center for Drug Evaluation (CDE) under the NMPA, the approved indication for this drug is: treatment of endogenous Cushing's syndrome in adults.

Johnson & Johnson's New Lung Cancer Bispecific Antibody Drug and New Formulation Submitted for Marketing Approval in China

On September 25, the CDE website just announced that the marketing application for Johnson & Johnson's amivantamab injection (subcutaneous injection) has been accepted. Public information shows that this is a fixed combination of Johnson & Johnson's EGFR/MET bispecific antibody amivantamab and recombinant human hyaluronidase for subcutaneous administration. According to the press release, patients can complete the injection of this subcutaneous formulation in five minutes.

Humanwell Healthcare Subsidiary's Drug Marketing Authorization Application Accepted

On September 25, Renfu Pharmaceutical announced that its holding subsidiary, Yichang Renfu Pharmaceutical, received the "Acceptance Notice" for the registration and market approval application of the Citrate Fentanyl Oral Patch issued by the National Medical Products Administration. This medicine is applicable for treating breakthrough pain in adult cancer patients who continuously use opioid drugs. To date, Yichang Renfu's cumulative R&D investment in this project is approximately 30 million yuan. In 2023, the sales revenue of all forms of fentanyl preparations in China's public hospitals was about 330 million yuan.

Saint-Ray Biotech Human Papillomavirus Nucleic Acid Detection Kit Approved

On September 25, Saint-Ray Biotech announced that its product, the Human Papillomavirus Nucleic Acid Detection Kit, recently received a medical device modification registration document issued by the National Medical Products Administration, officially approved for additional intended uses including primary cervical cancer screening, combined cervical cancer screening, and ASCUS triage.

Hengrui Medicine Subsidiary's Fluorine [18F] Metathesone Injection Receives Clinical Trial Approval

On September 25, Hengrui Medicine announced that its subsidiary, Tianjin Hengrui Medicine, received the "Drug Clinical Trial Approval Notice" for [18F]Flutemetamol Injection issued by the National Medical Products Administration, approving the clinical trial for positron emission tomography imaging to assess the density of neuritic plaques formed by β-amyloid aggregation in the brains of adult patients with cognitive impairment caused by Alzheimer's disease or other reasons. The cumulative R&D investment for this drug is approximately 22.88 million yuan.

Capital Market

Zhou Zhiwen, Related Party of Staidson, Plans to Increase Investment and Expand Shares in Sannu Jiayi

On September 25, Staidson announced that the company and Mr. Zhou Zhiwen plan to increase capital and expand shares in Staidson's wholly-owned subsidiary, Sannu Jiayi. Mr. Zhou Zhiwen will subscribe to the newly added registered capital of Sannu Jiayi, and after the completion of the capital increase, his shareholding ratio will be 49%. This transaction constitutes a related party transaction and still needs the approval of the shareholders' meeting. The aim of this transaction is to better support the company’s development, aligning with its strategic planning, and will not have a significant impact on the company’s financial condition and production operations.

Industry Highlights

Tianjing Biopharma CD73 Antibody China Rights Granted to Sanofi

On September 25, I-Mab announced a strategic collaboration with Sanofi regarding the development, manufacturing, and commercialization of uliledlimab, an innovative CD73 antibody independently developed by I-Mab, in Greater China. Sanofi will pay I-Mab an upfront payment and near-term milestone payments totaling approximately €32 million (about RMB 250 million), as well as specific registration and sales milestone payments, with a potential total consideration of up to €213 million (approximately RMB 1.7 billion). Meanwhile, Sanofi will obtain exclusive rights to develop, manufacture, and commercialize uliledlimab in mainland China, Hong Kong, Macau, and Taiwan.

Belief BioMed Reaches Collaboration and Development Agreement with Asklepios

On September 25, Belief BioMed announced a strategic partnership with Asklepios BioPharmaceutical, Inc. to jointly explore the potential of innovative gene therapies. According to the contract terms, both parties will combine their expertise and strengths in gene therapy technology to conduct in-depth research and exploration into disease areas that could benefit from innovative gene therapy solutions via liver-targeting treatment approaches.

Positive Efficacy Signal Observed in APL-1202 Combined with Tislelizumab for MIBC Treatment by YAHONG Pharmaceuticals

On September 25, Asieris Pharmaceuticals announced that the Phase Ⅰ/Ⅱ clinical trial of APL-1202 oral administration in combination with tislelizumab as neoadjuvant therapy for MIBC has completed Phase II and demonstrated positive efficacy signals. The results showed that, compared to the tislelizumab monotherapy group, the combination therapy group achieved a pCR rate of 41% in mEAS, while the monotherapy group had a rate of 20%. These trial results provide strong support for the company’s further development of APL-1202 in combination with immune checkpoint inhibitors for bladder cancer treatment.

Sanxin Medical Plans to Invest 500 Million Yuan in Building High-Performance Blood Purification Equipment and Supporting Consumables Industrialization Project

On September 25, Sanxin Medical announced that the company plans to invest approximately 500 million yuan of its own funds and bank loans to construct the "Industrialization Project of High-Performance Blood Purification Equipment and Matching Consumables" in the Xiao Lan Economic Development Zone, Nanchang County, Jiangxi Province. The project aims to enhance the production capacity of new products such as blood purification equipment for critical care treatment and matching tubing consumables, as well as needle-free injection systems for diabetes and matching ampoule consumables.

Public Opinion Early Warning

Guizhou Sanli Shareholder Guosheng Haitong Private Enterprise High-Quality Development Fund Reduces Stake to Below 5%

On September 25, Guizhou Sanli announced that the Guosheng HAITONG Private Enterprise High-Quality Development Fund, a shareholder holding more than 5% of the company's shares, reduced its holdings by 9,900 shares through centralized bidding on the Shanghai Stock Exchange, accounting for 0.002416% of the company’s total share capital. This reduction caused its shareholding ratio to drop to 4.999997%, and it is no longer a shareholder with more than 5% of the shares. This equity change does not trigger a tender offer and will not lead to a change in the company’s actual controller.