Source | 21st Century Business Herald
Edited by Ji Yuanyuan, Xu QiulianWelcome to join the New Health team of 21st Century Business Herald in focusing on the latest events in the pharmaceutical and healthcare industry!
Policy Trends
On September 4, the National Healthcare Security Administration (NHSA) announced that Shi Zihai, a member of the Party Leadership Group and Deputy Director of the NHSA, led a team to Tianjin to conduct research on the national centralized procurement of high-value medical consumables. During the visit, he emphasized the need to accelerate the new round of national centralized volume-based procurement (VBP) for high-value medical consumables, expand the procurement scope to include items such as cochlear implants, fully consider market dynamics and clinical characteristics of these consumables, and refine VBP rules through a “one product, one policy” approach. Efforts should be made to ensure the effective implementation of the winning bid results from the fourth batch of consumable VBP and the follow-up procurement for artificial joints upon expiration of existing contracts. Measures must be taken to guarantee the timely entry of winning products into hospitals, guide and supervise medical institutions to prioritize the procurement of these products, and ensure that the public genuinely benefits from these initiatives.
Drug and Medical Device Approval
On September 4, the CDE website indicated that pembrolizumab had a new indication submitted for market approval in China. Industry forecasts suggest that this submission may be for the combination of pembrolizumab with chemotherapy for the treatment of unresectable, advanced, or recurrent malignant pleural mesothelioma. Previously, Merck & Co. announced the results of the Phase III KEYNOTE-483 trial, which demonstrated that Keytruda (pembrolizumab) combined with chemotherapy, as a first-line treatment for unresectable advanced pleural mesothelioma, significantly improved overall survival compared to chemotherapy alone.
- Innovent Bio’s Bispecific Antibody Cancer Drug Receives FDA Fast Track Designation
On September 4, Innovent Bio announced that its PD-1/IL-2α-bias bispecific antibody fusion protein, IBI363, has been granted Fast Track Designation (FTD) by the U.S. FDA. The proposed indication is for locally advanced or metastatic melanoma (excluding choroidal melanoma) that has progressed following at least one prior line of systemic therapy containing a PD-1/L1 checkpoint inhibitor. Currently, Innovent Bio is concurrently conducting Phase 1/2 clinical studies in China, the United States, and Australia to evaluate the efficacy and safety of IBI363 in various advanced malignant tumors.
- Hybio Pharmaceutical’s Somatostatin API Receives CEP Certificate
On September 4, Hybio Pharmaceutical announced that its somatostatin active pharmaceutical ingredient (API) had been granted a Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP) by the European Directorate for the Quality of Medicines & HealthCare (EDQM), with a validity period of five years. The issuance of this CEP certificate will facilitate market access for the company’s API in the European Union, support the expansion of its overseas markets, and have a positive impact on its operational performance.On September 4, the Shanghai Stock Exchange (SSE) disclosed that, due to the withdrawal of the issuance and listing application by Shandong Branden Medical Devices Co., Ltd. and its sponsor, the SSE has terminated the review of its issuance and listing in accordance with the relevant provisions of Article 63 of the Rules for the Review of Stock Issuance and Listing on the Shanghai Stock Exchange.
Industry Highlights
On September 4, EpimAb Biotherapeutics and Vignette Bio announced that they had entered into a licensing agreement for EMB-06, EpimAb’s T-cell engager (TCE) molecule targeting BCMA.Pursuant to the agreement, EpimAb Biotherapeutics will grant Vignette exclusive rights to develop and commercialize EMB-06 outside the Greater China region (including mainland China, Hong Kong, Macau, and Taiwan), while EpimAb Biotherapeutics will retain the rights to EMB-06 within the Greater China region. EpimAb Biotherapeutics will receive an upfront payment totaling USD 60 million in the form of cash and equity in Vignette, and will be entitled to receive up to USD 575 million in development, regulatory approval, and commercialization milestone payments, as well as royalties based on net sales.21 Commentary: Currently, T-cell engager (TCE) bispecific antibodies have achieved breakthroughs in the fields of hematologic malignancies and solid tumors, with their potential in autoimmune diseases also beginning to attract attention. In recent years, TCE bispecific antibodies have become one of the areas most deeply explored by Chinese pharmaceutical companies, with Chinese-made TCE bispecific antibodies frequently going global and commanding substantial deal values. A month ago, Merck & Co. invested $1.3 billion to license Tongrun Bio’s CD3/CD19 bispecific antibody, CN201.
On September 4, Qidi Pharmaceutical announced that on September 3, 2024, the Company received notification letters from Tan Yunliang and Wang Zhong, shareholders of Mingshi Pharmaceutical, stating that due to reasons attributable to the transferors themselves, they had decided to unilaterally terminate cooperation with the Company and rescind the "Share Transfer Agreement" signed by both parties on February 28, 2024. The transferors committed to refunding the already received share transfer payment of RMB 42.405 million within seven working days from the date of service of the notice.
