I. policy trends
● "jingyitong" operator's announcement: the normal operation of the system will be guaranteed during the negotiation
On April 18, a document about "Beijing Yitong will be shut down" circulated on the Internet. The signature of the document is Beijing Yihe Spring Technology Co., Ltd. In response, on the 19th, the Beijing Municipal Health Commission responded that Beijing Yihe Spring Technology Co., Ltd., as the operator of the Beijing Medical online system, had a dispute with the investor Bank Of Beijing Co.Ltd(601169) . The Beijing Municipal Health Commission and the Beijing hospital management center have paid attention to the matter in the early stage and guided the parties to actively resolve the dispute.
Subsequently, Beijing Yihe Spring Technology Co., Ltd., the operator of "jingyitong" online system, announced late on the 19th that the company had communicated with Bank Of Beijing Co.Ltd(601169) the investor of "jingyitong" through the active coordination of Beijing Municipal Health Commission, Beijing hospital management center and other relevant departments. In the follow-up, under the supervision and guidance of relevant government departments, the two sides will negotiate with a rational attitude on the historical investment and future operation funds of the "jingyitong" online system, so as to promote the final settlement of all problems. The announcement said that during the negotiation between the two sides, Beijing Yihe Spring Technology Co., Ltd. will ensure the normal operation of the "jingyitong" online system and continue to strive to provide high-quality services for the majority of "jingyitong" users.
II. Approval of pharmaceutical equipment
● stanza bio car-t product has obtained FDA fast track qualification
On the 19th, stansay biology announced that the US FDA has granted gcc19cart fast track qualification. Gcc19cart is an autologous car-t treatment product targeting GCC. It is a solid tumor therapy developed by stansay biology for the treatment of recurrent, refractory and metastatic colorectal cancer.
● conoya biological ADC drug has obtained the fast track qualification of FDA
On April 19, konoya Biomedical Technology Co., Ltd. announced that its new drug cmg901 under development for the treatment of recurrent / refractory gastric cancer and gastroesophageal junction adenocarcinoma (GC / gejc) has recently been granted fast track qualification (FTD) by the US FDA. Previously, cmg901 was approved by FDA for clinical trials in March 2021 and was certified as orphan drug in April 2022. Cmg901 is an antibody coupled drug (ADC) targeting claudin 18.2. It contains claudin 18.2 specific antibody, cleavable linker and toxicity load methylaurestatin e (MMAE). It is the first claudin 18.2 antibody coupled drug that has been approved for clinical trials in China and the United States. Claudin 18.2 is highly expressed in gastric cancer, pancreatic cancer and other solid tumors, making it an ideal target for cancer therapy.
● Jinshi biological cardiac surgery biological patch approved for marketing in China
On the 18th, Jinshi biological announced that its self-developed cardiac surgery biological patch elite air was certified by the State Food and Drug Administration of China and approved for sale for cardiac surgery to repair ventricular septal defect.
III. capital market
● Yuanxin technology update prospectus
Beijing Yuanxin Technology Group Co., Ltd. submitted an updated prospectus to the Hong Kong Stock Exchange on April 19, with Goldman Sachs and Citic Securities Company Limited(600030) as co sponsors.
This means that after updating the materials and data according to the requirements of the Hong Kong stock exchange, Yuanxin technology continues to promote the IPO. On March 18 this year, Yuanxin technology has obtained the "main road" for its listing in Hong Kong from the CSRC.
● Jingfeng medical submitted the prospectus to the Hong Kong Stock Exchange
Shenzhen Jingfeng Medical Technology Co., Ltd. officially submitted a prospectus to the Hong Kong Stock Exchange on April 19, and planned to be listed on the main board. Morgan Stanley, CICC and Citigroup served as co sponsors.
Established in 2017, Jingfeng medical is a fast-growing surgery Siasun Robot&Automation Co.Ltd(300024) enterprise. It has launched key clinical trials of multi hole and single hole endoscopic surgery Siasun Robot&Automation Co.Ltd(300024) in China and one of the only two companies in the world. Jingfeng medical has completed the design and main research and development of Jingfeng multi hole endoscopic surgery Siasun Robot&Automation Co.Ltd(300024) mp1000 and Jingfeng single hole endoscopic surgery Siasun Robot&Automation Co.Ltd(300024) sp1000 in 4 years. Both mp1000 and SP1000 are qualified for the rapid examination of Innovation Medical Management Co.Ltd(002173) devices by the State Food and drug administration through the green channel.
IV. industry events
● world's first PI3K δ/ CK1 ε Withdrawal of listing application of inhibitors
Recently, TG therapeutics announced to voluntarily withdraw the biological agent license application / supplementary new drug application of U2 combination ukoniq (umbralisib) combined with ublituximab in the treatment of adult patients with chronic lymphocytic leukemia and small lymphocytic lymphoma. The decision to withdraw was based on the recently updated overall survival data of the phase III unit-cll trial.
In addition, the company also voluntarily stopped selling ukoniq, which means that the company's only product will also withdraw from the market. In February 2021, ukoniq was accelerated by FDA for the treatment of adult patients with recurrent or refractory marginal zone lymphoma (MZL) who had previously received at least one anti-CD20 based treatment regimen and adult patients with recurrent or refractory follicular lymphoma (FL) who had previously received at least three-line systemic treatment. Ukoniq is the first and only once daily oral inositol phosphate 3 kinase (PI3K) approved for marketing δ And casein kinase 1 (CK1) ε Inhibitors.
● Roche joins hands with TIVA to promote the accessibility of bendamostin in China
Roche pharmaceutical China announced an innovative cooperation agreement with Teva, a well-known pharmaceutical enterprise in Israel. The two sides will integrate their advantageous resources and further expand the accessibility of bendamostine hydrochloride (trade name: Cunda) in China. Through this cooperation, Roche pharmaceutical China will further enrich the product pipeline in the field of blood tumor, expand the panorama of lymphoma treatment, and continue to work with all parties to promote the standardized diagnosis and treatment of lymphoma in China. Cunda is the original bendamostine hydrochloride independently developed by Teva company. It was approved in China in 2018 to treat inert B-cell non-Hodgkin lymphoma (NHL) with disease progression during / after treatment with rituximab or rituximab containing regimen. This cooperation between Roche and Teva will lay a solid foundation for Cunda to use Roche's original innovative drugs Jialuohua (Chinese common name: altuzumab vedotin) and vepotuzumab (English common name: polatuzumab vedotin), give play to the synergistic effect of the original drugs, and bring good survival benefits to the majority of Chinese patients with lymphomas.
