Points of medicine every week (6.29-7.5)

Industry policy dynamics

1. The State Health and Health Commission and the State Drug Administration jointly issued the "Plan for Clinical Urgent Pharmaceutical Importation Work Plan" (hereinafter referred to as the "Plan") to further improve the drug supply guarantee policy and meet the needs of specific clinical needs of the masses. The "Temporary Import Work Plan" is released at the same time as an individual scheme for temporary imported drugs. The "Plan" is suitable for overseas markets that have no registered listing, non -enterprise production, or in short -term, and a small amount of drugs have been urgently needed to be listed abroad. Among them, a small amount of drugs in the clinical urgent need of a small amount of drugs include drugs used to treat rare diseases; drugs that are used to prevent severe life diseases and do not have effective treatment or preventive methods; drugs that are used to prevent severe life diseases and have obvious clinical advantages.

2. The State Drug Administration issued the "Supporting Hong Kong and Macao Pharmaceutical License License Owners in the Mainland Municipal Production Pharmaceutical Implementation Plan in the Mainland in the Greater Bay Area" and "Supporting Hong Kong and Macao Medical Device Registers in the Mainland Municipal Production and Device Implementation Plan in the Greater Bay Area", Promote the reform of the Guangdong -Hong Kong -Macao Greater Bay Area Pharmaceutical Local Pharmaceutical License and Medical Device Registration system, further promote the deep integration of the biomedical industry of the Guangdong -Hong Kong -Macao Greater Bay Area, and achieve the common development of the pharmaceutical industry in the Guangdong -Hong Kong -Macao Greater Bay Area.

3. The State Drug Administration issued the Catalog of the Victory Drug Reference Preparation (55th Batch), involving drugs such as nitroglycerin spray.

4. The Comprehensive Department of the State Drug Administration and the General Office of the General Administration of Customs jointly issued a notice to add the Chongzuo Store Port in the Guangxi Zhuang Autonomous Region as the medicinal port port.

5. The Drug Review Center of the State Drug Administration (CDE) publication chemical generic drug reference preparations (60 batch), involving drugs such as Lamifidido, and other medicines. The publicity period is July 5, 2022 - 18.

Product research and development/listing information

1. The State Drug Administration approved the first type of innovative drugs (product name: Kenda/kener) to be listed on the market. This drug is suitable for adult patients with chronic kidney disease related to type 2 diabetes (the estimation value of glomerular filtration rate [EGFR] 25 to <75 ml/min/1.73 m2, accompanied by albuminuria), which can reduce the continuous decline in EGFR and decline, and The risk of ending renal disease.

2. The State Drug Administration approves the first type of innovative drugs (commodity name: Ereyn) reported by Jiangsu Hengrui Pharmaceutical Co., Ltd. to approve the application of the priority review and approval procedure. The drug is suitable for patients with metastatic hormone -sensitive prostate (MHSPC) patients with high tumor load.

3. The State Drug Administration approves Kangfang Pharmaceutical Co., Ltd. Kangfang Pharmaceutical Co., Ltd. Kangfang Pharmaceutical Co., Ltd. Kangfang Pharmaceutical Co., Ltd. The drug is an innovative bispecifier antibody independently developed in my country, which is suitable for the treatment of recurrence or metastatic cervical cancer patients that previously received platinum chemotherapy.

4. The State Drug Administration issued a three -phase pharmaceutical approval certificate to receive information, including 219 acceptance numbers, involving companies such as Shanghai Shang Pharmaceutical First Biochemical Pharmaceutical Co., Ltd. (As of July 5)

5. CDE website publicize 22 consistency evaluation tasks, involving drugs such as sulfate injection. (As of July 5)

6. CDE has held 52 new drug listing applications, including reorganized humanized PDL1/CTLA-4 bispectoral single-domain antibody FC fusion protein injection and other drugs. (As of July 5)

Observation of pharmaceutical enterprises

1. Junshi Bio announced that it and partner Runjia Pharmaceutical received notice from the US Food and Drug Administration (FDA). Remark (HR) positive, human epidermal growth factor receptor-2 (HER-2) negative, PIK3CA mutation advanced or metastatic breast cancer women (postmenopausal) and clinical trial applications for male patients obtained FDA approval.

2. Yasheng Pharmaceutical announced that it was originally innovatively innovated in the outer embryo outer embryo outer germin development protein (EED) inhibitor APG-5918 obtained the American FDA clinical trial permit. Safety, pharmacokinetics and efficacy.

3. Fosun Pharmaceutical Holding subsidiary Fushong Hanlin signed the "Cooperation and License Agreement" with the American Palleon Company. Based on their own patents and proprietary technologies, the two parties will develop product dual-function HER2-salivary acid enzyme fusion protein, and Another tumor -related target -related target saliva acid enzyme dual -function fusion protein developed by the two parties will cooperate in the field (that is, for the treatment of human diseases).

4. Xingqi Eye Medicine issued an announcement stating that it was planned to sign the "Project Investment Agreement" with the Shenyang District Management Committee of China (Liaoning) Pilot Zone with China (Liaoning). The total investment of the project was 637 million yuan. Xingqi Eye Pharmaceutical intends to invest in batches within the policy period (5 years). The investment content includes but is not limited to the construction of the Xingqi Ophthalmology R & D Center and the development of drugs.

5. Dorui Pharmaceutical issued an announcement stating that it is planned to subscribe for 526,800 shares issued by Hairong Pharmaceutical at 47.46 yuan/share price, and the total investment is expected to exceed 25 million yuan.

6. Washinga Gene issued an announcement stating that it will be used as a limited partner to invest 200 million yuan in its own funds to participate in the subscription of Xiamen Yuanfeng Equity Investment Fund Partnership (Limited Partnership) and other value assets.

7. Xinhua Pharmaceutical and the Institute of Pharmaceuticals of the Chinese Academy of Medical Sciences signed the "Technical Transfer (Patent Right) Contract" on the innovative drug "LXH-2201 Materials Drug and its preparation". The latter will be exclusively transferred to Xinhua Pharmaceutical, the technical ownership of the project and the patent rights, patent application rights and post -development rights, product reporting, production, sales (domestic and international markets) related to the project. 8. Chengdu Pioneer and Chengdu Jizhichuchuchuang and Hainan Guiying intend to jointly invest in the establishment of Chengdu Xianli Biotechnology Co., Ltd. (tentative name, the specific name is subject to the final approval of the company's registration authority), and the registered capital is 10 million yuan. Project development and related technologies for nucleic acid drugs. Among them, Chengdu introduced 4 million yuan, accounting for 40%of the total registered capital; Jizhike founded 500,000 yuan, accounting for 5%of the total registered capital; Essence

9. Enkai Yaoshi announced the completion of more than 100 million yuan in Series A financing. This round of financing is led by Huagai Capital. The Chinese Academy of Sciences Venture Capital, Capital Fund, Chengyi Capital, Sirius Capital, Qiao Jing Capital, etc. will be used for the research and development of a series of NK cell drug product pipelines in different stages.

10. Knowing that Yi Bio announced the completion of B ++ round of financing of RMB 100 million. Investors include SDIC and Entrepreneurship, Guangzhou Development Zone Fund, and Chuangxing Group, etc., and financing funds are mainly used to accelerate the clinical development of its new drug pipelines.

11. Tajiri Bio announced the completion of hundreds of millions of yuan B financing. This round of financing was led by Dinghui Baifu. The original shareholders Jianyin International, Shenzhen Venture Capital, and Oriental Fuhai continued to follow the investment. This round of financing funds will be mainly used to promote the key clinical trials of BCR-ABL1 transformers TGRX-678 and ALK/ROS1 inhibitors TGRX-326, as well as the company's other innovative drugs in the company.

Pharmaceutical concentrated procurement

1. Shanghai Sunshine Pharmaceutical Procurement Network announced the results of the centralized procurement of the Pharmaceutical Pharmaceutical Procurement of the Yangtze River Delta (Shanghai -Zhejiang and Anhui). This time, a total of 47 varieties, and the average drug price of the three provinces decreased by about 26%. The specific execution date will be announced separately.

2. Jilin Provincial Public Resources Exchange Center issued the "Announcement on the Pharmaceutical Purchase of Public Medical Institutions in Jilin Province". The scope of bidding involved in this collection includes medicines that have not been traded on the Jilin Provincial Public Resources Trading Platform, and the drug registration approval time after the pharmaceuticals after January 1, 2021 (including the day of the 1st) Drug re -registration (including drug supplementary approval) time after January 1, 2021. Among them, the drugs that are concentrated and used by the National Organization of Drugs (including the seventh batch of national organizational drugs in the same name, the same dosage -type medicine), shortage drugs, maternal specialty and emergency rescue drugs, national and emergency rescue drugs, national and emergency rescue drugs published by the state and provincial departments During the negotiating drug (during the agreement period), the state negotiating drug (during the agreement period), the generic drugs, and the basic infusion are available in accordance with the existing regulations. Anesthesia drugs and psychiatric drugs are implemented in accordance with national regulations and are not within the scope of the bidding.

Source: China Food and Drug Network

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