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    Home > Active Ingredient News > Drugs Articles > The State Food and Drug Administration announced the second batch of drug rule of law publicity and education bases [three-minute quick overview of one-week medical highlights]

    The State Food and Drug Administration announced the second batch of drug rule of law publicity and education bases [three-minute quick overview of one-week medical highlights]

    • Last Update: 2022-12-30
    • Source: Internet
    • Author: User
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    December 7 - December 13

    December 7 - December 13

    These developments in the pharmaceutical industry are worth paying attention to

    Cover News

    Cover News

    The State Food and Drug Administration announced the second batch of drug rule of law publicity and education bases
    .
    The five companies announced this time are Jiangsu Taizhou Market Supervision Bureau, Jiangxi Zhangshu Drug Administration, Shandong Provincial Food and Drug Administration Policy and Regulation Department, Haikou Market Supervision Bureau of Hainan Province, and Shiquan County Market Supervision Bureau
    of Shaanxi Province.
    The announcement period is from December 9 to 16,
    2022.

    The State Food and Drug Administration announced the second batch of drug rule of law publicity and education bases

    Industry · Policy dynamics

    Industry · Policy dynamics

    1.
    The website of the Drug Evaluation Center of the State Food and Drug Administration announced 13 generic drug consistency evaluation tasks, involving azithromycin and other drugs for injection (as of December 13).

    2.
    The National Pharmacopoeia Commission issued the "About WHO INN Plist127 Publication of Generic Names of Biological Products", which identifies the 125 generic names
    of biological products Chinese included in the World Health Organization (WHO) International Nonproprietary Names (INN) Recommendation Catalogue 127 (Plist127).
    The publicity period is from December 8, 2022 to January 7
    , 2023.

    Product Development · Listing Information

    Product Development · Listing Information

    1.
    The State Food and Drug Administration issued the delivery information of the Phase 1 drug approval certificate, including a total of 37 acceptance numbers, involving Jiangsu Haosen Pharmaceutical Group Co.
    , Ltd.
    and other enterprises (as of December 13).

    2.
    The Center for Drug Evaluation of the State Food and Drug Administration undertook to accept 31 new drug marketing applications, including LBL-033 for injection and other drugs (as of December 13).

    3.
    BeiGene Announces Final PFS Analysis Results of ALPINE Trial, a Global Phase III Head-to-Head Study of Zebratinib (BRUKINSA): In this global Phase III clinical trial for patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), BRUKINSA ® ® achieved superior results against ECO, ® showing more advantageous safety features
    related to cardiac function 。 The findings were presented orally in the latest breakthrough summary session at the 2022 American Society of Hematology (ASH) Annual Meeting on December 14 and published in the New England Journal of Medicine
    .

    4.
    Mengke Pharma announced that its clinical trial application for injectable MRX-4 sequential contizolide tablets for diabetic foot infection submitted by Mengke Pharma in EU countries has been approved recently, allowing clinical trials
    in France, Greece, Hungary, Italy, Latvia, Lithuania, Portugal, Spain and Estonia.

    5.
    Gan & Lee Pharmaceutical issued an announcement that it received the registration approval of insulin glargine injection (prefilled) approved and issued by the Pakistan Drug Administration (approval number: Reg.
    No.
    111178)

    6.
    Bio-thera announced that its marketing application for BAT1806 (tocilizumab) injection biological products submitted to the US Food and Drug Administration (FDA) was accepted
    .

    7.
    Remegen announced that RC118 for injection has obtained two orphan drug approvals issued by the US FDA, respectively for gastric cancer (including gastroesophageal junction cancer) and pancreatic cancer
    .

    Pharmaceutical Company Watch

    Pharmaceutical Company Watch

    1.
    Akeso announces a partnership with British biopharmaceutical company Summit Therapeutics signed a collaboration and license agreement to develop and commercialize
    its bispecific antibody Evosi (PD-1/VEGF, AK112) in the United States, Canada, Europe and Japan.
    Akeso reserves the right to develop and commercialize Ivaci except in the above regions, including in China
    .
    At the same time, Akeso has the co-branded rights
    of the product in the agreement license area of Summit.
    Under the agreement, Akeso will receive a $500 million down payment
    .
    The total value of the transaction, including development, registration and commercialization milestone payments, is expected to reach $5 billion
    .
    Akeso will also receive a low double-digit percentage of net sales as a royalty
    for Ewosi.

    2.
    Shapuai issued an announcement that the company intends to participate in the investment of Jiusong Tangyuan with its own funds as a limited partner, and the company subscribed and contributed 60 million yuan, accounting for 85.
    71%
    of the total subscription of Jiusong Tangyuan.

    3.
    Betta Pharmaceutical issued an announcement that the company intends to invest in Beicheng Investment
    with its own funds.
    The total subscribed capital contribution of Beicheng Investment is 2 billion yuan, and the company will subscribe and contribute 999 million yuan as a limited partner of the partnership, with a subscribed capital contribution ratio of 49.
    95
    %.

    4.
    Dongcheng Pharmaceutical issued an announcement that its subsidiaries Midu Biotech and Gilles Tamagnan, Gu Zhuqin and other sellers signed the Share Purchase Agreement to acquire XING IMAGING, held by the seller, for a transaction amount of US$30.
    2 million (including performance gambling rewards, equivalent to RMB 211 million).
    LLC 100% equity
    .

    5.
    Chengdu Pilot announced that its shareholding subsidiary Xianxian's derivatives intends to raise 65 million yuan, which is led by Yunren Investment, and 11 other investors participate, of which 5 investors are related parties
    of the company.
    Chengdu Pilot waived the pre-emptive subscription right for the capital increase and share increase of the prior derivatives, and after the completion of the capital increase and share increase, the equity ratio held by Chengdu Pilot in the first derivatives decreased from 40% to 29.
    17%.

    6.
    Lizhu Group issued an announcement that it and its controlling shareholder, Health Yuan, originally planned to jointly invest and establish a partnership, but after careful consideration and full discussion by both parties, they have now decided not to establish a partnership and change it to joint investment to establish a joint venture
    .
    Lizhu Group and Health Yuan contributed $600 million and $400 million
    in cash respectively.

    7.
    Meikecom Biologics announced the completion of a B+ round
    of financing of more than 200 million yuan.
    This round of financing was led by GF Qianhe, with the original shareholders China Life Equity Company and New Shang Capital continuing to invest, and the new investors Jiangyuan Investment, Guohai Capital and Guangdong Investment Fund co-investing
    .
    This round of financing will be mainly used for the clinical trials of the company's multiple vaccine pipelines, the construction of Shanghai human vaccine production base, and the expansion and improvement
    of the company's talent team.

    8.
    Xiatong Biotech announced the completion of tens of millions of yuan of angel round financing, which is exclusively invested
    by Danlu Capital.
    Xiatong Biotech mainly develops characteristic nervous system-related stem cell drugs, and is committed to the treatment of demyelinating diseases
    using induced pluripotent stem cells (iPSCs) technology.

    Centralized procurement of medicines

    Centralized procurement of medicines

    1.
    The Medical Insurance Bureau of Shandong Province issued the Notice on Implementing the Results of the Centralized Procurement of the Third Batch of Drugs (Special Projects for Chinese Proprietary Medicines) in Shandong Province.

    The Notice requires that before December 19, 2022, the selected enterprises will list the selected products on the provincial centralized procurement platform for drugs and devices at the selected price, complete the establishment of the distribution relationship, and provide medical institutions to purchase an appropriate amount of selected drugs for stocking; Before December 30, 2022, the municipal medical insurance departments will guide the drug procurement consortium to select and identify medical institutions as representatives, and sign purchase and sales agreements
    with the selected enterprises through the provincial centralized procurement platform for drugs and devices.
    The purchase and sale agreement is signed once a year, and the first year of the procurement cycle is: December 19, 2022 - December 31, 2023
    .
    From January 1, 2023, the results of centralized procurement will be officially implemented, and the selected drugs
    will be sold to patients.

    2.
    Guangdong Provincial Medical Insurance Bureau issued the Notice on Doing a Good Job in the Provincial Procurement and Use of Diclofenac and Other Drugs.

    The Notice requires that the provisions
    of the procurement documents be implemented.
    If diclofenac and other drugs are selected products without increment in the centralized procurement of proprietary Chinese medicines such as Qingkailing, if public medical institutions need to continue procurement after completing the agreed procurement volume in the first year within the procurement year, they shall implement it according to the requirements of independent procurement; Among them, if the exclusive alternative products are innovative drugs, emergency (rescue) drugs, children's drugs, and emergency and shortage drugs in response to public health emergencies, public medical institutions need to confirm by the system before purchasing
    them on demand.

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