October 21, 2020 / Pharmaceutical Information List: Johnson and Johnson two listing applications to be included in the priority review; CRO leading IQVIA in the first three quarters of revenue of more than $8 billion; Nanjing Pharmaceuticals filed for holding subsidiary Liaoning Nan Pharmaceuticals bankruptcy liquidation; Lizhu Pharmaceuticals spin-off Lizhu reagent A shares listed ... Daily fresh medicine news, speed reading society and you pay attention to! Part 1 Policy Brief The Drug Administration adjusts the contents of the Sub-Catalog of 6840 In-body Diagnostic Reagents Classification (2013 edition) Today, the State Drug Administration issued an announcement on the adjustment of the sub-catalog of 6840 In-body Diagnostic Reagents (2013 edition) (No. 112 of 2020).
to adjust the management category and intended use of partial in-body diagnostic reagents with III-7 reagents associated with tumor markers, involving 29 product categories.
(National Drug Administration) CDE: Injection consistency evaluation supplementary information has substantive defects in accordance with the non-approval processing today, CDE issued "on the injection consistency evaluation of supplementary information related matters notice", said that since the chemical generic injection consistency evaluation work, some injection consistency evaluation varieties registration declaration data defects are obvious, with the relevant guidelines require a large gap, need to supplement a large number of new research work.
(CDE) State Drug Administration: 19 from the date of the pilot launch of electronic medical device registration certificate, the State Drug Administration issued a notice on the pilot enablement of electronic medical device registration certificate, from October 19, 2020 to August 31, 2021, the pilot launch of electronic medical device registration certificate, the pilot scope of new approval from the date of the announcement of the domestic third category, import of the second and third categories of first-time registration of medical device registration certificate.
(National Drug Administration) Part 2 watched CRO leader IQVIA's first three quarters of revenue exceeded $8 billion Today, IQVIA, one of the world's leading CRO Leaders, reported third-quarter revenue of $2.786 billion, with revenue from backlog orders growing by more than $400 million to $5.8 billion over the next 12 months.
(Sina Pharmaceutical News) Vifor Pharma and Cara Expanded Advanced Kidney Disease Drug Development Cooperation On October 20, Vifor Pharma and Cara Therapeutics announced that the two companies had signed a commercial license agreement to commercialize Thea's Korsuva (difelikefalin), an injectable drug for chronic kidney disease-related itching (CKD-aP).
(Xinhua) -- On October 20, IN8bio Corp., formerly known as Incysus Therapeutics, announced that it had filed an IPO application with the Securities and Exchange Commission to raise $86 million and land on NASDAQ.
funding will be used primarily to advance clinical trials of the drug candidate drugs INB-200 and INB-100.
(Creative Exchange) Rongchang Bio through the Hong Kong Stock Exchange hearing today, the Hong Kong Stock Exchange website information shows that Rongchang Biopharmaceuticals (Yantai) Co., Ltd. IPO application has passed the hearing, is expected to become the Hong Kong Stock Exchange after the introduction of the New Deal, the 23rd innovative pharmaceutical companies landing on the Hong Kong Stock Exchange.
(Pharmaceutical Rubik's Cube) Nanjing Pharmaceuticals filed for bankruptcy liquidation of Liaoning Nan Pharmaceuticals, a controlling subsidiary, on October 20, Nanjing Pharmaceuticals announced that the board of directors had agreed to apply to the court as a creditor for the bankruptcy liquidation of Liaoning Nan Pharmaceuticals, a controlling subsidiary, on the grounds that Liaoning Nan Pharmaceuticals was insolvent and could not pay off its maturing debts.
(Sina Pharmaceutical News) San Jitang subsidiary bank account 70 million yuan of funds were frozen on October 20, San Jitang announced that recently, the company's wholly-owned subsidiary Yan Chemical finance personnel using Yan Chemical account to pay found that 10 bank account funds were frozen, involving a total of about 70.1488 million yuan, accounting for the company's most recent fiscal year audited net assets of 2.21%.
(Sina Pharmaceutical News) Ruikang Pharmaceuticals and AstraZeneca signed a memorandum of strategic cooperation October 19, Ruikang Pharmaceuticals announced that it and AstraZeneca signed a Memorandum of Strategic Cooperation, the two sides will work together on the construction of medical associations, hospital access, expansion of the end market and other work.
(Cypress Blue) Lizhu Pharmaceuticals spin-off Lizhu Reagent A-share listed Health Yuan and Lizhu Group announced on October 19 that the Hong Kong Stock Exchange has agreed to the lizhu Group spin-off of its subsidiary Zhuhai Lizhu Reagent Co., Ltd. A-share listing.
, after the completion of the market, Lizhu reagents will be mainly engaged in diagnostic reagents and equipment research and development, production and sales.
(E drug manager) Part 3 drug information Merca East V114 two Phase 3 clinical trial results positive today, Merca East announced that it is in the study of 15-price streptococcus pneumoniae vaccine V114, in two phase 3 clinical trials called PNEU-PATH (V114-016) and PNEU DAY (V114-017).
(Pharmaceutical Mingkangde) Johnson and Johnson CD38 single anti-ion two listing applications to be included in the priority review today, CDE website latest publicity, Johnson and Johnson's Jansen company developed CD38 monoclonal antibody Daleitoyu single anti-injection two listing applications were included in the proposed priority review varieties.
(Pharmaceutical Mission) Isaac Lunvatini's 2nd adaptive disease will be approved recently, Japan's Azo Lunvatini 2nd adaptive disease listing application changed to "in approval", is expected to be approved for the near future listing, for the treatment of differentiated thyroid cancer.
(CPhI Pharmaceuticals Online) NMDA regulator PTSD shows early efficacy Today, U.S. biotech company Aptinyx announced that its NMDA regulator NYX-783 has shown some efficacy in a Post traumatic Sequelae (PTSD) Phase II clinic.
(U.S. and Chinese medicine source) Hai wang biology: HW130 injection to obtain drug clinical trial approval notice today, Shenzhen Hai wang bioengineering Co., Ltd. issued a notice that its wholly-owned subsidiary Shenzhen Hai wang Pharmaceutical Science and Technology Research Institute Co., Ltd. recently received the State Drug Administration approved the issuance of the "drug clinical trial approval notice."
the HW130 injection with a strong solution will conduct clinical trials of advanced malignant solid tumors and multiple myelomas.
(Sina Pharmaceutical News) Kanghong Pharmaceuticals: Hydrochloric acid Zuminaplun slow release capsule clinical trial was approved by NMPA today, Chengdu Kanghong Pharmaceutical Company announced that the company recently received the State Drug Administration issued on the hydrochloric acid Zuminaplun slow release capsule "drug clinical trial approval notice."
notice showed that the hydrochloric acid zuminaplun slow-release capsule met the requirements for drug registration and agreed to conduct human bioethic equivalent trials and validated clinical trials for depression.
(Sina Pharmaceutical News) Yiming Anke VEGF/PD-L1 dual-specific antibody clinical application was accepted by CDE today, CDE latest publicity, Yiming Anke Class 1 bio-new drug injection IM2510 clinical application was accepted.
is a dual-specific antibody that can target both VEGF and PD-L1 and is intended to be developed for use in solid tumors.
this is the first time the product has been declared clinical in China, yiming Anke after the IMM01 project and IMM0306 project, the third project to submit clinical applications.
(Pharmaceutical Mission) Blue Sail Medical Cobalt Chromium Alloy 2nd Generation Crown Bracket received a CE certificate on the evening of October 20th, BlueFan Medical announced that the company recently received the certification bulletin body DEKRACertification B.V. issued the cobalt Chromium 2nd generation upgraded crown stent BioFreedom Ultra CE certificate.
(Sina Pharmaceutical News) National Medicine 2 inactivated vaccines are included in the scope of emergency use October 20, the State Council joint prevention and control mechanism held a press conference, the Ministry of Foreign Affairs, Ministry of Science and Technology, Health Commission, Drug Administration and other relevant officials and experts to introduce the progress of research and development of the new crown vaccine, follow-up vaccination methods and other related information.
(Pharmaceutical Rubik's Cube) Hengrun Dasheng's first CD19/CD22 dual-target CAR-T declaration was accepted on October 20, Zhangjiang Science City cell therapy enterprise Shanghai Hengrun Dasheng Biotech Co., Ltd. the first CD19-CD22 dual-target CAR-T drug clinical trial application was accepted by NMPA.
, Hengrun Dasheng has received a total of 3 CAR-T clinical approvals, targeting CD19 and BCMA.
(Medical Valley) Kexing New Corona inactivated vaccine in Phase 3 clinical trials to obtain positive mid-term safety data, the Butantan Institute in Brazil announced that by Beijing Kexing Zhongwei Biotechnology Co., Ltd. jointly developed by a number of partners of the new coronal inactivated vaccine CoronaVac in the phase 3 clinical trials in the medium-term analysis, showing good safety data.
(Pharmaceutical Mingkangde) Xinlitai hydrochloric acid dapositin tablets will be approved on October 18, Xinlitai declared the four classes of generic drug hydrochloric acid dapositin tablets market applications into the "in the approval" stage, is expected to be approved in the near future.
(Medical Rubik's Cube)