"Pharmaceutical Speed ​​Reading Club" Takeda Natpara is short of cefuroxime, arkamicin...

[April 7, 2021/Medical Information List] Revised instructions for cefuroxime and arkamicin; Microchip Biotech "Cioroni Capsules" launched Phase III clinical trials for small cell lung cancer; Hengrui HR19042 capsules were approved It is used to treat primary IgA nephropathy; Takeda's 100 microgram dose of Natpara will be cut off for 1 year.

[April 7, 2021/Medical Information List] Daily news about fresh medicines and medical news, speed reading and follow you together!

Part 1 Policy Brief

Part 1 Policy Brief Part 1 Policy Brief

Quotations from 265 pharmaceutical companies with 57 large varieties

Quotations from 265 pharmaceutical companies with 57 large varieties

According to the "Notice on Carrying out Online Bargaining for the Sixth Batch of Guangxi Pharmaceutical Group Procurement (Second Batch) Varieties" issued by the Guangxi Pharmaceutical Group Procurement Service Platform, the Joint Procurement Office has determined the varieties and participating companies of this batch, which is scheduled for 2021 Online bargaining will be carried out on April 7.

Implementation of the results of collection of 8 major varieties

Implementation of the results of collection of 8 major varieties

The Hubei Provincial Pharmaceutical Price and Bidding Procurement Management Service Network issued the "Notice on the Implementation of the Results of the Centralized Procurement of 8 Varieties of Paroxetine Oral Constant-Release Dosage Forms", and expanded Hubei Province’s implementation of the state-organized centralized drug procurement pilot for paroxetine oral ordinary-release dosage forms, etc.

Revised instructions for cefuroxime and arkamicin

Revised instructions for cefuroxime and arkamicin

On the 6th, the State Food and Drug Administration issued two announcements to revise the instructions for oral and injection preparations of cefuroxime and amikacin injection.

The price of 32 product regulations is lowered, Qilu, Chia Tai Tianqing, Eli Lilly and other well-known drugs are listed

The price of 32 product regulations is lowered, Qilu, Chia Tai Tianqing, Eli Lilly and other well-known drugs are listed

The Jiangsu Provincial Public Resources Trading Center issued a notice on adjusting the prices of some medicines.

Part 2 Observation of Sankei

Part 2 Sankei Observation Part 2 Sankei Observation

Jointown employee representative supervisor Chen Li resigns

Jointown employee representative supervisor Chen Li resigns

Jointown announced that on April 5, the board of supervisors received a written resignation report from the company's employee representative supervisor Chen Li.

Takeda's 100 microgram dose of Natpara will be withdrawn for 1 year

Takeda's 100 microgram dose of Natpara will be withdrawn for 1 year

Takeda announced in an open letter to the Hypoparathyroidism Association and the broader hypoparathyroidism patients and the medical community that 100 micrograms of Natpara may be interrupted as early as this week due to shortage of supply.

Sansheng Guojian and Immune Onco cooperate to carry out the clinical study of Septopin combined with IMM01

Sansheng Guojian and Immune Onco cooperate to carry out the clinical study of Septopin combined with IMM01

Sansheng Guojian issued an announcement stating that it recently signed a "Combination Drug Development Cooperation Agreement" with ImmuneOnco to jointly promote the combination therapy of anti-HER2 monoclonal antibody ceptin (initumumab) and anti-CD47 fusion protein IMM01 in China The clinical development and commercialization of (Sina Pharmaceutical News)

Up to $1.

Up to $1.

Part 3 Drug News

Part 3 Drug News Part 3 Drug News Information

Bayer plans to announce iNHL Phase III clinical data and its combined oncology study

Bayer plans to announce iNHL Phase III clinical data and its combined oncology study

According to foreign media reports, Bayer plans to showcase its new research in the field of oncology at the virtual American Association for Cancer Research (AACR) annual meeting in 2021.

Microchip's "Cioroni Capsule" launches Phase III clinical trial for small cell lung cancer

Microchip's "Cioroni Capsule" launches Phase III clinical trial for small cell lung cancer

According to the Insight database, Microchip Biologics Cioroni Capsules has initiated a phase III clinical trial for the treatment of small cell lung cancer that has progressed or recurred after a 2-line system of chemotherapy.

Tianjing Bio and ABL Bio announce the completion of the first patient administration of TJ-L14B Phase 1 in the United States

Tianjing Bio and ABL Bio announce the completion of the first patient administration of TJ-L14B Phase 1 in the United States

On the 6th, Tianjing Bio and ABL Bio of South Korea jointly announced that the US Phase 1 clinical study of the bispecific antibody TJ-L14B/ABL503 jointly developed by the two parties has completed the first patient administration.

Eli Lilly Olumiant's application for treatment of moderate to severe atopic dermatitis is delayed by the U.

Eli Lilly Olumiant's application for treatment of moderate to severe atopic dermatitis is delayed by the U.

Renfu Pharmaceutical Memantine Hydrochloride Sustained-Release Capsules Received U.

Renfu Pharmaceutical Memantine Hydrochloride Sustained-Release Capsules Received U.

Bayer's Copanlisib lyophilized preparation for injection is planned to be included in the priority review program

Bayer's Copanlisib lyophilized preparation for injection is planned to be included in the priority review program

According to the official website of CDE, Bayer's Copanlisib injection freeze-dried preparation is planned to be included in the priority review procedure.
The product's marketing application was accepted by CDE on March 10, and it was the first PI3K inhibitor to be declared for marketing in China.
(Sina Pharmaceutical News)

Hengrui Medicine HR19042 capsule was approved for clinical use in the treatment of primary IgA nephropathy

Hengrui Medicine HR19042 capsule was approved for clinical use in the treatment of primary IgA nephropathy

Hengrui Pharmaceuticals issued an announcement stating that it has recently received the approval and issuance of the "Drug Clinical Trial Approval Notice" for HR19042 capsules from the State Food and Drug Administration, and clinical trials will be launched in the near future.
Indications: For the treatment of primary IgA nephropathy.
(Sina Pharmaceutical News)

Beida Pharmaceutical's Class 1 new anti-cancer drug BPI-421286 was approved for clinical use

Beida Pharmaceutical's Class 1 new anti-cancer drug BPI-421286 was approved for clinical use

Betta Pharmaceuticals issued an announcement stating that it has recently received the "Notice of Drug Clinical Trial Approval" (notice number: 2021LP00440, 2021LP00441) issued by the State Food and Drug Administration.
The company's BPI-421286 is used for the treatment of advanced solid tumors.
The trial application has been approved by the State Food and Drug Administration.
(Sina Pharmaceutical News)

Dongyang Sunshine GLP-1/FGF21 dual agonist HEC88473 injection was approved for clinical use

Dongyang Sunshine GLP-1/FGF21 dual agonist HEC88473 injection was approved for clinical use

According to the official website of CDE, the clinical trial application of the new drug HEC88473 injection developed by Dongyang Sunshine has been approved by the State Food and Drug Administration by default, and it plans to carry out clinical research on type 2 diabetes and weight loss.
HEC88473 is the first GLP-1/FGF21 dual agonist approved for clinical use in China.
(Sina Pharmaceutical News)

Livzon Triptorelin Pamoate Microspheres for Injection Received Clinical Approval

Livzon Triptorelin Pamoate Microspheres for Injection Received Clinical Approval

Livzon Group issued an announcement stating that the company and its wholly-owned subsidiary Zhuhai Livzon Microsphere Technology Co.
, Ltd.
have received the "Drug Clinical Trial Approval Notice" approved and issued by the State Food and Drug Administration, and the drug name is Pamoate Pamoate for Injection Prelin microspheres.
(a)

Junshi Biologics JS007 injection clinical trial application accepted

Junshi Biologics JS007 injection clinical trial application accepted

Junshi Biology issued an announcement stating that it had recently received the "Notice of Acceptance" approved and issued by the State Food and Drug Administration, and the clinical trial application for JS007 injection (project code "JS007") was accepted.
JS007 is a recombinant humanized anti-CTLA-4 monoclonal antibody injection independently developed by Junshi Biotechnology, which is mainly used for the treatment of advanced malignant tumors.
(Sina Pharmaceutical News)

Two injections of Renfu Medicine passed the consistency evaluation of generic drugs

Two injections of Renfu Medicine passed the consistency evaluation of generic drugs

Renfu Pharmaceutical issued an announcement stating that its subsidiary Yichang Renfu Pharmaceutical's nalbuphine hydrochloride injection and midazolam injection have been approved as supplementary applications.
(Sina Pharmaceutical News)

China Resources Shuanghe Finasteride Tablets (1mg) were approved for production

China Resources Shuanghe Finasteride Tablets (1mg) were approved for production

China Resources Double-Crane issued an announcement that the company's wholly-owned subsidiary, China Resources SECCO, received the "Drug Registration Certificate" (Certificate Number: 2021S00294) for Finasteride Tablets (1mg) issued by the State Food and Drug Administration on March 30, and approved the drug produce.
According to relevant national policies and regulations, it has been deemed to have passed the consistency evaluation.
(Sina Pharmaceutical News)

Variety of medical insurance negotiations! The first imitation of "Mirabellon Sustained-Release Tablets" is about to be approved

Variety of medical insurance negotiations! The first imitation of "Mirabellon Sustained-Release Tablets" is about to be approved

According to the official website of NMPA, Hangzhou Huadong Pharmaceutical Group Zhejiang Huayi Pharmaceutical Co.
, Ltd.
has changed its application status for the listing of the 4 generic drug "Milaberon sustained-release tablets" (acceptance number: CYHS1900699) to "under approval" and may be approved for listing in the near future .
After the drug is approved, it will become the first imitation in China.
(Insight database)

The latest results of the neutralization efficacy of the inactivated vaccine against the new coronavirus mutation are released

The latest results of the neutralization efficacy of the inactivated vaccine against the new coronavirus mutation are released

A joint research team from China published a paper in the "New England Journal of Medicine" describing the inactivated vaccine BBIBP-CorV developed by Sinopharm Group, or the inactivated vaccine developed by Beijing Kexing Zhongwei Biotechnology Co.
, Ltd.
in conjunction with multiple partners.
Volunteer serum of the inactivated vaccine Kellyford has the ability to neutralize the newly-emerged new coronavirus mutant strain.
(WuXi AppTec)