CPhI Pharma Online (6.7-6.11)

This week, the pharmaceutical industry is quite lively.
The first domestic ADC drug and the first domestic liver cancer first-line targeted drug have been approved for marketing.
At the same time, the 2021 version of the medical insurance catalogue solicitation draft was released
.

Review

NMPA

Listed

1, June 7, Hutchison Whampoa cable where imatinib new indications listing application (admissibility: CXHS2000028) Entry "approval" stage, is expected to be in the recently approved
.

2.
On June 8th, BeiGene announced that CDE had accepted its anti-PD-1 tislelizumab injection (trade name: Beizean) for the treatment of previously treated, locally advanced unresectable or metastatic disease New indications for patients with high degree of microsatellite instability (MSI-H) or defective mismatch repair (dMMR) solid tumors
.

3.
On June 8, BeiGene's self-developed BTK small molecule inhibitor Zebutinib for adult Waldenstrom's macroglobulinemia (WM) market application (acceptance number: CXHS2000037) entered the "under review" stage, or Will be approved for listing in the near future
.

4, June 9, Jing Ze pharmaceutical class of drugs tosylate Dona pirfenidone sheet has been approved for marketing (admissibility: CXHS2000010), previously not received for unresectable hepatocellular carcinoma in patients with systemic therapy
.

       5.
On June 9th, Rongchang Biologics independently developed a new ADC drug for injection, vedixituzumab (code: RC48, trade name: Aidixi), which was officially approved for marketing with conditions .
This drug is an ADC drug independently developed by China.
It is suitable for the treatment of patients with locally advanced or metastatic gastric cancer (including gastroesophageal junction adenocarcinoma) who have received at least two types of systemic chemotherapy
.

       6, June 10, NMPA official website revealed that Henry injection Ka Ruili natalizumab new indications (Classified: 2.
2) was approved prospective
.

       7.
On June 10, the official website of NMPA showed that the Azilsartan tablets (acceptance number: CYHS1700170/1) declared by Hengrui Medicine according to registration classification 3 have been approved for the market for the treatment of hypertension
.

       8.
On June 10, Luye Pharma announced that its independent research and development of the first class of new drug Ansufaxine Hydrochloride Sustained-Release Tablets (LY03005) has been officially accepted for marketing
.

       clinical

       9.
On June 7, CDE's official website showed that the Degu aspartic insulin injection developed by Sihuan Pharmaceutical was approved for clinical use.
It is the first clinically approved biosimilar drug in China.
Only the original research Novo Nordisk has been approved.
Listed
.

       10.
On June 7, the clinical application for tissue factor (TF) -targeted antibody conjugate drug MRG004A submitted by Lepu Biotechnology was accepted
.
The IND application of MRG004A in the United States has been approved by the FDA, and a phase I study for TF-positive advanced or metastatic solid tumors is being carried out.
It is now the first domestic TF ADC drug to be declared for clinical use
.

       11.
On June 9, CDE's official website showed that the PD-1 monoclonal antibody Balstilimab (Balstilimab) cooperating with Betta Pharmaceuticals and Agenus was approved for clinical use in advanced cervical cancer
.
Bartilimumab is one of the two monoclonal antibody products acquired by Betta Pharmaceuticals from Agenus with a down payment of US$15 million and a share of US$20 million
.

       FDA

       12.
On June 4, Novo Nordisk announced that the FDA has approved simeglutide for new indications for long-term weight management
.
Specific indications are: adult obesity (initial BMI≥30kg/m2) or overweight (initial BMI≥27kg/m2) with at least one weight-related comorbidity for long-term weight management combined with diet and exercise
.

       13.
On June 7, the FDA issued an announcement conditionally approving the anti-Aβ monoclonal antibody Aducanumab for Alzheimer's disease
.
As the first of its kind, Aducanumab has always attracted attention, and the process of its research and development application is also very tortuous.
It has experienced many setbacks, such as clinical failure, questioning by regulatory agencies, and denial of experts.
The final conditional approval is not easy
.
However, the approval of the drug has injected a cardiotonic injection into the development of Aβ monoclonal antibodies, which has brought positive signals for subsequent Aβ monoclonal antibodies under development
.

       14.
On June 8, Pfizer announced that the U.
S.
FDA has approved PREVNAR20 (20-valent pneumococcal conjugate vaccine) to be vaccinated for adults aged 18 and over to prevent invasiveness caused by 20 serotypes of Streptococcus pneumoniae (pneumococcus) Disease and pneumonia
.

R&D

       15.
On June 9, Karyopharm Therapeutics, a partner of Deqi Pharmaceuticals, announced at the 2021 American Society of Clinical Oncology (ASCO) annual meeting that Eltanexor treats demethylation drugs (HMA) refractory myelodysplastic syndrome (MDS).
) Latest clinical data
.
Eltanexor is a new generation of oral XPO1 inhibitors
.

       16.
On June 11, Longyu Pharmaceutical announced that its new class I drug for the treatment of moderate to severe asthma, Cavosonstat (N91115), was officially launched in China and the United States
.
Cavosonstat is the world's first GSNOR inhibitor to enter clinical phase II.
It can non-competitively inhibit the catalytic decomposition of GSNO by GSNOR, thereby regulating many inflammatory pathways and cytokines such as STAT3 and NF-kB, and reducing the inflammatory response of asthma patients
.

       17.
On June 11, BM announced that its CD19-targeted CAR-T cell therapy Breyanzi reached the primary endpoint and key secondary endpoints in the phase 3 clinical trial.
Compared with standard treatment, it significantly improved relapse/refractory treatment.
Event-free survival, complete remission rate and progression-free survival of patients with B-cell lymphoma (LBCL)
.

policy

       18.
On June 9, the Medical Insurance Bureau just held a press conference on the "Clinical Efficacy and Safety of Drugs Selected in Centralized Acquisition of Real-World Research Project Results"
.
On the same night, the "Work Plan for the Adjustment of the National Medical Insurance Drug List in 2021" and the "Guidelines for the Application of the National Medical Insurance Drug List in 2021" were released for public comments
.

transaction

       19.
On June 9, BeiGene and Shoreline Biosciences announced that they have reached an exclusive global strategic cooperation, linking Shoreline's iPSCNK cell technology with BeiGene's preclinical R&D and clinical development capabilities to develop and commercialize a series of NK cell-based therapies The product portfolio is used to treat all kinds of malignant tumors
.

other

       20.
On June 7, according to CCTV News Weibo, the relevant person in charge of the scientific research team of the State Council’s Joint Prevention and Control Mechanism said in an exclusive interview with a reporter from the Central Station that the state has approved the expansion of the emergency use age range of the new crown vaccine to over 3 years old.
According to the needs of epidemic prevention and control, vaccination will be promoted from the high-age group to the low-age group
.
Previously, China's new crown vaccine users have covered people over 18 years old, and the oldest vaccinators are over 100 years old
.