 Home > Active Ingredient News > Drugs Articles > 20 blockbuster new drugs to be approved in 2023

20 blockbuster new drugs to be approved in 2023

 Last Update: 2023-02-01
 Source: Internet
 Author: User

Tags

hiv treatment cost

compound pharmaceuticals

Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com

In 2022, under the repeated new crown epidemic, the number of approved new drugs decreased slightly
, whether at home or abroad.
Good for the 2023 year, NMPA and FDA A promising new chapter
has been opened with the regulatory approval of the first new drug, respectively.
The NMPA approved the AIDS drug inomite, and the FDA started with the Aβ antibody Lecanemab
.

Trends and comparisons of domestic and foreign new drug approvals in the past 8 years

*Only "new drugs" are counted here, excluding "improved new drugs" and "similar drugs" Source: Insight Database Web Version (http://db.
dxy.
cn/v5/home/)

How many new drugs will the NMPA approve in 2023? Insight combines the current NDA projects and average review duration to look ahead to potential innovative drugs
for approval during the year.

In this year, we are expected to see the successive outbreak of more than 3 new drugs in popular targets, such as EGFR-T790M、PD-L1、ALK； The review progress of the star ADC drug Enhertu continues to advance in China; Cell therapy in BCMA targets ushered in the first domestic regulatory approval; There are corresponding breakthroughs
in hypoglycemia, lipid reduction, hair loss, migraine, etc.
that are hot in the non-tumor field.

Hot targets More than 3 new drugs continue to break out, star ADC drug Enhertu cell therapy in BCMA targets hypoglycemia, lipid reduction, hair loss, and migraine

This article will select 20 of them to share with readers, in no particular order
.
*The article is limited in space, can not introduce all new drugs, welcome to nominate in the comment area, we will show the review selection ~

Compiled by Insight

Three generations of EGFR-TKIs: befortinib, rezetinib, limetinib, orelitinib

After the first echelon three generations of EGFR-TKIs osimertinib, ametinib and vometinib, 4 of the second echelon in the country were in 2021 The annual reports are listed one after another, and now it is the time
to harvest.
The earliest 2 applications are from Betta Pharmaceutical and CSPC Pharmaceutical Group, which are expected to be approved
in 2023Q1.

Betta Pharmaceuticals · Befortinib

Befortinib mesylate is a third-generation EGFR-TKI developed by Betta Pharmaceuticals for the T790M mutation, and in March 2021, Betta Pharmaceuticals submitted a marketing application in China for treatment for previous use Locally advanced or metastatic non-small cell lung cancer
with T790M mutation following EGFR-TKI resistance.

Currently, according to the Insight database, the first-line indications for befacitinib have been published II/III in the 2022ESMO Phase clinical study results
.
Indications for adjuvant therapy are also gaining momentum, with IND applications
submitted on 15 November 2022.

and for patients with locally advanced or metastatic non-small cell lung cancer with T790M mutation after a generation of EGFR-TKI resistance, II Phase II clinical trial results showed an objective response rate (ORR) of 64.
8% and a disease control rate (DCR) of 64.
8% as assessed by an independent review committee (IRC).
95.
2%
。 The objective intracranial response rate (iORR) and the intracranial disease control rate (iDCR) was 97.
1%
in 34 subjects with brain metastases with baseline intracranial target lesions.

The results show that

Results of clinical trials of befacitinib

From: Insight Database Web

CSPC Pharmaceutical Group/Bystar Pharmaceuticals · Rezetinib

CSPC Pharmaceutical Group/By-Pharma · · Rezetinib

Rezetinib mesylate (BPI-7711) is an irreversible, highly selective third-generation small molecule EGFR-TKI that is sensitive to EGFR mutations and EGFR T790M Drug-resistant mutations have significant inhibitory activity
.
BPI-7711 has been shown to be deficient in EGFR (T790M/L858R, exon 19) in in vitro cell experiments Non-small cell lung cancer with gene mutation showed obvious antitumor activity, and the effective inhibitory concentration (EC50) was more than 35 times lower than that of EGFR gene wild type, reflecting a better safety profile
.

In March 2021, CSPC entered into a product authorization and commercialization agreement with Baseliner Pharmaceuticals and obtained BPI-7711 Commercialization licenses
in the People's Republic of China (including Hong Kong SAR and Macau SAR, but excluding Taiwan).
In May 2021, Bystar Pharmaceuticals filed with NMPA A new drug application
was submitted.

Data from the Phase IIb clinical trial of rezetinib were presented at the ASCO 2022 Congress
.
The results show that the ORR for BICR evaluation is 64.
6% (95% CI, 58.
0-70.
8), DCR was 89.
8% (95% CI, 85.
1-93.
4), and the ORR of patients with brain metastases (N=91) was 69.
0%（95%CI，49.
2-84.
7）
。 In addition, phase II clinical results of rezetinib as a first-line therapy have also been announced, as shown in the figure below
.

Results of clinical trials of rezetinib

From: Insight Database Web

BCMA-targeted CAR-T therapy: The first domestic BCMA-targeted therapy may be born in 2023 CAR-T

In June 2022, Innovent Biologics and Reindeer Medical's Iquilencel injection was declared for marketing and was included in the priority review and approval, resulting in the first domestic BCMA target CAR-T therapy was born, which is expected to be approved for marketing
in 2023.

The first domestic BCMA target to be declared for marketing CAR-T therapy was born, which is expected to be approved for marketing
in 2023.

Iquilencel injection (IBI326/CT103A) is a second-generation fully human BCMA-targeting CAR-T jointly developed by Innovent Biologics and Reindeer Medical Pharmaceuticals Therapy
.
This candidate transfects autologous T cells with lentivirus as a gene vector, and CAR contains fully human scFv, CD8a hinge and transmembrane, 4-1BB co-stimulation, and CD3ζ-activating domains
.

In December 2021, Innovent Biologics and Reindeer Medical presented the latest 1/2 of Iquilensa in an oral presentation at the 2021 ASH Annual Meeting Phase registration clinical study results
.
This is a single-arm, open-label, multicenter clinical study conducted in China that enrolled prior ≥ 3rd line therapy, positive plasma cell membrane expression of BCMA, and ECOG Patients with relapsed/refractory multiple myeloma (R/R MM) scored 0 to 1 with the primary endpoint of overall response rate (ORR).

1/2 Phase Enrollment Clinical Results Results in Patients with Relapsed/Refractory Multiple Myeloma (R/R MM) with the primary endpoint of overall response rate (ORR)

The results show that IBI326 has excellent and long-lasting effectiveness with an ORR of 94.
9%, complete response/strict complete response (CR/sCR) was 58.
2%, and the response tended
to deepen with the extension of follow-up.
PFS at 6, 9, and 12 months after infusion were 78.
0%, 76.
0%, and respectively 71.
0%
。 There was still a good response to participants who relapsed after previous CAR-T treatment, with 13 previously accepted patients enrolled in the trial Participants treated with CAR-T had an ORR of 76.
9%, 61.
5% achieving a very good partial response (VGPR) and above, and a CR/sCR of 46.
2%.

The results show that IBI326 has excellent and long-lasting effectiveness with an ORR of 94.
9% of complete responses/strict complete responses (CR/sCR) were 58.
2% had good efficacy for participants who relapsed after previous CAR-T treatment, and the 13 previously accepted patients enrolled in the trial The ORR of CAR-T-treated participants was 76.
9%

The safety profile is also excellent and controllable, most patients have grade 1~2 cytokine release syndrome (CRS), and only 2 subjects in IIT stage have grade 3 or more CRS, and no grade 4/5 CRS
。 All participants had remission of CRS and ICANS, with 20% treated with tocilizumab and 34.
7% with glucocorticoids
.

This study is the first registered clinical trial in the world to enroll subjects who have failed prior CAR-T therapy and is expected to address this subset of untreatable treatment needs
.

Iquilencel clinical trial results

From: Insight Database Web

ALK inhibitors: Qilu Pharmaceutical vs Chia Tai Tianqing

For ALK inhibitors, 2023 may usher in the approval
of 3 products.
Including Qilu Pharmaceutical, Iruak, as well as Chia Tai Tianqing, Yifeng Ak, and TQ-B3101
.

Iruak and Chia Tai Tianqing rely on Ake and TQ-B3101
.
Ibi Akko and TQ-B3101
.
TQ-B3101
。

Qilu Pharmaceutical · Iruak

Qilu Pharmaceutical · Iruak · Iruak

Iruac is a new ALK/ROS1 independently developed by Qilu Pharmaceutical Inhibitors
.
The indications currently declared for marketing are: locally advanced or metastatic non-small cell lung cancer (NSCLC) with anaplastic lymphoma kinase (ALK)
-positive disease progression or intolerance to crizotinib after prior crizotinib treatment.
This is also the first product of Qilu Pharmaceutical to be listed on the market Class 1 new drugs, a milestone
.

Iruak's Phase I data was previously published in the journal Signal Transduction and Targeted Therapy
.
Since September 2017 From 25 to October 15, 2018, a total of 54 patients with ALK/ROS1+ NSCLC were enrolled in the ascending phase and 99 patients with ALK/ROS1+ in the extended phase NSCLC patients, a total of 153 patients were treated
with Iruac tablets.

The results showed that Iruac has good safety, tolerability, and antitumor activity
in patients with ALK/ROS1+ NSCLC.
Specifically: the overall ORR was 59.
3%, respectively (32/54) and 56.
6% (56/99).

Among ALK-positive NSCLC patients who were not treated with ALK inhibitors, the two-stage ORR was 81.
0%, respectively (17/21) and 76.
3% (29/38); In patients with ALK+NSCLC who had previously received crizotinib, the two-stage ORR was 38.
1% (8/21) and respectively 45.
7% (21/46)； In patients with ROS1+ NSCLC, the two-stage ORR was 30.
0% (3/10) and 44.
4% (4/9),
respectively.

Iruac clinical trial results

From: Insight Database Web

Chia Tai Sunny · TQ-B3101, Ibong Acre

Chia Tai Sunny · TQ-B3101、Yifeng Akchia Tai Tianqing · TQ-B3101, Ike TQ-B3101, Ak-Ak

The TQ-B3101 and Yifeng Aker (TQ-B3139) laid out by Chia Tai Tianqing are both ALK/MET/ROS1 inhibitors, and are advancing the marketing review process for ROS1-positive and ALK-positive NSCLC, respectively, and are expected to be in Q4 2023 Approved
.

TQ-B3101 and Eva Ak (TQ-B3139) are both ALK/MET/ROS1 inhibitors.

Previously, CT Tianqing disclosed TQ-B3101 for the first-line treatment of ROS1-positive NSCLC II Phase clinical data (registry number: NCT03972189) showed that the ORR assessed by the Independent Review Committee (IRC) was 78.
4% (95% CI, 69.
6-85.
6) and the mPFS was 15.
6 months (95% CI, 10.
2-27.
0).

TQ-B3101 test results

From: Insight Database Web

TQ-B3139 It is jointly developed by CP Tianqing and First Drug Holdings, with First Drug Holdings responsible for the design and optimization of compound molecules, and the verified preclinical candidate compounds transferred to Tianqing for clinical stage development, and both parties jointly enjoy intellectual property rights
.

At the 2022 ESMO meeting, the phase III clinical TQ-B3139-III-01 for the first-line treatment of ALK-positive advanced NSCLC with acbicrizotinib was disclosed Experimental data
.
The primary endpoint of the study was progression-free survival (PFS)
as assessed by an independent review committee (IRC).
Results showed that mPFS (IRC assessment) in the efengac group was significantly better than in the crizotinib group (NR vs 11.
89m； HR = 0.
46, p<0.
0001), and patients with TP53 mutations could also benefit from efonacre therapy (mPFS: 11.
93m vs 7.
85m，HR = 0.
47）
。 The ORR assessed by IRC was 81.
68% versus 69.
92%, with longer-lasting efficacy in the Aeke group (mDoR:NR vs 12.
68m，p= 0.
0014）
。 NCT04009317 Test results

From: Insight Database Web

PD-L1 monoclonal antibody: Kelun Pharmaceutical, Hengrui Pharmaceutical, Lee's Pharmaceutical

Domestically, although PD-L1 is not as competitive as PD-1, 2021 The year has gradually entered an explosive period
.
In a short period of time, the first-echelon of envolimab and sugemalimab have been approved successively, followed by Lee's Pharmaceutical's first gram injection of limab, Kelun Pharmaceutical's tetermumab and Hengrui adebelimab have been declared for marketing, and are expected to be in the market All three will be approved
in 2023.

Lee's Pharmaceuticals Shougram injected limab, Kelun Pharmaceutical's Tetermumab, Hengrui adebelimab

Lee's Pharmaceutical/WuXi Biologics · The first gram of limumab

Lee's Pharmaceutical/WuXi Biologics · Shougram Lilimab Lee's Pharmaceutical/WuXi Biologics · Shougram Lilimab Lee's Pharmaceutical/WuXi Biologics · Shougram Lilimab Lee's Pharmaceutical/WuXi Biologics · The first gram of limonomab limonomab

Socazolimab/ZKAB001 is a targeted PD-L1 introduced by Lee's Pharmaceutical Company from Sorrento Therapeutics Monoclonal antibodies
.
It was filed for marketing and accepted in October 2021 for relapsed/metastatic cervical cancer, and is expected to be approved
in the second half of this year.

Socazolimab is a fully human anti-PD-L1 screened using Sorrento's patented G-MAB™ library platform Monoclonal antibodies
.
Compared with competitors, it has the following potential advantages: as a fully human antibody, low immunogenicity; Compared to others PD-L1, the dose required for efficacy is small; It also has a dual mechanism
of immune checkpoint inhibition and antibody-dependent cytotoxicity (ADCC).

The clinical study of Socazolimab monotherapy for recurrent and metastatic cervical cancer was conducted in two phases, the first being open label 3+3, led by Director Wu Lingying The dose escalation phase is followed by the critical expansion phase study
.
A total of 91 patients participated in the pivotal study component, and the results showed Socazolimab Good efficacy, improved tumor response rate, independent of patient PD-L1 expression level; Response duration, progression-free survival, and overall survival were all prolonged
.

Socazolimab Good efficacy, improved tumor response rate, independent of patient PD-L1 expression level; Response duration, progression-free survival, and overall survival were all prolonged
.

Results of clinical trials of first gram injection of limonomab in the treatment of cervical cancer

From: Insight Database Web

Kelun Pharmaceuticals · Tetelimab

Tetelimab (A167) is the first innovative project of PATEO to enter the manufacturing stage, and the world's first PD-L1 monoclonal antibody
to submit NDA for the indication of nasopharyngeal carcinoma.
According to the Insight database According to the show, CDE accepted the listing application in November 2021 and is expected to be approved
in the second half of this year.

Colombertai in April 2018 Reached a global strategic cooperation with Harbour Pharmaceutical, relying on target, fully human monoclonal antibody and bispecific antibody platform technology to jointly research, develop and commercialize new fully human antibody drugs, and jointly bear clinical and commercialization costs, and share global rights and commercial profits
equally.
Today, nearly half of Cologne's antibody pipeline is a project with Hutplatin, A167 It was one of them that Harbour Platinum acquired overseas rights
to the drug for a potential excess of $350 million.

Titelimab pharmaceutical transactions

From: Insight Database Web

Hengrui Pharmaceutical · Adelibimab

Hengrui Pharmaceutical · Adelibilimab Hengrui Pharmaceutical · Adelibilimab Hengrui Pharmaceutical · Adelibilimab Hengrui Pharmaceutical · Adebelimab Adebelimab

In January 2022, Hengrui Pharmaceutical's PD-L1 monoclonal antibody "adebelimab" marketing application was accepted
.
This is the PD-L1 declared for marketing in paragraph 5 of domestic production Monoclonal antibodies
.

Previously in October 2021 In January, Hengrui Pharma announced that adebelimab (SHR-1316) combined with chemotherapy is a randomized, double-blind, placebo-controlled, multicenter treatment for extensive-stage small cell lung cancer The primary endpoint results of the Phase III clinical study met the efficacy criteria preset by the protocol
.
The results showed that SHR-1316 plus chemotherapy compared to placebo plus chemotherapy significantly prolonged patient survival (OS).

First-line treatment for extensive-stage small cell lung cancer

At the 2022 AACR conference, the detailed research results of CAPSTONE-1 were disclosed, as shown in the figure below:

CAPSTONE-1 STUDY RESULTS

From: Insight Database Web

Metabolic field: siRNA, bi-target hypoglycemic drugs

In the field of metabolism in 2023, long-acting RNAi lipid-lowering drugs and GLP-1R/GIPR dual agonists
will be ushered in.

Novartis · Long-acting RNAi lipid-lowering drugs

November 2022, Novartis Inclisiran The injection is declared for marketing in China (acceptance number: JXHS2200110) and is expected to be approved
in the second half of this year.
Inclisiran (R&D code: KJX839) is a Novartis 97 $100 million acquisition of a PCSK9-targeting long-acting RNAi acquired by TMC Lipid-lowering drugs, which only need to be administered subcutaneously twice a year to effectively reduce LDL-C in the blood circulation to achieve the effect
of lowering blood lipids.

Novartis with 97 $100 million acquisition of a PCSK9-targeting long-acting RNAi acquired by TMC Lipid-lowering drugs only need to be administered subcutaneously twice a year

Compared to the frequency of biweekly or monthly administration of PCSK9-targeted antibody drugs and statin lipid-lowering drugs currently on the market, Inclisiran Unique therapeutic advantage
in terms of patient adherence.

Previously, Novartis disclosed the ORION series of studies showing that LDL-C after lowering therapy using the maximum tolerated dose of LDL-C Patients
whose levels remain above target.
Patients treated with Inclisiran had an average reduction in LDL-C from baseline to day 510 compared with placebo 50%～52%
。

Inclisiran-treated patients have an average reduction in LDL-C from baseline to day 510 50%～52%

ORION-10, ORION-11 RESEARCH RESULTS

From: Insight Database Web

For patients with concomitant cerebrovascular disease (CeVD) and multivascular disease (PVD) ASCVD, Novartis announced in September 2021 Results from two pooled post-hoc analyses of the ORION-9, ORION-10, and ORION-11 research trials also suggest that treatment with Inclisiran twice a year is effective and sustainably reduced LDL-C levels
in the ASCVD subgroup of patients (CeVD, PVD).

Patients with concomitant cerebrovascular disease (CeVD) and polyvascular disease (PVD) ASCVD

At the 2022 AHA Annual Meeting, Novartis also announced the results of a 4-year Phase II open-label ORION-3 expansion trial: Inclisiran is available at 4 Sustained and effective reduction of LDL-C levels
in critically ill patients such as ASCVD or ASCVD during the year.
These patients were previously treated with maximally tolerated statin therapy with LDL-C Still elevated
.

Inclisiran is available at 4 Sustained and effective reduction of LDL-C levels in critically ill patients such as ASCVD or ASCVD during the year

In terms of safety, Inclisiran was well tolerated after 4 years of treatment, with safety profiles comparable to the previous 18-month Phase III study LDL-C Lower consistently
.
The most common adverse events following drug-related treatment were systemic disease and various reactions at the injection site, most of which were mild to moderate
.

Eli Lilly · GLP-1R/GIPR Double agonist

Eli Lilly · GLP-1R/GIPR Double agonists · · · GLP-1R/GIPR Dual agonist GLP-1R/GIPR Double agonist

Eli Lilly's GLP-1R/GIPR, September 2022 The double agonist "telpotide injection" was declared for marketing in China (acceptance number: JXHS2200075/6/7/8).

Tirzepatide injection is the first treatment for type 2 diabetes GLP-1R dual-target hypoglycemic agent, administered once a week, has defeated semeglutide head-to-head in large phase III clinical trials, causing heated discussions
.
May 2022 This month, the FDA just approved the drug for marketing
in the United States.
The SURPASS series of global phase 3 clinical development programs for telpotide was initiated in late 2018 and includes 5 global registration trials and 2 regional clinical trials
in Japan.
In 2021, Eli Lilly announced the results of these registrational clinical trials one after another, and won
head-to-head.
Among them, head-to-head smeglutide SURPASS-2 (Registration number: NCT03987919) was particularly impressive, comparing telpotide 5 mg (N=470), 10 mg (N=469) and 15 mg (N=469) Hypoglycemic effect
with semeglutide 1 mg (N = 468).
The results showed that telpotide reduced A1C by an average of 2.
0% and 2.
2% compared to the baseline A1C level (8.
3%) and 2.
3%, while semeglutide decreased by an average of 1.
9%; In terms of weight loss, telpotide reduced subjects an average of 17 lbs.
, 21 lbs.
, and 25 lbs compared to a baseline weight of 207 lbs.
, compared to semeglutide 13 lbs
.
The success of challenging semeglutide means that a new revolution is about to start, and dual-target agonist hypoglycemic drugs are about to become the main contenders
in the subsequent hypoglycemic field.
SURPASS-2 test results

Defeated semeglutide head-to-head in large phase III clinical trials

From: Insight Database Web

Migraine: CGRP targets 3 key players start the process of listing in China

For CGRP antagonists, there has not been any approved for marketing in China before, but since 2022, this class of drugs has begun to be intensively declared in China, from Novartis' Erenumab to Eli Lilly's Galcanezumab, and then to Pfizer's Rimegepant, all 3 products are expected to be approved
this year.

Novartis/Amgen · Irenezumab

In April 2022, Novartis and Amgen collaborated to develop a new migraine drug, erenemumab/Erenumab Filed and accepted in China (acceptance number: JXSS2200012), which is also the first anti-CGRPR monoclonal antibody
declared for marketing in China.

First developed by Amgen, Erenumab (AMG334) is a fully human IgG2 monoclonal antibody that treats migraine
by binding to and antagonizing CGRP receptor function 。 August 2015 In January, Novartis partnered with Amgen to develop new drugs in the field of Alzheimer's disease and migraine, including Erenumab; In April 2017, the two companies expanded their focus on Erenumab A global collaboration to jointly develop Erenumab in the United States, Amgen retains exclusive commercialization rights in Japan, while Novartis commercializes the product in other parts of the
world.

Erenumab pharmaceutical deal

From: Insight Database Web

In March 2021, Novartis announced positive results from the DRAGON Phase III study to meet the primary endpoint
.
This is a randomized, double-blind, multicenter, placebo-controlled phase III clinical trial designed to evaluate Efficacy and safety
of Erenumab prophylactic treatment of chronic migraine in adults.
A total of 557 patients were enrolled in the study, mainly in Chinese groups centered in Asia
.

The results showed that the Erenumab 70 mg group was in the last 4 of the 12-week double-blind treatment period Weeks compared to baseline to reduce the number of migraine days (MMD) per month was significantly better than
placebo in the efficacy endpoint (primary endpoint).
In addition, the Erenumab 70 mg group had a 50% reduction in the number of migraine days per month compared to baseline The response rate above was significantly higher than that of the placebo group
.
At the same time, the safety tolerability profile of Erenumab was similar to that of the placebo group, and no new safety issues
were identified.

DRAGON test results

From: Insight Database Web

Pfizer · Rimegepant

Pfizer · Rimegepant Pfizer · Rimegepant Pfizer · Rimegepant Pfizer · RimegepantRimegepant

Pfizer partnered with Biohaven in November 2021 for a total of $1.
24 billion to acquire rights to two CGRP antagonists, including oral migraine medications Rimegepant (Nurtec® ODT) interests
outside the United States.

Rimegepant targets key components of migraine by reversibly blocking CGRP receptors, thereby inhibiting the biological cascade that leads to migraine attacks
.

It was first approved in the US in February 2020 and expanded in May 2021, making it the first oral CGRP approved for both acute and prophylactic treatment of migraine in adults Receptor antagonists
.
Since then, it has been approved for marketing
in Europe in April 2022.

In February 2022, Biohaven and Pfizer jointly announced Rimegepant for the treatment of acute migraine3 Phase II clinical trials met the common primary endpoints
of efficacy and safety.
This is the 4th positive 3 of Rimegepant for acute migraine treatment Phase II clinical study, which is also the first study
to be conducted in the Asia-Pacific region.

Treatment of acute migraine 3 Phase II clinical trials achieved the common primary endpoint of efficacy and safety, the first study conducted in the Asia-Pacific region

The study is a randomized, multicenter Phase 3 clinical study (registry number: NCT04574362) involving a total of 1431 adult patients, of which nearly 80% of the participants enrolled are from China and the remainder approximately 20% in South Korea
.

Results showed painless (p<0.
0001) and the most annoying migraine-related symptoms (MBS, including nausea, phobia, or photophobia) after 2 hours of single oral administration Common primary endpoint (p<0.
0001).

In this study, a single oral dose of rimegepant 75 mg significantly reduced migraine symptoms and significantly improved migraine symptoms.
2 Normal function is restored after hours and provides sustained response
for up to 48 hours in many patients.

In terms of safety, Rimegepant has shown good safety and tolerability in study participants, which is consistent with
the results of previous clinical trials in the United States.

NCT04574362 Clinical trial results

From: Insight Database Web

Eli Lilly · Galcanezumab

Eli Lilly · Galcanezumab · ·

July 2022, Eli Lilly CGRP monoclonal antibody Galcanezumab The marketing application of injection solution in China was accepted (acceptance number: JXSS2200028).

Galcanezumab (trade name: Emgality) was first approved by the FDA in September 2018 Approved for marketing for the prophylactic treatment of migraine
in adults.
Subsequently, in June 2019, the new indication was re-approved by the FDA Approved for the treatment of episodic cluster headache (ECH)
in adults.

Migraine in adults is used to treat episodic cluster headache (ECH) in adults

In September 2021, Eli Lilly China announced that Galcanezumab is used for the prophylactic treatment of global multicenter phase III CGAX for the prophylactic treatment of episodic migraine in adults The study yielded positive primary findings
.
CGAX studies were conducted at all previously completed Galcanezumab at the primary endpoint and all 4 key secondary endpoints Global findings are highly consistent
.

Galcanezumab is used for the prophylactic treatment of global multicenter stage III CGAX in adults with episodic migraine The study yielded positive primary findings
.

On the primary study endpoint, Days of Headache per Month (MHD), the CGAX study showed Galcanezumab The treatment group was significantly better than the placebo group
.
Of the four key secondary endpoints assessing the functional effects of migraine, MSQ score (quality of life score), 50% remission rate (50% improvement in headache days from baseline CGAX data also show superiority over placebo in the treatment group, consistent with
the primary findings completed globally, for 75% response rate and 100% response rate.

CGAX studies showed that Galcanezumab had a good safety profile, with mild to moderate severity of adverse events, no serious adverse events or deaths, and known safety results Galcanezumab has consistent
security characteristics worldwide.

Long-acting G-CSF white needle: Bergstim, Toppegrastim

Long-acting G-CSF Liter White Needle: Long-acting G-CSF Liter White Needle Long-acting G-CSF Rising White Needle Bergstim, Toppefilgrastim Bergstim

In 2023, two long-acting G-CSFs are expected to be approved in China, namely Pegstim, Chia Tai Tianqing/Yifan Pharmaceutical, and Topefilgrastim
of Tebao Biotechnology.

Chia Tai Tianqing/Yifan Pharmaceutical · Bergstine

Chia Tai Tianqing/Yifan Pharmaceutical · Bergstimchia Tianqing/Yifan Pharmaceutical · Chia Tai Tianqing/Yifan Pharmaceutical · Yifan Pharmaceutical

Chia Tai Tianqing/Yifan Pharmaceutical Begerstim (F-627) is a long-acting one G-CSF, currently in the marketing application stage, is used to prevent and treat neutropenia caused by chemotherapy in cancer patients, and is expected to be approved
in China this year.

It will be approved
domestically this year.

In August 2021, Yiyi Biotech has reached a cooperation with Chia Tai Tianqing on F-627, with a down payment of 30 million yuan + up to 180 million yuan milestone + The tiered net sales royalty exclusively licenses all intellectual property and commercialization rights of F-627 in China to Tianqing Nanjing Shunxin for a total transaction of more than RMB210 million
.
Sunny Nanjing Shunxin received F-627 After the marketing authorization of the drug, Beijing Yiyi will be entrusted to carry out production
.

Bergstein is a third-generation recombinant long-acting G-CSF that forms dimers through Fc fusion proteins without PEG modification and better avoids PEG The immune response caused by it, so it has certain advantages
in safety compared with the current mainstream second-generation products in the market.

Bergstine

F-627 is currently the only G-CSF drug on the market that has undergone a large head-to-head study with both short- and long-acting G-CSF, and has completed clinical III in China and the United States and submitted listing applications
in China and the United States.

Results of clinical trials of bergstim in the treatment of chemotherapy-induced neutropenia

Tebao Bio · Toppegrastim

Tebao Bio · Toppe Filgrastim Terpo Biology · Tebao Bio · Tebao Bio Toppe Filgrastim Toppe Filgrastim

In April 2022, Tebao Biotoppefilgrastim injection (Y-type polyethylene glycol recombinant human granulocyte stimulating factor) was declared for marketing and is expected to be approved
this year.

Tebao Bio's Toppefilgrastim is a Y-type polyethylene glycol recombinant human granulocyte stimulating factor (YPEG-G-CSF) using 40kD Y The branched polyethylene glycol (PEG) molecule modifies
recombinant human granulocyte-stimulating factor (rhG-CSF).

Autoimmune disease riterxitinib

September 2022, Pfizer JAK3 The inhibitor "Ritlecitinib capsule" (R&D code: PF-06651600) was declared for marketing in China for 12 suitable for systemic treatment Adolescents and older and adults with alopecia areata, including alopecia omnifolia and alopecia universalis (acceptance number>> JXHS2200081), were included in the priority review
in November.

Risextitinib is also the only JAK inhibitor
in China that has been included in the breakthrough therapy program with the indication of alopecia areata.

Ritercitinib is an orally targeted JAK3 inhibitor developed by Pfizer that selectively inhibits
the JAK isoenzyme through covalent interaction with JAK3-specific residue CYS-909.
With the first generation pan Compared with JAK inhibitors, this drug has advantages
in reducing toxicity.

According to the Insight database, it was late August to 9 this year At the beginning of the month, Pfizer has submitted a new drug marketing application to the drug regulatory authorities in the four mainstream regions of China, the United States, Japan and Europe almost simultaneously, and it has been accepted, and alopecia areata is its first indication.

The FDA and EMA are expected to be in 2023 Review decisions
will be made in the second and fourth quarters of the year.
The new drug application for riterxitinib for this indication is based on a pivotal, dose range of 2b/3 ALLEGRO Clinical trial (registry number: NCT03732807), and results from the ongoing open-label Phase 3 ALLEGRO-LT clinical trial (registry number: NCT04006457).

The ALLEGRO study included a total of 718 patients with alopecia areata 12 years of age and older who had 50% or more scalp hair loss and symptoms of alopecia areata for at least half a year
.
Patients were randomly assigned to receive once a day Ritlecitinib 50 mg, 30 mg, 10 mg, or placebo
.

Results showed that in terms of efficacy, patients treated with 30 mg and 50 mg ritlecitinib (with or without initial treatment) compared to placebo were treated with or without treatment 6 After one month, scalp hair loss was significantly higher in ≤20% of patients than in the placebo group
.

In terms of safety, Ritlecitinib is well tolerated
in both adult and adolescent patients.
During week 48, 82% and 2%, respectively of patients experienced adverse events (AEs) and serious adverse events (SAEs).

The most common AEs are headache, nasopharyngitis, and upper respiratory tract infections
.

Results of Phase 2b/3 clinical studies

From: Insight Database Web

ALLEGRO-LT is an ongoing open-label, long-term Phase III clinical study to study Ritlecitinib Safety and efficacy
in adults with alopecia areata with a rate of 25% or more and in adolescents aged 12 years with alopecia areata in adolescents aged 12 years with a rate of alopecia areata.

ALLEGRO-LT

The long-acting complement C5 inhibitor corolinumab

Corolimab (Crovalimab/RO7112689) is Roche's next-generation complement C5 inhibitor for paroxysmal nocturnal hemoglobinuria (PNH) as of August 2022 It is worth mentioning that corolimab is Roche's first new drug starting in China and is expected to be approved
this year.
As long-acting complement C5 The inhibitor, Crovalimab, can be administered once a month, and as a subcutaneous injection, patients can self-administer it at home, greatly improving adherence
.
This drug targets C5 The epitope is different from the first comparable drug, eculizumab (Soliris), so it can cover patients
with C5 polymorphisms not covered by eculizumab.

Roche's first new drug originating in China is expected to be approved
this year.

Crovalimab clinical trial results

From: Insight Database Web

This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

In 2023, these 20 blockbuster new drugs are expected to be approved in China

12-30

20 blockbuster new drugs to be approved in 2023

Related Articles

In 2023, these 20 blockbuster new drugs are expected to be approved in China