 Home > Active Ingredient News > Drugs Articles > More than 10 new drugs have been approved in China, from Eli Lilly, Roche, Merck, Hua Medicine, etc. October inventory

More than 10 new drugs have been approved in China, from Eli Lilly, Roche, Merck, Hua Medicine, etc. October inventory

 Last Update: 2022-11-04
 Source: Internet
 Author: User

Tags

human breast milk

new product development

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

According to the official website of China's National Medical Products Administration (NMPA) and press releases from various companies, at least 18 new drugs (excluding traditional Chinese medicines and vaccines) were approved for marketing or new indications
in China in October.
These drugs include glucokinase activators (GKA), RET inhibitors, anti-CCR4 antibodies, CAR-T products and other types, and are approved for indications covering tumors, diabetes, AIDS, autoimmune diseases, etc
.
This article will take you to see what are
the main new drugs approved in October.

These drugs include glucokinase activators (GKA), RET inhibitors, anti-CCR4 antibodies, CAR-T products and other types of glucokinase activators (GKA), and are approved for indications covering tumors, diabetes, AIDS, autoimmune diseases, etc

Hua Medicine Medicine: Dogliatin

Mechanism of action: glucokinase activator

Indications: Type 2 diabetes mellitus

On October 8, the NMPA announced that it had approved the marketing of Hua Medicine Class 1 new drug dogliatin tablets for improving blood sugar control
in adults with type 2 diabetes.
Public information shows that dopagliatin is a "first-in-class" GKA diabetes treatment drug
.
The approval of this drug not only marks the first approved product of Hua Medicine, but also marks the first approved GKA drug
in the world.
In two Phase 3 registration clinical studies, dopagliatin was able to rapidly act, continuously and effectively reduce glycated hemoglobin, significantly reduce blood glucose values two hours after meals in patients with type 2 diabetes, and continuously improve β cell function and insulin resistance
.

Dopagliatin is a "first-in-class" GKA diabetes treatment drug for improving glycemic control in adults with type 2 diabetes, marking the first approved GKA class drug worldwide

Eli Lilly/Innovent Biologics: Septinib

Mechanism of action: RET inhibitors

Indications: lung cancer and thyroid cancer

October 8, Eli Lilly and The Company announced that the highly selective transfection rearrangement (RET) inhibitor ceplitinib has been approved in China for patients with
RET-driven lung and thyroid cancers.
According to public information, cepitinib is a highly specific and powerful oral RET inhibitor developed by Eli Lilly, which is the first precision therapy
approved specifically for the treatment of cancer patients with RET gene mutations.
Innovent owns the exclusive commercialization rights
of cepitinib in China.
This time, the approval of cepitinib in China is based on the data of the global phase 1/2 clinical study LIBRETTO-001 and the Chinese population data
of the phase 2 clinical study LIBRETTO-321.
Sepretinib has been shown to have the advantage
of high response rate and long duration in patients with RET-driven non-small cell lung cancer, medullary thyroid cancer and thyroid cancer.

A highly specific, potent oral RET inhibitor for patients with RET-driven lung and thyroid cancer, the first precision therapy approved specifically for the treatment of patients with cancers bearing RET gene variants

Eli Lilly/Innovent Biologics: Ramotimumab

Mechanism of action: VEGFR-2 monoclonal antibody

Indications: advanced hepatocellular carcinoma

On October 8, Eli Lilly announced that its antiangiogenic drug ramoximab has been approved in China for the treatment of patients with hepatocellular carcinoma (HCC) who have previously received sorafenib
.
Ramotoximab is a fully human IgG1 monoclonal antibody developed by Eli Lilly, which has been approved in China for the second-line treatment of advanced gastric cancer, and Innovent has its exclusive commercialization rights
in China.
The drug binds specifically to vascular endothelial growth factor receptor 2 (VEGFR-2) and achieves an antitumor effect
by inhibiting the formation of blood vessels in tumor tissue 。 The approval of the new indication for ramoximab is based on the results of the global phase 3 study REACH-2 study, and the main cohort results show that the treatment group has a median overall survival (8.
5 months vs 7.
3 months), median progression-free survival (2.
8 versus 1.
6 months), objective response rate (4.
6 versus 1.
1 percent), disease control rate (59.
9 versus 59.
9 percent 38.
9%) and other indicators, which improved compared with the placebo group and were well
tolerated.

In patients with hepatocellular carcinoma (HCC), the drug can specifically bind to vascular endothelial growth factor receptor 2 (VEGFR-2), and achieve anti-tumor effect by inhibiting the formation of blood vessels in tumor tissue

Roche: Trastuzumab injection (subcutaneously)

Mechanism of action: Monoclonal antibody targeting HER2

Indications: Breast cancer

On October 9, Roche announced that trastuzumab injection (subcutaneous injection) was approved for marketing in China in combination with chemotherapy for the treatment of patients
with early-stage and metastatic HER2-positive breast cancer.
This is a subcutaneous injection type trastuzumab, which belongs to a ready-to-use preparation and can be administered
within 2~5 minutes.
According to a Roche press release, the product is a combination of
trastuzumab with a drug delivery technology called Enhanze.
Among them, trastuzumab is a monoclonal antibody targeting HER2 and is designed to block HER2 signaling; And from Halozyme Therapeutics' Enhanze technology is based on the company's proprietary recombinant human hyaluronidase PH20 (rHuPH20), an enzyme that temporarily degrades hyaluronic acid in the body, thereby aiding the dispersion and absorption
of other injectable therapeutic drugs.
A number of international clinical studies have shown that the efficacy and safety of trastuzumab subcutaneous preparations are comparable
to standard intravenous infusion of trastuzumab.

Combination chemotherapy for the treatment of patients with early and metastatic HER2-positive breast cancer can be dosed within 2~5 minutes

Cabot Norit Nederland/Hainan Zeshi Pharmaceutical: Pharmaceutical charcoal suspension granules

Mechanism of action: adsorbent antidote

Indications: acute intoxication or drug overdose

On October 9, the official website of the NMPA was announced, Cabot Norit The marketing application for Class 5.
1 new drug pharmaceutical charcoal suspension particles jointly declared by Nederland and Hainan Zeshi Pharmaceutical has been approved
.
According to the priority review announcement of the Center for Drug Evaluation (CDE) of the China National Food and Drug Administration, this is an antidote, which was approved for oral acute poisoning or drug overdose
.
According to literature reports, medicinal charcoal is a porous substance with a huge surface area, which can not only absorb unabsorbed poisons in the gastrointestinal tract, but also form a toxic concentration gradient between blood and gastrointestinal tract because of its full contact and adsorption with the digestive tract, thereby achieving the effect
of adsorption of blood poisons.

This is an antidote approved for acute oral poisoning or drug overdose
.

JW Therapeutics: relma-cel injection

Mechanism of action: CAR-T targeting CD19

Indications: follicular lymphoma

On October 10, JW Therapeutics announced that its CD19-targeting CAR-T cell immunotherapy product, relma-cel injection, has been approved for the second indication in China for the treatment of relapsed or refractory follicular lymphoma
.
According to public information, relma-cel injection is an autologous CAR-T cell immunotherapy product developed by JW Therapeutics on the basis of the autologous chimeric antigen receptor T (CAR-T) cell process platform of Juno Medical, a subsidiary of Bristol-Myers Squibb (BMS), which has previously been approved in China for the treatment of relapsed or refractory large B-cell lymphoma
.
The approval of the new indication for relma-cel injection is based on the results of
a key clinical study called RELIANCE, cohort B.
The data show that the product has a good and sustained disease remission rate and safety, of which the best complete response rate and objective response rate in 3 months reach 92.
6% and 100%,
respectively.

Approved for the treatment of relapsed or refractory follicular lymphoma with a 3-month optimal complete response rate and an objective response rate of 92.
6% and 100%, respectively

Merck: pembrolizumab injection

Mechanism of action: anti-PD-1 monoclonal antibody

Indications: hepatocellular carcinoma

On October 10, Merck (MSD) announced that its PD-1 inhibitor pembrolizumab (Keytruda) has been approved for the ninth indication in China, as a monotherapy for the treatment
of patients with hepatocellular carcinoma (HCC) who have previously received sorafenib or oxaliplatin-containing chemotherapy.
ACCORDING TO MERK'S PRESS RELEASE, THE NEW INDICATION APPROVED IN CHINA IS BASED ON THE DATA OF THE
PHASE 3 KEYNOTE-394 CLINICAL STUDY.
The trial results showed that pembrolizumab plus optimal supportive care reduced the risk of death by 21% and increased median overall survival (OS) (14.
6 months) compared with placebo plus best supportive care vs 13.
0 months).

PD-1 inhibitor pembrolizumab (Keytruda) monotherapy for the treatment of phase 3 KEYNOTE-394 clinical study in patients with hepatocellular carcinoma (HCC) who had previously received sorafenib or oxaliplatin-containing chemotherapy reduced the risk of death by 21% and median overall survival (OS) was extended (14.
6 months).
vs 13.
0 months)

Concord unicorn: mowglizumab injection

Mode of action: anti-CCR4 antibody

Indications: cutaneous T-cell lymphoma

On October 14, the official website of the NMPA announced that Concord Kyowa Kirin) antibody mowglizumab injection targeting CCR4 was approved for marketing
.
According to the priority review publicity information, the drug was approved for the treatment of adult patients with mycosis fungoides (MF) or Sézary syndrome (Sezari syndrome, SS), which are two common types of cutaneous T-cell lymphoma
.
According to the public information of Concord Kyunlin, the company reduces the fucose component in the sugar chain structure of mowglizumab through its original technology, which is expected to enhance antibody-dependent cytotoxicity and treat
malignant blood diseases.
Results from a phase 3 clinical trial called MAVORIC showed significantly longer progression-free survival (PFS) in MF patients treated with mowglizumab, with an average PFS of 7.
6 months (vs 3.
1 months) and the overall response rate increased to 28% (vs 5%)
.

In adults with mycosis fungoides (MF) or Sézary syndrome (Sezari's syndrome, SS), which are two common classes of cutaneous T-cell lymphomas, progression-free survival (PFS) is significantly prolonged, with an average PFS of 7.
6 months (vs 3.
1 months) and an overall response rate of 28% (vs 5%)

Haisco: Cyclopofol injection

Mechanism of action: GABAA receptor agonist

Indications: Sedation and anesthesia for gynecological outpatient surgery

On October 14, The official website of the NMPA announced that Haisco's innovative drug cyclopofol injection has been approved for new indications
.
According to Haisco's previous press release, the product was approved for sedation and anesthesia
for gynecological outpatient surgery.
Cyclopofol injection is a new intravenous anesthesia drug developed by Haisco, and its active ingredient cyclopofol is a small molecule drug with (R)-configuration isomers, which is a GABAA receptor agonist that can inhibit the central nervous system and produce anesthesia
.
Previously, the drug has been approved in China for multiple indications
such as sedation in digestive tract endoscopy, induction of general anesthesia, sedation in bronchoscopy, induction and maintenance of general anesthesia, and sedation during intensive care.

Sedation and anesthesia of gynecological outpatient surgery of cyclopofol injection Its active ingredient cyclopofol is a small molecule drug with (R)-configuration isoform, which is a GABAA receptor agonist

GlaxoSmithKline: Dolutegravirpivirin tablets mechanism of action: Dual-agent HIV therapy indication: AIDS

On October 21, the NMPA official website announced that the marketing application of dolutegraviripivine tablets declared by GlaxoSmithKline (GSK) has been approved for marketing
.
According to the CDE priority review announcement, the drug was approved for the treatment of adult HIV-1 infection patients
.
Dolutegravirpivirin is ViiV Healthcare (in which GSK has a majority stake) offers a two-drug HIV therapy that effectively suppresses HIV
.
Among them, dolutegravir is an HIV-1 integrase chain transfer inhibitor and ripivirin is a very small oral non-nucleoside reverse transcriptase inhibitor
.
Studies have shown that the dolutegravirpivirin regimen achieves non-inferior viral suppression at 48 weeks compared with a three- or four-agent regimen, with similar
rates of inhibition between treatment groups.

Dolutegravir is an HIV-1 integrase chain transfer inhibitor in adults with HIV-1 infection, and rilpivirin is a very small oral non-nucleoside reverse transcriptase inhibitor

Pfizer: Tofacitinib

Mechanism of action: JAK inhibitors

Indications: active psoriatic arthritis

On October 26, Pfizer announced that its two dosage forms, tofacitinib citrate tablets and tofacitinib citrate sustained-release tablets, have been approved in China for new indications in China for one or more adult patients
with active psoriatic arthritis (PsA) who do not respond well to antirheumatic drugs or do not tolerate them.
Tofacitinib is a JAK inhibitor that has been approved in China for the treatment of rheumatoid arthritis, ankylosing spondylitis and other indications
.
According to a Pfizer press release, the approval of the new indication is based on two global pivotal Phase 3 clinical studies and the results of a long-term extended study
.
The data showed that tofacitinib had similar efficacy to anti-tumor necrosis factor (TNFi) and met the primary efficacy endpoint
in people with poor TNFi response or intolerance.

Extended-release tablets are used in one or more adults with active psoriatic arthritis (PsA) who have poor response to or intolerance to antirheumatic drugs that improve their condition

Novartis: Treasury chilumab

Mode of action: anti-IL-17A monoclonal antibody

Indications: plaque psoriasis

On October 29, Novartis China announced that two new specifications of the innovative biologics skuchilumab, 300mg Carefree Pen and 75mg prefilled injection needle, have been approved by the NMPA, and its indications for psoriasis in children are extended to patients aged 6 years and above with moderate to severe plaque psoriasis who meet the indications for systemic therapy or phototherapy, and are no longer restricted
due to weight 。 Secucimumab is an interleukin-17A (IL-17A) inhibitor developed by Novartis, which can specifically neutralize IL-17A from multiple sources, inhibit its pro-inflammatory effect, and bring a new treatment option
to patients with moderate to severe plaque psoriasis.

Its indication for psoriasis in children is extended to patients 6 years of age and older with moderate to severe plaque psoriasis who meet indications for systemic therapy or phototherapy, and are no longer restricted by weight

Henlius: serplulimab

Mechanism of action: anti-PD-1 monoclonal antibody

Indications: Squamous non-small cell lung cancer

On October 31, the NMPA official website announced that the new indication marketing application of Henlius anti-PD-1 monoclonal antibody serplulimab injection has been approved
.
According to Henlius' earlier press release, this is the second indication approved for the product in China, specifically: combination chemotherapy first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer (NSCLC).

The marketing application for this new indication is mainly based on the results of an international multicenter phase 3 clinical trial, which shows that serplulimab combined with chemotherapy can significantly prolong PFS in patients, and has a higher objective response rate (ORR) and longer duration of response (DoR) than the control group, and has a good
safety profile.
Previously, serplulimab was also approved in China for the treatment of advanced adult solid tumors
with highly unstable microsatellite (MSI-H).

Combination chemotherapy for first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) serplulimab combined with chemotherapy significantly prolonged PFS in patients with higher objective response rates (ORR) and longer duration of response (DoR) than controls

In addition to the above new drugs, other improved new drugs were approved in October, such as levofolinic acid, lansoprazole sodium bicarbonate capsules, essomeprazole magnesium sodium bicarbonate capsules, tobramycin inhalation solution, etc
.
Due to space constraints, I will not introduce
them all here.
It is hoped that these products will be approved for marketing in China or obtain new indications, which can bring new treatment options and clinical benefits
to more patients.

Resources

[1] Hua Medicine Pharmaceutical's world's first innovative drug glucokinase activator Huatang Ning ® was approved for marketing! It is expected to expand the new pattern of type 2 diabetes treatment in China.
Retrieved Oct 9，2022，from https://mp.
weixin.
qq.
com/s/t3xfCn1OCTpQyIvB4DNqJA

[2] Lilly's highly selective RET inhibitor ceplitinib was approved in China to benefit patients with RET-driven lung and thyroid cancer.
Retrieved Oct 8, 2022.
From https://mp.
weixin.
qq.
com/s/xD5mz96v6KxerXJ6WNjeng

[3] Lilly antiangiogenic drug Ranxue ® (ramoximab) approved in China for advanced hepatocellular carcinoma.
Retrieved Oct 8，2020，from https://mp.
weixin.
qq.
com/s/gWk84RgAlSrtTvhxuumnpQ

[4] Thanoda ® (relma-cel injection) is approved by the NMPA for the treatment of relapsed or refractory follicular lymphoma.
Retrieved Oct 10，2020，from https://mp.
weixin.
qq.
com/s/NjALmUtCgNZ7-gw3czVpSw

[5] Merck PD-1 inhibitor KEYTRUDA ® has been approved in China for the treatment of liver cancer for patients with hepatocellular carcinoma (HCC) who have previously received sorafenib or oxaliplatin-containing chemotherapy.
Retrieved Oct 10, 2022, from https://mp.
weixin.
qq.
com/s/7s647VjHf4OnnmHdG5vxrw

[6] Herceptin ® subcutaneous preparation approved in China! Improving the treatment experience of breast cancer patients in China.
Retrieved Oct 9，2022, From https://mp.
weixin.
qq.
com/s/pAop93htF17VMLEi2TgUlQ

[7] Kyowa Hakko Kirin : Announces Positive Results of the Phase 3 Clinical Study of Mogamulizumab (KW-0761) in Patients with Cutaneous T-cell Lymphoma.
Retrieved April 7, 2017, from

[7] Kyowa Hakko Kirin : Announces Positive Results of the Phase 3 Clinical Study of Mogamulizumab (KW-0761) in Patients with Cutaneous T-cell Lymphoma.
Retrieved April 7, 2017, from [8] The application for registration of the new indication of the innovative drug cyclopofol injection was accepted.
Retrieved Feb 15, 2022, from

[8] The application for registration of the new indication of the innovative drug cyclopofol injection was accepted.
Retrieved Feb 15, 2022, from [9] Pfizer's innovative oral drug JAK inhibitor Shang Jie ® (tofacitinib citrate tablets) was approved for new indications.
Retrieved Oct 26 , 2022.
from https://mp.
weixin.
qq.
com/s/DoDHEHPIFqfT8GpvLuzGXA

[9] Pfizer's innovative oral drug JAK inhibitor Shang Jie ® (tofacitinib citrate tablets) was approved for new indications.
Retrieved Oct 26 , 2022.
from https://mp.
weixin.
qq.
com/s/DoDHEHPIFqfT8GpvLuzGXA

[10] Voluntary Notice - The marketing registration application (NDA) of serplulimab injection (recombinant anti-PD-1 humanized monoclonal antibody injection) combined with chemotherapy for the first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer has been accepted by the National Medical Products Administration.
Retrieved Sep 16，2021, from https://pdf.
dfcfw.
com/pdf/H2_AN202109161516598961_1.
pdf?1631813912000.
pdf

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.