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According to Insight database statistics, last week (October 24 - October 30), a total of 45 innovative drugs (including improved new) in the world have advanced to a new stage of research and development, of which 8 are declared for clinical trial for the first time and 14 are approved for clinical trial
for the first time.
approvals.
Below, Insight will extract some key projects at home and abroad for introduction
.
Progress of innovative drugs in China
Progress of innovative drugs in ChinaDomestically, a total of 31 innovative drugs (including improved new) research and development progress has advanced to a new stage this week, of which 8 have been declared for clinical trials and 9 have been approved for clinical trials
, 9 for
the first public clinical trial.
Last week, 9 innovative drugs (including improved new) that launched clinical trials for the first time in China
From: Insight Database Web (http://db.
dxy.
cn/v5/home/)
Filing for listing
Filing for listing1.
Innovent Biologics: PI3Kδ inhibitor was declared for marketing and is intended to be prioritized for review
Innovent Biologics: PI3Kδ inhibitor was declared for marketing and is intended to be prioritized for review
On October 25, CDE's official website showed Parsaclisib, the PI3Kδ inhibitor of Innovent Biologics
A marketing application has been submitted for inclusion in priority review for adult patients
with relapsed or refractory follicular lymphoma who have received at least two prior systemic therapies.
.
From: CDE website
Parsaclisib comes from Innoventa's partnership
with Incyte in 2018.
In this collaboration, Innovent Biologics won 3
The oncology drug has clinical development and commercialization rights in Chinese mainland, Hong Kong, Macau and Taiwan, while Incyte received an upfront payment of $40 million from Innovent and a second tranche after the initial IND application
$20 million in payments, up to $129 million in potential development and regulatory milestones and $202.
5 million
in potential commercial milestones.
The 3 drugs are: itacitinib (JAK1 inhibitor), pemigatinib (FGFR inhibitor), and parsaclisib (PI3Kδ
Inhibitors).
In China, pemigatinib has been approved for marketing in April this year, and now Parsaclisib has also submitted a marketing application, itacitinib
is in phase 1/2 clinical trials
.
Details of pharmaceutical transactions
Screenshot from: Insight database
Innovent released data from Parsaclisib in Chinese population at the 2022 ASCO conference: ORR reached in follicular lymphoma patients (N=61).
86.
9% (95% CI, 75.
8-94.
2), of which 31.
1% (95% CI, 19.
9-43.
3) achieved CR:
Parsaclisib Chinese @2022ASCO
Screenshot from: Insight database
Domestically, Parsaclisib is a PI3Kδ inhibitor
declared for marketing in paragraph 3.
In March this year, CSPC introduced PI3Kγ/δ
The inhibitor Duencib has been approved for follicular lymphoma; Limpris, a collaboration between Hengrui and Lingli, has been listed since May last year and is also expected to be approved
within the year.
Domestic clinical phase II and above PI3Kδ inhibitors
Screenshot from: Insight database
2.
Haisco: Class 1 analgesic new drug HSK16149 was declared for marketing
Haisco: Class 1 analgesic new drug HSK16149 was declared for marketing
On October 27, according to the official website of CDE, Haisco Class 1 analgesic new drug HSK16149
Application for listing (acceptance number: CXHS2200058).
According to the progress of clinical research, it is speculated that the approved indication should be diabetic peripheral neuropathy
.
From: CDE website
HSK16149 capsule is a Class 1 new drug
developed by Haisco with independent intellectual property rights for the treatment of diabetic peripheral neuralgia, postherpetic neuralgia, and fibromyalgia.
Preclinical studies have shown that HSK16149 has the characteristics of strong analgesia, long-acting analgesia, and small central side effects, which is expected to replace pregabalin and gabapentin, and has the potential to
become the drug of choice for chronic neuropathic pain.
According to the Insight database, HSK16149 was first approved for clinical trials in November 2018, first published for clinical trials in January of the following year, and submitted for marketing
this week.
HSK16149 project development overview
From: Insight Database Web
For diabetic peripheral neuralgia (DPNP), HSK16149 was listed in 20201, according to the Insight database
A multicenter, randomized, double-blind, placebo- and pregabalin capsule-controlled Phase II/III clinical trial (registration number: CTR20202015) to evaluate HSK16149 was published for the first time this month
Efficacy and safety
of capsules in patients with diabetic peripheral neuralgia in China.
The trial included a total of 729 subjects and was completed in September this year
.
CTR20202015 Clinical trial history timeline
From: Insight Database Web
Pain is a common clinical symptom of DPNP, occurring in about 50% of diabetes mellitus and about 13% of
of patients with impaired glucose tolerance seriously affect their normal physical and mental state, with sleep disorders, nutritional disorders, exercise restrictions, and affective disorders, thereby reducing quality of life and ability to
work.
DPNP is an exclusive diagnosis based on clinical presentation, neurological examination, and neuroelectrophysiologic examination on a diagnostic basis or prediabetes
.
At present, although domestic and foreign guidelines recommend a variety of analgesic drug options, DPNP
Patients respond to analgesic therapy to varying degrees, and some patients do not have satisfactory pain control with either monotherapy or combination therapy, and higher doses pose safety concerns
.
And for domestic patients, there are fewer options, the same drug pregabalin
Neither the DPNP indication nor Mindray Bahrain has been approved for marketing
in China.
If HSK16149 can be successfully declared for marketing, it will undoubtedly bring new treatment options
to domestic patients.
In addition to DPNP, HSK16149 is expanding into a number of other indications, and a Phase III clinical study for postherpetic neuralgia has been completed this year7
The enrollment of all subjects was completed in January (registration number: CTR20212551).
The indications for auxiliary analgesia and peripheral neuralgia have also entered the clinical stage
.
New dosage forms/indications for imported drugs have been approved for marketing
New dosage forms/indications for imported drugs have been approved for marketing1.
Novartis: The new specifications/indications of couchimab have been approved for marketing in China
Novartis: The new specifications/indications of couchimab have been approved for marketing in China
October 29
Novartis China announced that two new specifications of its new drug under development, Ke Shanting ® (skuchilumab), have been approved by the National Medical Products Administration - 300 mg
With a carefree pen ® and a 75 mg pre-filled injection needle, the indication for psoriasis in children is extended to moderate to severe plaque psoriasis that meets indications for systemic therapy or phototherapy6
Patients older are no longer restricted
by weight.
by weight.
Psoriasis is an immune-related chronic, recurrent, inflammatory, systemic disease
.
Currently, there are more than 650 in our country
10,000 psoriasis patients
.
Because the disease is not curable, patients need to follow a standardized and reasonable treatment plan for a long time to obtain good disease control and achieve complete clearance
of skin lesions.
In actual clinical treatment, adhering to treatment is a great challenge
for patients.
In June 2020, Keshan Ting ®150 mg
The self-sensing pen ® has been approved in China, and patients can self-inject at home after being guided by a doctor, and will not see the needle during use, reducing injection anxiety and greatly improving patient compliance and treatment experience
.
The usual therapeutic dose for most patients with psoriasis is each time
300 mg, i.
e.
2 single 150 mg subcutaneous injections
.
The approval of the 300 mg Carefree Pen ® enables psoriasis patients to achieve satisfactory symptom control with fewer injections, that is, from a single 2 injections of 150 mg to a single 1 injection of 300
mg
。 A more streamlined treatment approach makes treatment easier for patients
.
In addition, studies have shown that 300 mg of Carefree Pen ® is effective and safe with 2 injections of 150 mg
Similarly, the incidence of adverse reactions at the injection site is less than 0.
1%.
In addition, since 2021, Keshan Ting ® has been approved for psoriasis indications in children and adolescents, weighing less than 50 kg
Many parents are looking forward to the early approval of smaller products
.
75 mg
The approval of the new specifications brings hope to more families of children and can effectively improve the overall quality of life of
children with moderate to severe psoriasis.
In terms of safety, studies have shown that adverse events in psoriasis ® are similar to placebo for 12 weeks, and treatment is continued52
For weeks, no additional/unexpected safety issues
were found in either the low-dose or high-dose treatment groups.
With the approval of the new specifications, Ke Shanting ® has become the only three approved specifications (300 mg, 150 mg, 75) in China
mg), patients can choose different specifications of products according to their own needs under the advice of doctors, and only one injection is required for a single treatment, which helps to promote patients to adhere to standardized medication and achieve a better quality of life
.
Progress in domestic development of couchimumab Gantt chart
From: Insight Database Web
Imported drugs are declared for domestic marketing
Imported drugs are declared for domestic marketing1.
GSK/ViiV Healthcare: Cateteravir was declared and listed in China
GSK/ViiV Healthcare: Cateteravir was declared and listed in China
On October 29, according to the official website of CDE, GSK/ViiV Healthcare HIV
The drug cateteravir injection and cateteravir sodium tablets were declared for marketing in China (acceptance number: JXHS2200098/JXHS2200099).
From: CDE website
Cabotegravir is a long-acting HIV-1 integrase chain transfer inhibitor (INSTI) that works by preventing viral DNA from integrating into human immune cells (T
cells) to inhibit HIV replication
.
According to the Insight database, cateteravir was previously approved by the EMA in December 2020, and has since been approved for marketing
in the United States and Japan.
Domestically, in 2021
First filed for listing
in November.
Key nodes in the development of cateteravir global projects
From: Insight Database Web
According to previously disclosed results of key phase III ATLAS and FLAIR studies, the period was 48
During the week of treatment, a monthly buttock muscle injection of sustained viral suppression combined with a daily oral triple therapy (2 nucleoside reverse transcriptase inhibitors (NRTIs)) plus an integrase inhibitor
(INI), NNRTI, or protease inhibitor (PI)) is the same
.
and 90% of participants reported preferring 1-dose injections per month over previous daily oral therapy
.
Also this week, ViiV Healthcare announced that an EMA has been granted for marketing authorization for Cabotegravir long-acting injections
Admissible for pre-exposure prophylaxis (PrEP) to reduce the risk
of sexually acquired HIV-1.
In terms of HIV prevention, Cabotegravir long-acting injections are administered every 2 after initiation of treatment
Injections are given once a month and only 6 injections
are required throughout the year.
Cabotegravir long-acting injection (CAB LA) was previously used in PrEP and has been approved in the United States, Australia, and Zimbabwe under the trade name Apretude
.
Progress of overseas innovative drugs
Progress of overseas innovative drugsThis week, a total of 9 new drugs (including improved new) research and development progress abroad advanced to a new stage
.
This week's overseas 9 new drugs (including improved new) dynamics
From: Insight Database Web
Approved for listing
Approved for listing1.
Johnson & Johnson: BCMA × CD3 bispecific antibody obtained FDA
Approval for listing
Johnson & Johnson: BCMA × CD3 bispecific antibody obtained FDA Approval for listing
On October 25, Johnson & Johnson announced that its BCMA ×CD3 bispecific antibody Teclistamab (trade name: Tecvayli) has received an FDA
Approved for marketing in the US for the treatment of relapsed/refractory multiple myeloma (R/R MM)
that has previously received fourth-line or more therapy, including proteasome inhibitors, immunomodulators, and anti-CD38 monoclonal antibodies.
Key nodes in the development of Teclistamab projects worldwide
From: Insight Database Web
Teclistamab's approval is based on the Phase I/II clinical trial MajesTEC-1 study (trial registration number: NCT04557098/NCT03145181).
This is a single-arm, open-label, multi-cohort, multicenter dose-escalation study to
ORR is the primary endpoint
.
The pivotal phase II trial included patients who had previously received a median number of lines of therapy (n=110), of whom 78% had received fourth-line therapy or more
.
The overall response rate (ORR) is achieved
61.
8% (95% CI: 52.
1%, 70.
9%), of which 28.
2% had complete or severe complete response (sCR).
The median time to first response was 1.
2 months (range: 0.
2 to 5.
5 months).
Median follow-up was 7.
4 months, estimated 6
Monthly sustained response (DOR) rate was 90.
6% (95% CI: 80.
3%, 95.
7%) and 9-month DOR rate was 66.
5% (95%
CI：38.
8%，83.
9%）
。
2 months (range: 0.
2 to 5.
5 months)
Key clinical evidence approved
From: Insight database
It is worth mentioning that this is the 4th multiple myeloma treatment
approved by Johnson & Johnson.
Of the four multiple myeloma drugs that Johnson & Johnson has approved, CD38 monoclonal antibody daratumumab had 60.
23 global sales in 2021
billion-dollar megablockbuster, and still growing at a high growth rate of 43%; CAR-T therapy cedarciolensis despite year 2
It was just approved in January, but it has a tendency to catch up, and Q3's quarterly sales have reached $55 million, which is still in the high-speed ramp-up period
.
23 sold worldwide in 2021 Billion-dollar megabombshell
From: Insight database
Filing for listing
Filing for listing1.
AbbVie/Genmab: CD3/CD20 bispecific antibody was declared for marketing
AbbVie/Genmab: CD3/CD20 bispecific antibody was declared for marketing
On October 28, AbbVie/Genmab announced that it had submitted an Application for Epcoritamab for Biological Product Licensing (BLA) to the FDA for treatment previously accepted
Adult patients
with relapsed/refractory large B-cell lymphoma (LBCL) after 2-line or multi-line system therapy.
In addition, the EMA has accepted a marketing authorization application (MAA) for Epcoritamab for the treatment of relapsed/refractory (R/R) diffuse large B receiving 2-line or multiline system therapy
Adult patients with
cellular lymphoma (DLBCL).
Eporitamab is a CD3/CD20 bispecific antibody
based on Genmab's proprietary DuoBody technology.
Genmab's
DuoBody-CD3 technology is designed to selectively direct cytotoxic T cells into tumors to trigger an immune response
to malignant cells.
Epcoritamab is designed to bind to T cells at the same time
CD20 on CD3 and B cells and induces T-cell-mediated killing of
targeted lymphoma B cells.
Epcoritamab's regulatory application is based on preliminary results
from a previously disclosed EPCORE NHL-1 Phase II clinical trial in the expanded cohort of large cell lymphoma.
The study cohort included 157 patients with relapsed/refractory LBCL who had previously received a median of 3.
5-line (2-11 lines), of whom 38.
9% had previously received it
CAR-T cell therapy
.
Key outcomes for this cohort showed an objective response rate (ORR) of 63.
1% confirmed by the Independent Review Committee (IRC) and an observed median duration of response (DoR) of 12
months
.
In terms of safety, it is consistent
with previous research results.
EPCORE NHL-1 clinical trial results
From: Insight database
Approved for clinical use
Approved for clinical use1.
Simcere Pharmaceutical: PD-L1/IL-15 bispecific antibody IND application was approved by the FDA
Simcere Pharmaceutical: PD-L1/IL-15 bispecific antibody IND application was approved by the FDA
On October 27, Simcere announced that its self-developed clinical trial application (IND) for SIM0237 injection, an anti-PD-L1/IL-15 bispecific antibody, was approved by the United States
Approved by the Drug Administration (FDA) for the treatment of locally advanced unresectable or metastatic solid tumors
.
SIM0237 is an anti-PD-L1 monoclonal antibody and IL-15/IL-15Rα fusion protein developed based on Simcere's own protein engineering technology platform, which can be blocked by binding to PD-L1
PD1/PD-L1 immunosuppressive pathway, while activating the immune system through IL-15, thus playing a dual synergistic effect of eliminating immunosuppression and activating the immune system, and exerting anti-tumor effects
.
Preclinical studies have shown that SIM0237 is more effective than PD-L1 monotherapy and IL-15 monotherapy in mouse tumor models, and has high clinical development potential
.
Previously, SIM0237's clinical trial application in China was accepted by CDE on October 10 this year (acceptance number: CXSL2200508).
FDA Meeting
FDA MeetingIn addition, last week the US FDA's Cardiovascular and Nephrology Drug Expert Advisory Committee (CRDAC) met to discuss Prolyl hydroxylase, a 3rd oral small molecule hypoxia-inducible factor from GSK
(HIF-PH) inhibitor "daplastat" benefit risk profile to determine whether its NDA application (216951) for the treatment of anemia associated with chronic kidney disease (CKD)) can be approved
.
For dialysis-dependent patients, the FDA believes that its efficacy is similar to that of the mature drug erythropoietin (ESA) and does not increase the safety risk, but the significance of the first oral drug is questionable; For nondialysis patients, FDA
It means that daplastat increases the additional risk of cardiovascular and stroke, and oral drugs are not conducive to disease management
.
The results of the vote showed that experts gave opposite opinions on the two indications, with the indication for dialysis-dependent patient groups winning 13:3 from experts
Experts believe that the first oral drug has positive significance for this part of the unmet medical needs, and under the excellent efficacy, the convenience of oral administration helps to reduce the burden on doctors and patients and medical costs
.
The indication for non-dialysis-dependent patient groups was opposed 11:5, with experts arguing that the benefit was not enough to offset
the increased safety risks.
Although the voting results are mixed, if daplastat can debut first in the indication of DD-CKD-related anemia, it will be HIF-PHI
A breakthrough
in the US market.
In fact, taking roxadustat as an example, the drug was first approved in dialysis-dependent patients in China and Japan, and then expanded the indication to non-dialysis-dependent people
.
in the US market.
