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

Since 2022, the international situation is severe and complex, the epidemic continues to progress, China's pharmaceutical industry has inevitably been affected, up to now, the State Medical Products Administration has approved 42 new drugs (excluding traditional Chinese medicine, new indications), and another 6 new crown pneumonia vaccines have been included in emergency use, the number has decreased significantly compared with the previous year, and the listing of some blockbuster new drugs has greatly met the clinical needs of domestic cancer and rare disease patients, such as cardunilimab, gosatuzumab, traracicillide, lalotinib, etc
。 As 2022 draws to a close, Pharma Cube will sort out the blockbuster new drugs that have greater hopes of being approved and marketed in China in 2023 for your reference
.
Oncology field

In 2023, the super blockbuster detrostuzumab in the field of oncology will be launched in China, Hengrui Pharmaceutical's innovative drugs are expected to exceed 15, Iquilencel and Zewauk Orscel will compete for China's first BCMA CAR T cell therapy, and jackitinib developed by Zejing Pharmaceutical is expected to become the first approved domestic original JAK inhibitor
.

1.
Detrostuzumab (Enhertu)

Estimated approval time: 2023Q1

Detrostuzumab is an HER2-targeting antibody conjugate drug (ADC) developed by Daiichi Sankyo, using proprietary DXd-ADC technology, composed of humanized anti-HER2 lgG1 antibody, cleavable tetrapeptide linker and topoisomerase I inhibitor (camptothecin derivative DXd), which has the dual advantages
of precise targeting, high efficiency and low toxicity.
In March 2019, AstraZeneca acquired the co-development rights
of dtrostuzumab outside of Japan with an upfront payment of $1.
35 billion and a milestone payment of $5.
55 billion.

Detrostuzumab has been approved for the treatment of HER2-positive breast cancer in more than 30 countries and regions including the United States and the European Union, and was approved in the United States in August this year for the treatment of unresectable or metastatic HER2 hypo-expression (IHC1+ or IHC 2+/ISH-) breast cancer, becoming the only HER2-targeted therapy
approved for HER2-low expression breast cancer.

Source: NextPharma® Database - Approved Indications In 2021, sales of dtrostuzumab were approximately $550 million
。 Daiichi Sankyo submitted a marketing application (JXSS2200011) for the treatment of HER2-positive breast cancer to the NMPA in March 2022 and was included in the priority review and approval process, and submitted a marketing application for HER2 low-expression breast cancer (JXSS2200033) in August 2022, which is the first drug in China for people with HER2 low expression in metastatic breast cancer, and both applications are currently in the
。

2.
Adelibrelimab

Estimated approval time: 2023Q1

Adelibilimab is a humanized PDL1-targeting monoclonal antibody independently developed by Hengrui Pharmaceutical, and 4 registered phase III clinical trials
have been carried out in China for small cell lung cancer (extensive and limited) and non-small cell lung cancer (neoadjuvant and adjuvant).
In addition, indications for esophageal squamous cell carcinoma, breast cancer, hepatocellular carcinoma and other indications are in the early clinical stage
.

Source: NextPharma® Database - Indications Progress

Results from a randomized, double-blind, placebo-controlled, multicenter phase III.
clinical trial (SHR-1316-III.
-301) of adebelimab combined with chemotherapy in the first-line treatment of extensive-stage small cell lung cancer showed that adebelimab plus chemotherapy significantly prolonged survival (mOS: 15.
3 vs 12.
8 months).

。 At present, two anti-PDL1 monoclonal antibodies (durvalimab, atezolizumab) have been approved in China for the treatment of small cell lung cancer, and adebelimab was submitted in January 2022 for the marketing application of small cell lung cancer (CXSS2200006), which is currently in a round of supplementation stage
.

3.
Iquilensai (Forcosa)

Estimated approval time: 2023Q3

Iquilencel is a CAR-T cell therapy for BCMA developed by Reindeer Medical and Innovent Biologics, using lentivirus as the gene vector to transfect autologous T cells, CAR containing fully human scFv, CD8a hinge and transmembrane, 4-1BB co-stimulation, and CD3ζ-activating domains
.
The fully human BCMA antibody sequence enables the product to have extremely low immunogenicity and long-lasting in vivo CAR-T amplification and survival
.

Source: NextPharma® Database - Basic Drug Information

The results of the Phase I/II registration clinical trial (NCT05066646) showed that Iquilencel had excellent safety and efficacy in humans, and the ORR of 79 patients with multiple myeloma who underwent at least third-line therapy was 94.
9% and CR/sCR was 58.
2%.

Iquilencel for the treatment of relapsed/refractory multiple myeloma was included in the CDE breakthrough therapy list and was awarded orphan drug
designation by the FDA.
In June 2022, Reindeer Medical submitted the marketing application (CXSS2200055) of Iquilencel for the treatment of multiple myeloma to the NMPA, and was included in the priority review and approval process, which is the first autologous CAR-T cell product
targeting BCMA in China.

4.
Zevorcabtagene Autoleucel

Estimated approval time: 2023Q4

Zewauki Orencel is an autologous fully human anti-BCMA CAR-T cell product, which integrates the upgraded CAR structure of CARsgen Pharmaceutical, with low immunogenicity and high stability, fully human anti-BCMA-specific single-chain antibody with low immunogenicity and high stability, which can reduce the automatic activation
of CAR cells in the absence of tumor-related targets.
Previously, it was designated as a dual breakthrough therapy by NMPA and EMA for the treatment of relapsed/refractory multiple myeloma, and was awarded orphan drug designation by the FDA and EMA
.

At ASH 2022, CARsgen Pharmaceuticals announced the results of a phase II clinical trial (CT053-MM-01), in which 102 patients with multiple myeloma who underwent at least third-line therapy had a treated ORR of 92.
8% and a CR/sCR of 42.
2%.

Source: NextPharma® Database - Clinical Results

The drug was submitted in October 2022 for the treatment of multiple myeloma (CXSS2200084) and is currently in the review stage, and is expected to be approved
in 2023Q4.

5.
Jacktinib (Zeppin)

Estimated approval time: 2023Q4

Jacktinib is a new JAK inhibitor independently developed by Zelgen Pharmaceutical, which has a significant inhibitory effect on Janus kinases including JAK1, JAK2, JAK3 and TYK2, and has the strongest
inhibitory effect on JAK2 and TYK2.
Jacktinib tablets for the treatment of myelofibrosis were granted orphan drug designation
by the FDA.
Jacktinib cream has been carried out in phase I/II clinical trials
for the treatment of mild to moderate alopecia areata and mild and moderate atopic dermatitis in China.

Source: NextPharma® Database - R&D Progress in China

The phase III clinical trial (NCT04617028) of jacktinib versus hydroxyurea in patients with intermediate- and high-risk myelofibrosis achieved with effective clinical results
.
At 24 weeks of treatment, SVR35 was significantly elevated by 72.
3% and 17.
4% (p<0.
0001),<b11> respectively.

In October 2022, Zejing Pharmaceutical submitted a marketing application for jacktinib for the treatment of intermediate and high-risk myelofibrosis (CXHS2200054) to the NMPA, and is expected to be launched in China in 2023Q4, which is expected to become the first domestic JAK inhibitor
to be marketed.

The field of autoimmune diseases

JAK targeted drugs have an important position in the field of oncology and autoimmune disease treatment, 5 products have been approved in China, and it is expected that many products will be approved in 2023, and the indications continue to expand
to the field of autoimmune diseases.

1.
Deuterium colesitinib (Sotyktu)

Estimated approval time: 2023Q3

Deuterium Colecoxitinib is a TYK2 inhibitor developed by Bristol-Myers Squibb, acting on the pseudokinase domain of TYK2, with high selectivity, and has been developed for the treatment of plaque psoriasis, systemic lupus erythematosus, ulcerative colitis and other autoimmune diseases
.
Deuterium colesitinib was approved in the United States in September 2022 for the treatment of moderate to severe plaque psoriasis, the first oral therapy approved for this indication in nearly a decade and the only approved TYK2 inhibitor
in the world.

The results of two phase III clinical trials POETYK PSO-1 (NCT03624127) and POETYK PSO-2 (NCT03611751) for the treatment of moderate to severe plaque psoriasis showed that the PASI 75 of deuterium colescitinib vs aplimister versus placebo reached 58% vs 35% vs 13% and 53% vs 40% vs 9%,
respectively, after 16 weeks of treatment.

Bristol-Myers Squibb submitted a marketing application for deuterated colecoxitinib for the treatment of moderate to severe plaque psoriasis to the NMPA in July 2022 (JXHS2200061), with the release expected in
China in 2023Q3.

Source: NextPharma® Database - R&D Progress in China

2.
Ritexitinib (ritlecitinib)

Estimated approval time: 2023Q4

Riterxitinib is a selective inhibitor of JAK3 developed by Pfizer that covalently binds to JAK3-specific Cys909 residues to distinguish it
from other JAK isotypes.
The treatment of ritexitinib for alopecia areata has been recognized as a breakthrough therapy in China and the United States, and it has been included in the list
of breakthrough therapy varieties by CDE for ulcerative colitis.

More than 40 clinical trials have been conducted worldwide, and the results of the phase IIb/III clinical trial ALLEGRO (NCT03732807) for the treatment of alopecia areata showed that after 24 weeks of treatment, riterxitinib vs placebo significantly increased the proportion of patients who achieved an absolute SALT score of ≤20, and the trial achieved the primary endpoint
of improving scalp hair regrowth.

Source: NextPharma® Database - Global Clinical Trials

Pfizer submitted a marketing application for riterxitinib for the treatment of alopecia areata (JXHS2200081) to the NMPA in September 2022, and was included in the priority review and approval process in November and is currently in the review stage, which is expected to become the first JAK inhibitor
for the treatment of alopecia areata in China.

3.
Pixietinib (Smyraf)

Estimated approval time: 2023Q4

Pixietinib is a selective inhibitor
of JAK3 developed by Astellas Pharma.
In 2016, Astellas Pharma partnered with Maruho to jointly develop and commercialize topical formulations of piciltinib for the treatment of skin diseases, and Astellas Pharma retained the global rights to
piciltinib for the treatment of rheumatoid arthritis.
Picilitinib was approved in Japan in March 2019 for the treatment of rheumatoid arthritis
.

Source: NextPharma® Database - Trading & Equity

The results of a phase III clinical trial of picitinib for the treatment of rheumatoid arthritis (NCT02308163) showed that the ACR20 of picitinib vs etanercept vs placebo was 74.
5% vs 83.
5% vs 30.
7%
for 12 weeks of treatment in patients who did not respond adequately to DMARDs 。 A phase III clinical trial (CTR20181199) of piciltinib in China, including a total of 385 patients, evaluated the safety and efficacy of piciltinib in patients with rheumatoid arthritis who do not respond adequately or are intolerant to methotrexate, and the trial reached the primary endpoint
of ACR20 response rate at week 24 in April 2021.

Astellas Pharma submitted a marketing application for piciltinib for the treatment of rheumatoid arthritis (JXHS2200073) to the NMPA in August 2022, which is currently under review and is expected to be approved
in 2023Q4.

The field of anesthesia and analgesia

MNC companies pay more attention to the migraine field, while domestic pharmaceutical companies pay less attention, and in 2023, China's migraine treatment field will usher in a number of heavy imported products
.
In terms of postoperative analgesia, the MOR biased agonists of Enhua Pharmaceutical and Hengrui Pharmaceutical are expected to be marketed, bringing faster pain relief and better safety
to patients.

1.
Nurtec, Vydura

Estimated approval time: 2023Q4

Remegipan, a small molecule CGRP receptor antagonist originally developed by Bristol-Myers Squibb and later licensed to Biohaven, on May 10, 2022, Pfizer announced the acquisition of Biohaven for $11.
6 billion to obtain a variety of CGRP therapies
, including remegipam.

Remegirpam was first marketed in the United States in February 2020 for the acute treatment of migraine in adults, and expanded to prevent episodic migraine
in adults in May 2021.
In April this year, remegepam was launched in the European Union for the acute treatment of migraine and the prevention
of episodic migraine.
Remegirpam is the first CGRP drug
to be effective in both acute treatment and prevention of migraine.

Source: NextPharma® Database - Corporate Mergers and Acquisitions

Remegirpan tablets were first approved for clinical trials in China in March 2020, and applied for marketing in September this year (JXHS2200074), and are expected to be approved
in China in Q4 2023.

2.
Erenumab（Aimovig）

Estimated approval time: 2023Q2

Erenumab is a fully human monoclonal antibody
developed by Amgen and Novartis to prevent migraine by blocking CGRP.
In May 2018, Erenumab was approved by the FDA for marketing, becoming the world's first approved antibody drug against CGRP receptors; It was launched in the European Union in July 2018 and in Japan in June 2021
.

Source: NextPharma® Database - Pharmaceutical Transactions

In October 2021, Novartis announced that the DRAGON Phase III study met the primary endpoint, and the Erenumab 70mg group was significantly better than the placebo group in the last 4 weeks of the 12-week double-blind treatment period compared to the baseline reduction in the number of days of migraine per month
.
In addition, the Erenumab 70 mg group had a significantly higher response rate than a 50% reduction in migraine days per month compared to baseline
.

On April 7, 2022, the marketing application of Erenumab injection was accepted for the prevention of migraine in adults, and it is expected that Q2 2023 will be approved
in China.

3.
Galcanezumab (Emgality) Estimated Approval Time: 2023 Q4

Galcanezumab is a fully human monoclonal antibody
targeting CGRP developed by Eli Lilly.
In September 2018, Galcanezumab was first launched in the United States for the preventive treatment of migraine; In June 2019, it was approved for the treatment of paroxysmal cluster headache
in adults.
Since its listing, Galcanezumab sales have continued to grow rapidly, with sales of $577 million in 2021, up 59%
year-over-year.

Source: NextPharma® Database - Sales Data

On July 26, 2022, the marketing application of Galcanezumab injection was accepted, presumably for the preventive treatment of adult episodic migraine
.

4.
Lasmiditan Estimated Approval Time: 2023Q1

Lamiditan is a high-affinity and highly selective 5-HT1F receptor agonist developed by Eli Lilly that has a low affinity for 5-HT1B receptors and therefore does not cause vasoconstriction
.
Ramiditan was first marketed in the United States in October 2019 as the first 5-HT1F receptor agonist approved by the FDA, and was later approved in Japan and the European Union in 2022 for the acute treatment
of migraine.

Source: NextPharma® Database - Approved Indications

Eli Lilly's two randomized, double-blind, placebo-controlled phase III clinical trials of SAMURAI (NCT02439320) and SPARTAN (NCT02605174) showed a significant increase in the proportion of patients with complete disappearance of headache after 2 hours of lamiditan compared with placebo, while migraine symptoms, such as nausea and sound and light sensitivity
, were also significantly absent in other most bothersome patients.

On January 29, 2022, the official website of CDE showed that Eli Lilly submitted a marketing application for lamiditan tablets (lasmiditan) in China for the acute treatment of migraine attacks, which is currently in a round of replenishment stage
.

5.
Olinvo

Estimated approval time: 2023Q1

Oxylidine is a first-in-class small molecule G protein biased μ-opioid receptor (MOR) agonist developed by Trevena, which can reduce the activation
of adverse reaction signaling pathways while preferentially activating analgesic signaling pathways.

Aucelli is scheduled to be approved in the United States in 2020 for the treatment of moderate to severe acute pain
in adult patients who require intravenous opioids and inadequate substitution therapy.
In May 2018, Enhua entered into a license agreement with Trevena to acquire exclusive rights
to develop and commercialize the product in Greater China.

Source: NextPharma® Database - Pharmaceutical Transactions

Oxelidine is currently the fastest progressing MOR biased agonist in China, and is expected to be approved for marketing
in China in 2023Q1.

6.
SHR8554

Estimated approval time: 2023Q3

SHR8554 is a MOR-biased agonist independently developed by Hengrui Pharmaceutical, which is used to treat moderate to severe pain
after abdominal surgery.
Opioids are the most commonly used
drugs for the treatment of moderate to severe acute and chronic pain.
At present, there are no biased MOR agonists with good analgesic effect and low incidence of adverse reactions on the market
in China.

In July, the marketing application for SHR8554 was accepted, based on data from a Phase III clinical trial (NCT04766463) designed to evaluate the efficacy and safety of SHR8554 in the treatment of analgesia after abdominal surgery, which met the protocol's predetermined efficacy criteria
.

Cardiovascular and cerebrovascular and metabolic fields

In the past two years, the excellent effects of semeglutide and telpotide in the field of diabetes and obesity have attracted attention, and the market for related products in the field of metabolism is expected to continue to rise, as a number of domestic anti-PCSK9 monoclonal antibodies enter the late stage of development, the treatment pattern of hypercholesterolemia will undergo obvious changes
.

1.
Tilpotide (Mounjaro)

Estimated approval time: 2023Q4

Tilpotide is a GIP and GLP-1 dual-target receptor agonist developed by Eli Lilly, which integrates the effects of two incretin insulins into a new molecule, and was approved in the United States in May 2022 for the treatment of type II diabetes, the first new type II diabetes drug
in nearly a decade.

Telpotide achieved a better reduction in HbA1c than various positive drugs (including semeglutide, dulaglutide, insulin glargine, and insulin degludec) in the phase III SURGE test
.
Eli Lilly has high hopes for telpotide and has already conducted several core clinical trials for type II diabetes and obesity, and in October 2022, Eli Lilly conducted a large phase III clinical trial of telpotide for reducing cardiovascular risk in obese patients, with an expected enrollment of 15,000 subjects
.

Source: NextPharma® Database - Core Clinical

According to Eli Lilly's Q3 financial report, telpotide has been approved for less than half a year, and its sales have exceeded 200 million US dollars
.
On September 7, 2022, telpotide was declared for marketing in China, and it is expected to be approved
in 2023Q4.

2.
Toleximab (tafolecimab)

Estimated approval time: 2023Q3

Tolesimab is an anti-PCSK9 monoclonal antibody independently developed by Innovent for the treatment of primary hypercholesterolemia and mixed dyslipidemia
.
Tolesimab increases LDLR levels by specifically binding to PCSK-9 molecules by reducing PCSK-9-mediated low-density lipoprotein receptor (LDLR) endocytosis, which in turn increases LDL-C clearance and decreases LDL-C levels
.

In February this year, two key Chinese registered clinical studies of tolesimab, the CREDIT-1 and CREDIT-4 trials, both met the primary endpoint
.
Compared with placebo, tolesimab can reduce LDL-C levels by about 57%~65%, and can maintain long-term treatment efficacy
.

Source: NextPharma® database - PCSK9 indication R&D layout

Tolesimab is the first domestic anti-PCSK9 monoclonal antibody declared for marketing, in addition, the anti-PCSK9 monoclonal antibody of Akeso, Hengrui Pharmaceutical, and Junshi Biologics are all in the phase 3 clinical stage
.
On June 13, 2022, the marketing application for tolesimab was accepted and is currently in line for review
.

3.
Inclisiran（Leqvio）

Expected approval time: 2023 Q4

Inclisiran, a first-in-class long-acting PCSK9 siRNA drug developed by Alnylam and The Medicines Company, acquired The Medicines Company in 2019 for approximately $9.
7 billion and acquired global rights
in Inclisiran.

Inclisiran was first approved in the European Union in December 2020 for the treatment of primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia
in adults.
On December 22, 2021, the FDA approved Inclisiran for the adjuvant treatment of patients
with atherosclerosis or heterozygous familial hypercholesterolemia.

Source: NextPharma® Database - Knowledge Cards

The pivotal phase III ORION (ORION-9, -10, and -11) study showed that inclisiran reduced LDL-C by 52% compared with placebo for 17 months in patients who were unable to achieve LDL-C after treatment with the maximum tolerated dose statin, and it was well
tolerated.
In addition, Inclisiran's dosing regimen, which requires only two injections per year after the initial treatment at the first and third month of treatment, is expected to address the patient's long-term compliance dilemma
.

Ophthalmology and rare diseases

The field of ophthalmology and rare diseases is attracting more and more attention, and the innovative drugs currently listed in China are mainly imported products, and Zai Lab, CANbridge, Langhua Pharmaceutical, etc.
have accelerated the domestic listing of imported drugs through license-in to meet the needs
of domestic patients as soon as possible.

1.
Faricimab（Vabysmo）

Estimated approval time: 2023Q4

Faricimab, a Roche-developed Ang2/VEGF-A bispecific antibody for ophthalmic diseases, is the first wet AMD and DME drug with a flexible dosing regimen based on patient needs, ranging from once a month to once every four months, compared to standard therapies (ranibizumab, aflibercept) that typically require once a month or two months
.

Faricimab was first launched in the United States on January 28, 2022 for the treatment of diabetic macular edema and wet age-related macular degeneration, becoming the first dual antibody for the treatment of ophthalmic diseases; In March 2022, it was approved for listing in Japan; In September 2022, it was approved for listing
in the European Union.

Source: NextPharma® - Basic Information

Results from two Phase 3 trials for diabetic macular edema, YOSEMITE and RHINE, showed that faricimab Q16W vs aflibercept Q16W achieved non-inferiority in visual acuity improvement, with more than half of patients achieving a 16-week treatment cycle in the first year, the first time such a level of persistence has been achieved in a Phase 3 trial
.

The results of two other phase 3 trials for the treatment of wet age-related macular degeneration, TENAYA and LUCERNE, showed that faricimab 6.
0 mg Q16W was not inferior to aflibercept 2.
0 mg Q8W in terms of visual acuity improvement, and the trial met the primary endpoint
.
In August 2022, Faricimab filed for listing in China, and is expected to be listed
in China in Q4 2023.

2.
Agamod α (Vyvgart)

Estimated approval time: 2023Q3

Agamod α is the world's first antibody fragment targeting FcRn developed by Argenx, derived from Fc fragment of IgG1, modified by ABDEG mutation to increase the affinity for FcRn at physiological and acidic pH
.
In January 2021, Zai Lab acquired an exclusive license
to develop and commercialize Agamod α in Greater China for a total transaction value of US$175 million.

The results of the phase III clinical trial ADAPT (NCT03669588) of Agamod α for the treatment of generalized myasthenia gravis showed that the proportion of AChR antibody positive patients who received Agamod α versus placebo for myasthenia gravis MG-ADL score was 68% versus 30%.

Agamod α was first approved by the FDA in December 2021 for the treatment of systemic myasthenia gravis in AChR antibody-positive patients, and was approved
in Japan and the European Union in 2022.
Zai Lab submitted a marketing application (JXSS2200022) for the treatment of generalized myasthenia gravis (α JXSS2200022) to the NMPA in July 2022
.

3.
Mahibat (Mairibe)

Estimated approval time: 2023Q1

Macibat is the first and only FDA-approved ISBT inhibitor for the treatment of Alagille syndrome-associated cholestatic pruritus, which was approved
in the United States in September 2021.
In April 2021, CANbridge and Mirum entered into a $130 million partnership transaction to develop and commercialize mahibat in Greater China for the treatment of Alagille syndrome, progressive familial intrahepatic cholestasis, and biliary atresia
.

Alagille syndrome is a rare genetic disorder characterized by abnormal narrowing, deformity, and scarcity of the biliary tract, with bile accumulating in the liver causing liver damage, followed by yellowing of the skin and whites of the eyes (jaundice), itching of the skin and deposition of skin cholesterol (xanthelasma), usually occurring in infancy
.

Source: NextPharma® Database - Disease-Related Drugs

Maxibat submitted a marketing application (JXHS2200015) for the treatment of Alagille syndrome in January 2022 and was included in the priority review and approval process, and is currently in the first round of supplementary issuance
.