YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 305 drug applications between 19 October 2024 and 25 October 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 97, covering 68 drug names.

2024/10/19 – 2024/10/25

Period
2024/10/19 to 2024/10/25, 7 days inclusive
Data as of
2026/11/13 06:00
Cached records
94,806 acceptance records, 11,656 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
305
Drugs with new generic filings (by drug name, de-duplicated)
68
Accepted this week, now under review
1

DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.

Names with a public page are linked.

New acceptances this week

By application type and drug type

305filings, 97 of them generic

By application type

Application typeFilings
Supplement137
Generic97
New drug45
Import14
Unspecified10
Import re-registration2

By drug type

Drug typeFilings
Chemical drug195
TCM59
Therapeutic biologic35
Biologic9
Prophylactic biologic7

DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.

Most new generic filings, by drug

68 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Methotrexate Injection6111
2维生素B6注射液 · No verified English name4410
3Vonoprazan Fumarate Tablets4260
4Bilastine Oral Solution228
5Famotidine Injection228
6Landiolol Hydrochloride for Injection2219
7Lactulose Oral Solution2134
8Perampanel Tablets212
9Olmesartan Medoxomil Orally Disintegrating Tablets210
10Levocarnitine Oral Solution219

DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.

Most new acceptances, by company

188 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shenyang Dong Xin Pharma Co., Ltd. romanized980
2Guangdong Sunho Pharmaceutical Co., Ltd.740
3Haerbin Yu Heng Pharmaceutical Co., Ltd. romanized616
4Jilin Sheng Shang Cheng Pharma Co., Ltd. romanized540
5Novo Nordisk A/S510
6Sanofi-Aventis Recherche & Développement440
7Hua Chuan Pharmaceutical Co., Ltd. romanized440
8Beijing Bai Yi Wu You Technology Development Co., Ltd. romanized430
9Chengdu Nuo He Cheng Hong Biopharmaceutical Co., Ltd. romanized434
10AstraZeneca AB420

DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.

Under-review list changes

Compared across this platform's snapshots of the under-review list

Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.

DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.

Class 3 and new-drug acceptances

103 this week

AcceptedDrugApplicants
2024/10/25Import · Class 1 S095029 · No verified English nameJXSL2400204 Institut de Recherches Internationales Servier; Servier (Beijing) Pharmaceutical Research & Development Co. LTD
2024/10/25Import · Class 2.4 Osimertinib Mesylate TabletsJXHL2400258 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2024/10/25Import · Class 2.4 Osimertinib Mesylate TabletsJXHL2400257 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2024/10/25Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2403632 Shandong Qidu Pharmaceutical Co., Ltd.
2024/10/25Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2403631 Shandong Ji Kun Biopharmaceutical Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanized
2024/10/25Generic · Class 3 Betamethasone Sodium Phosphate InjectionCYHS2403629 Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized
2024/10/25Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2403625 Xian An Jian Pharma Co., Ltd. romanized
2024/10/25Generic · Class 3 Progesterone InjectionCYHS2403624 Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized
2024/10/25Generic · Class 3 羧甲司坦干糖浆 · No verified English nameCYHS2403623 Kang Zhi Pharma Co., Ltd. romanized
2024/10/25Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2403622 Wen Ling Shi Innovation Biopharmaceuticals Technology Co., Ltd. romanized; Wan Bang De Pharmaceutical Group Co., Ltd. romanized
2024/10/25Generic · Class 3 法罗培南钠片 · No verified English nameCYHS2403621 HUNAN WARRANT PHARMACEUTICAL CO.,LTD
2024/10/25Generic · Class 3 Famotidine InjectionCYHS2403617 Nanjing Huang Long Bio Technology Co., Ltd. romanized; Sichuan Hong Ming Bo Si Pharma Co., Ltd. romanized
2024/10/25Generic · Class 3 Epinephrine InjectionCYHS2403616 Chengdu Nuo He Cheng Hong Biopharmaceutical Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2024/10/25Generic · Class 3 Sucralfate Oral SuspensionCYHS2403610 Heilongjiang Zhong Gui Pharmaceutical Co., Ltd. romanized
2024/10/25Generic · Class 3 Sucralfate Oral SuspensionCYHS2403608 Heilongjiang Zhong Gui Pharmaceutical Co., Ltd. romanized
2024/10/25Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2403607 Xizang Ao Si Bi Xiu Pharmaceuticals Co., Ltd. romanized; HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.
2024/10/25Generic · Class 3 Hydromorphone Hydrochloride InjectionCYHS2403606 Qinghai Pharmaceutical Co., Ltd. romanized
2024/10/25New drug · Class 1 注射用SIM0505 · No verified English nameCXSL2400729 Shanghai Xian Xiang Pharmaceuticals Technology Co., Ltd. romanized
2024/10/25New drug · Class 1 GD-N2203灌肠液 · No verified English nameCXHL2401130 Sichuan Hao Yi Sheng Pan Xi Pharma Co., Ltd. romanized
2024/10/25New drug · Class 1 GD-N2203灌肠液 · No verified English nameCXHL2401129 Sichuan Hao Yi Sheng Pan Xi Pharma Co., Ltd. romanized
2024/10/25New drug · Class 1 OB756片 · No verified English nameCXHL2401128 Hangzhou Bang Shun Pharmaceutical Co., Ltd. romanized
2024/10/24Import · Class 1 SAR442970注射液 · No verified English nameJXSL2400203 Sanofi-aventis recherche & développement; Sanofi (China) Investment Co. Ltd.
2024/10/24Import · Class 1 SAR441566 · No verified English nameJXHL2400256 Sanofi-Aventis Recherche & Développement; Sanofi(China)Investment Co. Ltd.
2024/10/24Import · Class 1 Rilzabrutinib片 · No verified English nameJXHL2400255 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2024/10/24Generic · Class 3 Clemastine Fumarate InjectionCYHS2403599 Chengdu Nuo He Cheng Hong Biopharmaceutical Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized
2024/10/24Generic · Class 3 托吡酯口服溶液 · No verified English nameCYHS2403596 Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2024/10/24Generic · Class 3 枸橼酸西地那非口溶膜 · No verified English nameCYHS2403593 Shanghai Xin Feng Pharmaceutical Co., Ltd. romanized
2024/10/24Generic · Class 3 枸橼酸西地那非口溶膜 · No verified English nameCYHS2403592 Shanghai Xin Feng Pharmaceutical Co., Ltd. romanized
2024/10/24Generic · Class 3 氯化钙注射液 · No verified English nameCYHS2403588 Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2024/10/24Generic · Class 3 酮洛芬凝胶贴膏 · No verified English nameCYHS2403587 Nanjing Hai Na Pharmaceutical Co., Ltd. romanized

73 more not listed (at most 30 rows).

DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.

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