YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 341 drug applications between 18 October 2024 and 24 October 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 88, covering 68 drug names.

2024/10/18 – 2024/10/24

Period
2024/10/18 to 2024/10/24, 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
341
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

341filings, 88 of them generic

By application type

Application typeFilings
Supplement158
Generic88
New drug58
Import23
Unspecified12
Import re-registration2

By drug type

Drug typeFilings
Chemical drug194
TCM78
Therapeutic biologic50
Prophylactic biologic10
Biologic9

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
1Bumetanide Injection3213
2匹伐他汀钙口崩片 · No verified English name310
3Bilastine Oral Solution228
4Landiolol Hydrochloride for Injection2219
5Lactulose Oral Solution2134
6Tacrolimus Sustained-release Capsules216
7Perampanel Tablets212
8Olmesartan Medoxomil Orally Disintegrating Tablets210
9Vonoprazan Fumarate Tablets2160
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

214 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shenyang Dong Xin Pharma Co., Ltd. romanized770
2Shaanxi Sun Si Miao Gao Xin Pharmaceutical Co., Ltd. romanized660
3Eli Lilly and Company610
4Jilin Sheng Shang Cheng Pharma Co., Ltd. romanized540
5AstraZeneca AB530
6Novo Nordisk A/S510
7Sanofi-Aventis Recherche & Développement440
8Hua Chuan Pharmaceutical Co., Ltd. romanized440
9Beijing Bai Yi Wu You Technology Development Co., Ltd. romanized430
10Bayer AG420

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

124 this week

AcceptedDrugApplicants
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
2024/10/24Generic · Class 3 Hydrocortisone Sodium Succinate for InjectionCYHS2403585 Hainan Wei Jian Pharma Co., Ltd. romanized; Chongqing Lai Mei Pharma Co., Ltd. romanized
2024/10/24Generic · Class 3 Hydrocortisone Sodium Succinate for InjectionCYHS2403584 Hainan Wei Jian Pharma Co., Ltd. romanized; Chongqing Lai Mei Pharma Co., Ltd. romanized
2024/10/24Generic · Class 3 Landiolol Hydrochloride for InjectionCYHL2400210 Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized
2024/10/24New drug · Class 1.2 苦丁茶总皂苷提取物 · No verified English nameCXZL2400069 Hua Yi Shen Nong (Zhuhai) Pharmaceuticals Technology Co., Ltd. romanized; Beijing University romanized; Chongqing Shi Zhong Yao Research Institute (Chongqing Shi Zhong Yao Bo Wu Guan) romanized
2024/10/24New drug · Class 1.2 苦丁茶皂苷片 · No verified English nameCXZL2400068 Hua Yi Shen Nong (Zhuhai) Pharmaceuticals Technology Co., Ltd. romanized; Beijing University romanized; Chongqing Shi Zhong Yao Research Institute (Chongqing Shi Zhong Yao Bo Wu Guan) romanized
2024/10/24New drug · Class 1.1 膝痛颗粒 · No verified English nameCXZL2400067 Zhong Yi (Guangzhou) Technology Innovation Research Co., Ltd. romanized; Zhongguo Zhong Yi Ke College Zhong Yao Research Institute romanized
2024/10/24New drug · Class 3.3 流感病毒裂解疫苗 · No verified English nameCXSS2400114 Anhui Zhi Fei Long Ke Ma Biopharmaceutical Co., Ltd. romanized
2024/10/24New drug · Class 2.2 拓培非格司亭注射液 · No verified English nameCXSL2400728 Xiamen Te Bao Bio Gong Cheng Co., Ltd. romanized
2024/10/24New drug · Class 1 注射用YK012 · No verified English nameCXSL2400727 Yi Ke Si Te (Beijing) Pharmaceuticals Technology Development Co., Ltd. romanized
2024/10/24New drug · Class 2.2 甲型肝炎灭活疫苗(人二倍体细胞) · No verified English nameCXSL2400726 Zhejiang Pu Kang Bio Technology Co., Ltd. romanized
2024/10/24New drug · Class 2.2 甲型肝炎灭活疫苗(人二倍体细胞) · No verified English nameCXSL2400725 Zhejiang Pu Kang Bio Technology Co., Ltd. romanized
2024/10/24New drug · Class 1 注射用MHB009C · No verified English nameCXSL2400724 Ming Hui Pharmaceuticals (Hangzhou) Co., Ltd. romanized
2024/10/24New drug · Class 1 注射用SLN12140 · No verified English nameCXSL2400723 Ling Nuo (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2024/10/24New drug · Class 2.2 JSS-221 · No verified English nameCXHL2401127 Jiangxi Shimei Pharmaceutical Co., Ltd
2024/10/24New drug · Class 1 WA01片 · No verified English nameCXHL2401126 Nuo Wei Bio Technology (Wuxi) Co., Ltd. romanized; Nuo Wei Technology (Beijing) Co., Ltd. romanized
2024/10/23Import · Class 1 ADI-001 · No verified English nameJXSL2400202 Adicet Therapeutics Inc.; Shanghai Adicet Biotechnology Co. Ltd.
2024/10/23Import · Class 2.2 注射用Belantamab mafodotin · No verified English nameJXSL2400201 GlaxoSmithKline Trading Services Limited; GlaxoSmithKline (China) Investment Co. Limited
2024/10/23Import · Class 1 Itepekimab注射液 · No verified English nameJXSL2400200 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2024/10/23Import · Class 1 Frexalimab注射液 · No verified English nameJXSL2400199 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2024/10/23Generic · Class 3 Famotidine InjectionCYHS2403583 Shi Yao Yin Hu Pharmaceutical Co., Ltd. romanized
2024/10/23Generic · Class 3 Methocarbamol InjectionCYHS2403582 Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized

94 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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