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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 529 drug applications between 10 October 2024 and 16 October 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 158, covering 114 drug names.

2024/10/10 – 2024/10/16

Period
2024/10/10 to 2024/10/16, 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
529
Drugs with new generic filings (by drug name, de-duplicated)
114
Accepted this week, now under review
3

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

529filings, 158 of them generic

By application type

Application typeFilings
Supplement225
Generic158
New drug89
Import31
Import re-registration14
Unspecified12

By drug type

Drug typeFilings
Chemical drug376
TCM86
Therapeutic biologic62
Biologic3
Prophylactic biologic2

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

114 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Fusidic Acid Cream6315
2Magnesium Sulfate, Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution338
3Vonoprazan Fumarate Tablets3260
4Hydrocortisone Sodium Succinate for Injection3216
5Bupivacaine Hydrochloride Injection314
6Fudosteine oral solution317
7Dasatinib Tablets314
8Bromhexine Hydrochloride Injection228
9Glucosamine Sulfate Capsules2251
10维生素B6注射液 · No verified English name2210

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

325 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Guizhou Ke Lun Pharma Co., Ltd. romanized931
2Janssen-Cilag International NV750
3Bristol-Myers Squibb Pharma EEIG730
4Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.710
5Bard Pharmaceuticals Limited660
6Jiangsu Shen Hua Pharma Co., Ltd. romanized550
7AstraZeneca AB540
8Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized530
9Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized520
10Shanxi Hua Kang Pharma Co., Ltd. romanized440

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

169 this week

AcceptedDrugApplicants
2024/10/16Generic · Class 3 Alendronate Sodium Oral SolutionCYHS2403492 Hainan Si Da Pharmaceutical Co., Ltd. romanized
2024/10/16Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2403488 Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized
2024/10/16Generic · Class 3 Mesalazine Gastro-Resistant Prolonged-Release GranulesCYHS2403486 Beijing Foyou Pharma CO.,LTD
2024/10/16Generic · Class 3 Mesalazine Gastro-Resistant Prolonged-Release GranulesCYHS2403485 Beijing Foyou Pharma CO.,LTD
2024/10/16Generic · Class 3 Bromhexine Hydrochloride InjectionCYHS2403484 Yi Ling Wan Zhou International Pharmaceutical Co., Ltd. romanized; Jewim Pharmaceutical (Shandong) Co., Ltd.
2024/10/16Generic · Class 3 Hydrocortisone Sodium Succinate for InjectionCYHS2403482 Hainan Zi Cheng Zhong Tou Bio Technology Co., Ltd. romanized; Liaoning Hai Si Ke Pharmaceutical Co., Ltd. romanized
2024/10/16Generic · Class 3 利多卡因丙胺卡因气雾剂 · No verified English nameCYHL2400201 Jiangxi Hui Ren Pharma Co., Ltd. romanized
2024/10/16New drug · Class 3.3 冻干人用狂犬病疫苗(人二倍体细胞) · No verified English nameCXSS2400112 Anhui Zhi Fei Long Ke Ma Biopharmaceutical Co., Ltd. romanized
2024/10/16New drug · Class 1 IBI3005 · No verified English nameCXSL2400699 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2024/10/16New drug · Class 1 RGB-5088胰岛细胞注射液 · No verified English nameCXSL2400698 Hangzhou Rui Pu Chen Chuang Technology Co., Ltd. romanized
2024/10/16New drug · Class 1 CM559注射液 · No verified English nameCXSL2400697 Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized
2024/10/16New drug · Class 1 SHR-1819注射液 · No verified English nameCXSL2400696 Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/10/16New drug · Class 1 HDM1005注射液 · No verified English nameCXHL2401093 Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized
2024/10/16New drug · Class 1 HDM1005注射液 · No verified English nameCXHL2401092 Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized
2024/10/16New drug · Class 2.2 SXF-100 · No verified English nameCXHL2401091 Shanghai Xin Feng Pharmaceutical Co., Ltd. romanized
2024/10/16New drug · Class 2.3 奥美沙坦酯左氨氯地平片 · No verified English nameCXHL2401090 Beijing Foyou Pharma CO.,LTD
2024/10/16New drug · Class 1 PZH2109胶囊 · No verified English nameCXHL2401089 Zhang Zhou Pian Zai Huang Pharma Co., Ltd. romanized
2024/10/16New drug · Class 1 PZH2109胶囊 · No verified English nameCXHL2401088 Zhang Zhou Pian Zai Huang Pharma Co., Ltd. romanized
2024/10/16New drug · Class 1 PZH2109胶囊 · No verified English nameCXHL2401087 Zhang Zhou Pian Zai Huang Pharma Co., Ltd. romanized
2024/10/16New drug · Class 1 HJ787软膏 · No verified English nameCXHL2401086 Chengdu Hua Jian Wei Lai Technology Co., Ltd. romanized
2024/10/16New drug · Class 1 HJ787软膏 · No verified English nameCXHL2401085 Chengdu Hua Jian Wei Lai Technology Co., Ltd. romanized
2024/10/16New drug · Class 1 TollB-001片 · No verified English nameCXHL2401084 Beijing Tuo Ling Bo Tai Bio Technology Co., Ltd. romanized
2024/10/16New drug · Class 1 TollB-001片 · No verified English nameCXHL2401083 Beijing Tuo Ling Bo Tai Bio Technology Co., Ltd. romanized
2024/10/16New drug · Class 1 PD-DP-008凝胶 · No verified English nameCXHL2401082 Chengdu Pei De Biopharmaceuticals Co., Ltd. romanized
2024/10/15Import · Class 1 Aficamten片 · No verified English nameJXHS2400085 Cytokinetics Incorporated; Patheon Inc.; Sanofi (China) Investment Co. Ltd.
2024/10/15Import · Class 1 Bepirovirsen 注射液 · No verified English nameJXHL2400246 GlaxoSmithKline Trading Services Limited; GlaxoSmithKline (China) Investment Company Limited
2024/10/15Import · Class 1 Daplusiran/Tomligisiran 注射液 · No verified English nameJXHL2400245 GlaxoSmithKline Trading Services Limited; GlaxoSmithKline (China) Investment Company Limited
2024/10/15Generic · Class 3 Hydrocortisone Sodium Succinate for InjectionCYHS2403475 Chongqing Wan Lin Biopharmaceuticals Technology Co., Ltd. romanized; Chongqing Lai Mei Pharma Co., Ltd. romanized
2024/10/15Generic · Class 3 Hydrocortisone Sodium Succinate for InjectionCYHS2403474 Chongqing Wan Lin Biopharmaceuticals Technology Co., Ltd. romanized; Chongqing Lai Mei Pharma Co., Ltd. romanized
2024/10/15Generic · Class 3 聚乙二醇3350散 · No verified English nameCYHS2403471 Ma Ying Long Pharma Group Co., Ltd. romanized

139 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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