YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 570 drug applications between 11 October 2024 and 17 October 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 167, covering 124 drug names.

2024/10/11 – 2024/10/17

Period
2024/10/11 to 2024/10/17, 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
570
Drugs with new generic filings (by drug name, de-duplicated)
124
Accepted this week, now under review
4

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

570filings, 167 of them generic

By application type

Application typeFilings
Supplement242
Generic167
New drug97
Import38
Import re-registration14
Unspecified12

By drug type

Drug typeFilings
Chemical drug394
TCM94
Therapeutic biologic73
Prophylactic biologic5
Biologic4

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

124 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Fusidic Acid Cream5215
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

351 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Janssen-Cilag International NV960
2Guizhou Ke Lun Pharma Co., Ltd. romanized931
3Bristol-Myers Squibb Pharma EEIG730
4Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.710
5Bard Pharmaceuticals Limited660
6AstraZeneca AB640
7Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized640
8Novo Nordisk A/S620
9Jiangsu Shen Hua Pharma Co., Ltd. romanized550
10Shijiazhuang No.4 Pharmaceutical Co., Ltd.543

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

184 this week

AcceptedDrugApplicants
2024/10/17Import · Class 3.1 注射用sotatercept · No verified English nameJXSS2400095 Merck Sharp & Dohme LLC; Patheon Italia S.p.A.; MSD R&D (China) Co. Ltd.
2024/10/17Import · Class 3.1 注射用sotatercept · No verified English nameJXSS2400094 Merck Sharp & Dohme LLC; Patheon Italia S.p.A.; MSD R&D (China) Co. Ltd.
2024/10/17Import · Class 1 注射用Budigalimab · No verified English nameJXSL2400195 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2024/10/17Import · Class 1 ABBV-400注射用粉末 · No verified English nameJXSL2400194 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2024/10/17Generic · Class 3 维生素B??注射液 · No verified English nameThe loaded source record contains a question mark in this drug name; the original character has not been verified.CYHS2403517 Guangzhou Ren Heng Pharmaceuticals Technology Co., Ltd. romanized; Lang Tian Pharma (Hubei) Co., Ltd. romanized
2024/10/17Generic · Class 3 Metoclopramide Hydrochloride InjectionCYHS2403516 Yang Zhou Zhong Bao Pharma Co., Ltd. romanized
2024/10/17Generic · Class 3 Vigabatrin Powder for Oral SolutionCYHS2403515 Shanghai Shang Yao Xin Yi Pharmaceutical Factory Co., Ltd. romanized
2024/10/17Generic · Class 3 Venlafaxine Hydrochloride Extended Release TabletsCYHS2403508 Fu Xing Pharmaceuticals (Xu Zhou) Co., Ltd. romanized
2024/10/17Generic · Class 3 Levofloxacin InjectionCYHS2403507 YaoPharma Co., Ltd.
2024/10/17Generic · Class 3 Erythromycin Lactobionate for InjectionCYHS2403502 Guangdong Yue He Ze Drug Research Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2024/10/17Generic · Class 3 盐酸多沙普仑注射液 · No verified English nameCYHS2403501 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2024/10/17Generic · Class 3 Ferric Maltol CapsulesCYHL2400203 Hangzhou Qian Yuan Bao Ling Pharma Co., Ltd. romanized
2024/10/17Generic · Class 3 Relugolix TabletsCYHL2400202 Hangzhou Minsheng Pharmaceutical Co., Ltd
2024/10/17New drug · Class 1 注射用Zilovertamab vedotin · No verified English nameCXSL2400708 Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized
2024/10/17New drug · Class 1 注射用MK-6204(SKB535) · No verified English nameCXSL2400707 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2024/10/17New drug · Class 1 重组人源化抗表皮生长因子受体单克隆抗体注射液 · No verified English nameCXSL2400706 Shanghai Jin Man Te Bio Technology Co., Ltd. romanized
2024/10/17New drug · Class 1 重组红细胞生成刺激蛋白注射液(CHO细胞) · No verified English nameCXSL2400705 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized
2024/10/17New drug · Class 1 SYS6043 · No verified English nameCXSL2400704 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2024/10/17New drug · Class 1 RC1416注射液 · No verified English nameCXSL2400703 Nanjing Rong Jie Kang Bio Technology Co., Ltd. romanized
2024/10/17New drug · Class 1 RC1416注射液 · No verified English nameCXSL2400702 Nanjing Rong Jie Kang Bio Technology Co., Ltd. romanized
2024/10/17New drug · Class 1 CD-001注射液 · No verified English nameCXSL2400701 Cheng Dian (Suzhou) Biopharmaceuticals Co., Ltd. romanized
2024/10/17New drug · Class 1 注射用ZG005 · No verified English nameCXSL2400700 Name not romanized; Name not romanized
2024/10/17New drug · Class 2.2 BCM851口溶膜 · No verified English nameCXHL2401099 Shanghai Yun Cheng Yan Xin Bio Technology Co., Ltd. romanized
2024/10/17New drug · Class 2.2 BCM851口溶膜 · No verified English nameCXHL2401098 Shanghai Yun Cheng Yan Xin Bio Technology Co., Ltd. romanized
2024/10/17New drug · Class 2.2 BCM851口溶膜 · No verified English nameCXHL2401097 Shanghai Yun Cheng Yan Xin Bio Technology Co., Ltd. romanized
2024/10/17New drug · Class 2.2 BCM851口溶膜 · No verified English nameCXHL2401096 Shanghai Yun Cheng Yan Xin Bio Technology Co., Ltd. romanized
2024/10/17New drug · Class 1 H002胶囊 · No verified English nameCXHL2401095 Tai Zhou Hong Yun Pharmaceutical Co., Ltd. romanized
2024/10/17New drug · Class 1 盐酸吉卡昔替尼片 · No verified English nameCXHL2401094 Name not romanized; Name not romanized
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

154 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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