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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 309 drug applications between 16 April 2024 and 22 April 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 89, covering 69 drug names.

2024/04/16 – 2024/04/22

Period
2024/04/16 to 2024/04/22, 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
309
Drugs with new generic filings (by drug name, de-duplicated)
69
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

309filings, 89 of them generic

By application type

Application typeFilings
Supplement128
Generic89
New drug62
Import18
Unspecified9
Import re-registration3

By drug type

Drug typeFilings
Chemical drug191
TCM61
Therapeutic biologic49
Prophylactic biologic5
Biologic3

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

69 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1二甲硅油乳剂 · No verified English name3114
2Palbociclib Capsules310
3Pamidronate Disodium Injection312
4Paliperidone Palmitate Injection318
5Aripiprazole Oral Solution314
6Pranoprofen Eye Drops227
7Metoclopramide Hydrochloride Injection226
8Glucosamine Sulfate Capsules2251
9地氯雷他定口服溶液 · No verified English name2126
10复方聚乙二醇电解质散(II) · No verified English name212

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

204 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hubei Yan Huang Ben Cao Pharma Co., Ltd. romanized880
2Chen Huan Pharmaceuticals Group Co., Ltd. romanized660
3Hua Jin (Chongqing) Pharma Co., Ltd. romanized610
4Heilongjiang Song Ci Pharmaceutical Co., Ltd. romanized540
5Shandong Xin Shi Dai Pharma Co., Ltd. romanized525
6Qinghai Jiu Mei Zang Yao Pharma Co., Ltd. romanized440
7Nanjing Hai Na Pharmaceutical Co., Ltd. romanized434
8Bristol-Myers Squibb Pharma EEIG420
9Beijing Ya Dong Biopharmaceutical Co., Ltd. romanized420
10Changchun Jin Sai Pharma Co., Ltd. romanized420

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

109 this week

AcceptedDrugApplicants
2024/04/22Generic · Class 3 Bupivacaine Hydrochloride InjectionCYHS2401201 Guangdong Ding Xin Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2024/04/22Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2401200 Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized; Le Sheng Pharma Shijiazhuang Co., Ltd. romanized
2024/04/22Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2401199 Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized; Le Sheng Pharma Shijiazhuang Co., Ltd. romanized
2024/04/22Generic · Class 3 Benazepril Hydrochloride and Hydrochlorothiazide TabletsCYHS2401197 Wei Sheng Yuan (Xiamen) Bio Technology Co., Ltd. romanized; Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized
2024/04/22Generic · Class 3 Ambroxol Hydrochloride Solution For InhalationCYHS2401191 Beijing Han Mei Medicines Co., Ltd. romanized
2024/04/22New drug · Class 2.2 TRD303溶液 · No verified English nameCXHL2400407 Beijing Tai De Pharmaceutical Co., Ltd. romanized
2024/04/20Import · Class 2.2 Anifrolumab注射液 · No verified English nameJXSL2400078 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd
2024/04/20Generic · Class 3 Betamethasone Sodium Phosphate InjectionCYHS2401190 Ta He Shi Hui Chuang Pharmaceuticals Co., Ltd. romanized; Yu Song Yuan Pharma Co., Ltd. romanized
2024/04/20New drug · Class 1.1 珍珠滴丸 · No verified English nameCXZS2400012 Guizhou Min Zu Pharma Co., Ltd. romanized
2024/04/20New drug · Class 1 KY-0118注射剂 · No verified English nameCXSL2400254 Ke Yi (Zhejiang) Pharma Technology Co., Ltd. romanized
2024/04/20New drug · Class 1 注射用BGB-B2033 · No verified English nameCXSL2400253 Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized
2024/04/20New drug · Class 1 EX101注射液 · No verified English nameCXSL2400252 Guangzhou Ai Si Mai Biopharmaceuticals Technology Co., Ltd. romanized
2024/04/20New drug · Class 2.2 信迪利单抗注射液 · No verified English nameCXSL2400251 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2024/04/20New drug · Class 1 WSD0922-FU片 · No verified English nameCXHL2400406 Wei Shang (Shanghai) Biopharmaceuticals Co., Ltd. romanized
2024/04/20New drug · Class 1 WSD0922-FU片 · No verified English nameCXHL2400405 Wei Shang (Shanghai) Biopharmaceuticals Co., Ltd. romanized
2024/04/20New drug · Class 1 WSD0922-FU片 · No verified English nameCXHL2400404 Wei Shang (Shanghai) Biopharmaceuticals Co., Ltd. romanized
2024/04/19Import · Class 1 Axatilimab注射液 · No verified English nameJXSL2400077 Incyte Corporation; Incyte Biosciences Shanghai Co. Ltd.
2024/04/19Generic · Class 3 Ebastine Oral SolutionCYHS2401178 Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2024/04/19Generic · Class 3 Clonazepam InjectionCYHS2401176 Guo Yao Group Guo Rui Pharma Co., Ltd. romanized
2024/04/19Generic · Class 3 Diprophylline InjectionCYHS2401173 Sichuan Tian Xing Hui Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized
2024/04/19Generic · Class 3 Metoclopramide Hydrochloride InjectionCYHS2401171 Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized
2024/04/19Generic · Class 3 Metoclopramide Hydrochloride InjectionCYHS2401169 Beijing Bai Ya Joint Drug Research Institute Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2024/04/19New drug · Class 1 VPD/FC01008 注射液 · No verified English nameCXSL2400250 Wei Neng Sheng Ming Technology Group Co., Ltd. romanized
2024/04/19New drug · Class 1 重组人源抗破伤风毒素单克隆抗体注射液 · No verified English nameCXSL2400249 Lanzhou Bio Zhi Pin Research Institute Co., Ltd. romanized
2024/04/19New drug · Class 3.3 流感病毒裂解疫苗 · No verified English nameCXSL2400248 Wuhan Bio Zhi Pin Research Institute Co., Ltd. romanized
2024/04/19New drug · Class 3.3 流感病毒裂解疫苗 · No verified English nameCXSL2400247 Wuhan Bio Zhi Pin Research Institute Co., Ltd. romanized
2024/04/19New drug · Class 2.2 盐酸普萘洛尔滴剂 · No verified English nameCXHS2400029 Sichuan Ao Bang Gu De Pharma Co., Ltd. romanized; Chengdu Li Er Pharma Co., Ltd. romanized
2024/04/19New drug · Class 1 FH-2001胶囊 · No verified English nameCXHL2400403 Jiangsu Xing Sheng Xin Hui Pharmaceuticals Co., Ltd. romanized
2024/04/19New drug · Class 2.4 林普利塞片 · No verified English nameCXHL2400402 Shanghai Ying Li Pharma Co., Ltd. romanized
2024/04/19New drug · Class 1 HRS-1358片 · No verified English nameCXHL2400401 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized

79 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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