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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 311 drug applications between 17 April 2024 and 23 April 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 95, covering 71 drug names.

2024/04/17 – 2024/04/23

Period
2024/04/17 to 2024/04/23, 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
311
Drugs with new generic filings (by drug name, de-duplicated)
71
Accepted this week, now under review
2

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

311filings, 95 of them generic

By application type

Application typeFilings
Supplement131
Generic95
New drug59
Import16
Unspecified8
Import re-registration2

By drug type

Drug typeFilings
Chemical drug201
TCM52
Therapeutic biologic50
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

71 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ambroxol Hydrochloride Solution For Inhalation4210
2地氯雷他定口服溶液 · No verified English name3226
3二甲硅油乳剂 · No verified English name3114
4Palbociclib Capsules310
5Pamidronate Disodium Injection312
6Paliperidone Palmitate Injection318
7Aripiprazole Oral Solution314
8Pranoprofen Eye Drops227
9Metoclopramide Hydrochloride Injection226
10Glucosamine Sulfate Capsules2251

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

199 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Chen Huan Pharmaceuticals Group Co., Ltd. romanized990
2Bristol-Myers Squibb Pharma EEIG930
3Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized740
4Hua Jin (Chongqing) Pharma Co., Ltd. romanized610
5Heilongjiang Song Ci Pharmaceutical Co., Ltd. romanized540
6Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.523
7Qinghai Jiu Mei Zang Yao Pharma Co., Ltd. romanized440
8Nanjing Hai Na Pharmaceutical Co., Ltd. romanized434
9Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized430
10Beijing Ya Dong Biopharmaceutical 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

114 this week

AcceptedDrugApplicants
2024/04/23Import · Class 1 注射用ASP5354 · No verified English nameJXHL2400095 Astellas Pharma Global Development Inc.; Astellas (China) Investment Co. Ltd.
2024/04/23Generic · Class 3 Ambroxol Hydrochloride Solution For InhalationCYHS2401222 Sichuan Pu Rui Te Pharma Co., Ltd. romanized
2024/04/23Generic · Class 3 Ambroxol Hydrochloride Solution For InhalationCYHS2401221 Sichuan Pu Rui Te Pharma Co., Ltd. romanized
2024/04/23Generic · Class 3 Ambroxol Hydrochloride Solution For InhalationCYHS2401220 Sichuan Pu Rui Te Pharma Co., Ltd. romanized
2024/04/23Generic · Class 3 碳酸氢钠血滤置换液(钾4mmol/L无钙) · No verified English nameCYHS2401218 Shanghai Feng Lin Bio Technology Co., Ltd. romanized; Shanghai Chang Zheng Fu Min Jin Shan Pharmaceutical Co., Ltd. romanized
2024/04/23Generic · Class 3 Potassium Phosphates InjectionCYHS2401217 Jia Heng (Zhuhai Heng Qin) Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2024/04/23Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2401215 Shu Mei Qi Chengdu Bio Technology Co., Ltd. romanized; Chengdu Tong De Pharma Co., Ltd. romanized
2024/04/23Generic · Class 3 德昔度司他片 · No verified English nameCYHS2401213 Kang Zhe (Hunan) Pharmaceutical Co., Ltd. romanized
2024/04/23Generic · Class 3 甲氧氯普胺片 · No verified English nameCYHS2401212 Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/04/23Generic · Class 3 甲氧氯普胺片 · No verified English nameCYHS2401211 Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/04/23Generic · Class 3 眼用丝裂霉素溶液用粉末 · No verified English nameCYHS2401210 Zhejiang Zhang Dian Drug Technology Kai Fa Co., Ltd. romanized; Zhejiang Hai Zheng Pharma Co., Ltd. romanized
2024/04/23Generic · Class 3 Roxatidine Acetate Hydrochloride For InjectionCYHS2401209 Anhui Pioneer Pharmaceutical Co., Ltd
2024/04/23Generic · Class 3 Tirofiban Hydrochloride And Sodium Chloride InjectionCYHS2401208 Anhui Shuang He Pharma Co., Ltd. romanized
2024/04/23Generic · Class 3 Acetylcysteine InjectionCYHS2401207 Suzhou Hong Sen Pharma Co., Ltd. romanized
2024/04/23Generic · Class 3 Tirofiban Hydrochloride And Sodium Chloride InjectionCYHS2401206 Anhui Shuang He Pharma Co., Ltd. romanized
2024/04/23Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2401202 Wan Te Pharmaceutical (Hainan) Co., Ltd. romanized
2024/04/23New drug · Class 1 人羊膜间充质干细胞注射液 · No verified English nameCXSL2400258 Yuan Pin Xi Bao Bio Technology Group Co., Ltd. romanized
2024/04/23New drug · Class 1.2 冻干b型流感嗜血杆菌结合疫苗 · No verified English nameCXSL2400257 Yuan Da Sai Wei Xin Sheng Ming Ke Xue (Nanjing) Co., Ltd. romanized; Yuan Da Sai Wei Xin Sheng Ming Ke Xue (Hangzhou) Co., Ltd. romanized
2024/04/23New drug · Class 1 MRG006A · No verified English nameCXSL2400256 Le Pu Bio Technology Co., Ltd. romanized
2024/04/23New drug · Class 1 BC008-1A注射液 · No verified English nameCXSL2400255 Sichuan Lu Zhou Bu Zhang Biopharmaceutical Co., Ltd. romanized
2024/04/23New drug · Class 2.4 氟唑帕利胶囊 · No verified English nameCXHS2400032 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/04/23New drug · Class 2.4 Apatinib Mesylate TabletsCXHS2400031 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/04/23New drug · Class 2.4 Apatinib Mesylate TabletsCXHS2400030 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/04/23New drug · Class 2.4 甲磺酸伏美替尼片 · No verified English nameCXHL2400411 Shanghai Ai Li Si Pharmaceuticals Technology Co., Ltd. romanized
2024/04/23New drug · Class 2.4 羟乙磺酸达尔西利片 · No verified English nameCXHL2400410 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/04/23New drug · Class 2.4 羟乙磺酸达尔西利片 · No verified English nameCXHL2400409 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/04/23New drug · Class 2.4 羟乙磺酸达尔西利片 · No verified English nameCXHL2400408 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
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

84 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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