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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 255 drug applications between 6 June 2023 and 12 June 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 69, covering 46 drug names.

2023/06/06 – 2023/06/12

Period
2023/06/06 to 2023/06/12, 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
255
Drugs with new generic filings (by drug name, de-duplicated)
46
Accepted this week, now under review
0

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

255filings, 69 of them generic

By application type

Application typeFilings
Supplement104
Generic69
New drug53
Import13
Unspecified11
Import re-registration5

By drug type

Drug typeFilings
Chemical drug181
Therapeutic biologic40
TCM26
Biologic4
Prophylactic 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

46 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Potassium Chloride Injection3310
2Minoxidil Topical Solution320
3Lactulose Oral Solution3134
4注射用头孢哌酮钠舒巴坦钠(2:1) · No verified English name312
5Neostigmine Methylsulfate Injection314
6Nitroglycerin Sublingual Tablets313
7Phloroglucinol Injection222
8Procaterol Hydrochloride Solution for Inhalation212
9地氯雷他定口服溶液 · No verified English name2126
10Potassium Chloride Granules214

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

165 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized610
2Dong Guan Shi Yang Zhi Kang Pharmaceuticals Co., Ltd. romanized440
3Xin Dong Sheng Ji Co., Ltd. romanized410
4Anhui Jiu Zhou Fang Yuan Pharmaceutical Co., Ltd. romanized330
5Guangxi Tai Nuo Pharmaceutical Co., Ltd. romanized330
6AstraZeneca AB320
7Merck Healthcare KGaA320
8Jiangsu En Hua Pharma Co., Ltd. romanized320
9Jiangxi Ke Rui Pharma Co., Ltd. romanized320
10Qilu Pharmaceutical Co., Ltd.320

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

93 this week

AcceptedDrugApplicants
2023/06/12New drug · Class 1.3 冻干人用CpG佐剂狂犬病疫苗(Vero细胞) · No verified English nameCXSL2300409 Changchun Zhuo Yi Bio Co., Ltd. romanized
2023/06/12New drug · Class 2.2; 2.4 注射用醋酸丙氨瑞林微球 · No verified English nameCXHL2300637 Shanghai Li Zhu Pharmaceutical Co., Ltd. romanized
2023/06/10Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2301598 Sheng Jia (Bin Hai) Biopharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/06/10Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2301597 Sheng Jia (Bin Hai) Biopharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/06/10Generic · Class 3 Potassium Chloride InjectionCYHS2301596 Chengdu Mi Zi Biopharmaceuticals Technology Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2023/06/10Generic · Class 3 Perospirone Hydrochloride TabletsCYHS2301594 Sichuan Ke Rui De Pharmaceutical Co., Ltd. romanized
2023/06/10Generic · Class 3 Perospirone Hydrochloride TabletsCYHS2301593 Sichuan Ke Rui De Pharmaceutical Co., Ltd. romanized
2023/06/10Generic · Class 3 Nitroglycerin InjectionCYHS2301592 Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2023/06/10Generic · Class 3 Nitroglycerin InjectionCYHS2301591 Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2023/06/10Generic · Class 3 Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2301590 Qilu Pharmaceutical (Hainan) Co., Ltd
2023/06/10Generic · Class 3 Potassium Chloride GranulesCYHS2301588 Ji Chuan Pharma Group Co., Ltd. romanized
2023/06/10Generic · Class 3 Potassium Chloride GranulesCYHS2301587 Ji Chuan Pharma Group Co., Ltd. romanized
2023/06/10Generic · Class 3 Bumetanide InjectionCYHS2301586 Chengdu Easton Biopharmaceuticals Co.,Ltd.
2023/06/10Generic · Class 3 Nicergoline TabletsCYHS2301585 Beijing Jiu Neng Tian Yuan Technology Co., Ltd. romanized; Shandong Qidu Pharmaceutical Co., Ltd.
2023/06/10New drug · Class 1 TAVO412注射液 · No verified English nameCXSL2300408 Tuo Chuang Bio Technology (Jiangsu) Co., Ltd. romanized
2023/06/10New drug · Class 1.2 人用狂犬病mRNA疫苗 · No verified English nameCXSL2300407 Zhuhai Li Fan Da Bio Technology Co., Ltd. romanized; Ai Mei Yi Miao Co., Ltd. romanized
2023/06/10New drug · Class 1 SGN1注射液 · No verified English nameCXSL2300406 Guangzhou Hua Jin Pharmaceuticals Technology Co., Ltd. romanized
2023/06/10New drug · Class 1 SGN1注射液 · No verified English nameCXSL2300405 Guangzhou Hua Jin Pharmaceuticals Technology Co., Ltd. romanized
2023/06/10New drug · Class 1 SM17单克隆抗体注射液 · No verified English nameCXSL2300404 Xing Lian Pharma (Suzhou) Co., Ltd. romanized
2023/06/10New drug · Class 1 ZX-7101A片 · No verified English nameCXHL2300636 Nanjing Zheng Xiang Pharmaceuticals Co., Ltd. romanized
2023/06/10New drug · Class 1 ZX-7101A片 · No verified English nameCXHL2300635 Nanjing Zheng Xiang Pharmaceuticals Co., Ltd. romanized
2023/06/10New drug · Class 2.4; 2.1 ASC10片 · No verified English nameCXHL2300634 Ge Li Bio Technology (Hangzhou) Co., Ltd. romanized
2023/06/10New drug · Class 1 HRS-7450注射液 · No verified English nameCXHL2300633 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized
2023/06/10New drug · Class 1 PG-011凝胶(Ⅱ) · No verified English nameCXHL2300632 Beijing Pu Qi Pharmaceuticals Technology Co., Ltd. romanized
2023/06/10New drug · Class 1 PG-011凝胶(Ⅱ) · No verified English nameCXHL2300631 Beijing Pu Qi Pharmaceuticals Technology Co., Ltd. romanized
2023/06/10New drug · Class 1 ISM4808胶囊 · No verified English nameCXHL2300630 Ying Xi Zhi Neng Technology (Shanghai) Co., Ltd. romanized
2023/06/10New drug · Class 1 ISM4808胶囊 · No verified English nameCXHL2300629 Ying Xi Zhi Neng Technology (Shanghai) Co., Ltd. romanized
2023/06/10New drug · Class 2.3 HMK-JST-080 · No verified English nameCXHL2300628 Zhejiang He Mu Kang Pharmaceuticals Technology Co., Ltd. romanized
2023/06/10New drug · Class 1 APL-1401胶囊 · No verified English nameCXHL2300627 Jiangsu Ya Hong Pharmaceuticals Technology Co., Ltd. romanized
2023/06/10New drug · Class 1 APL-1401胶囊 · No verified English nameCXHL2300626 Jiangsu Ya Hong Pharmaceuticals Technology Co., Ltd. romanized

63 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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