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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 355 drug applications between 15 September 2023 and 21 September 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 72, covering 59 drug names.

2023/09/15 – 2023/09/21

Period
2023/09/15 to 2023/09/21, 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
355
Drugs with new generic filings (by drug name, de-duplicated)
59
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

355filings, 72 of them generic

By application type

Application typeFilings
Supplement203
Generic72
New drug45
Import20
Import re-registration9
Unspecified6

By drug type

Drug typeFilings
Chemical drug244
TCM72
Therapeutic biologic34
Prophylactic biologic5

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

59 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Sodium Valproate Sustained-release Tablets(I)224
2Diprophylline Injection227
3Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution2223
4Tacrolimus Ointment216
5Celecoxib Tablets213
6Oxcarbazepine Tablets214
7Omeprazole and Sodium Bicarbonate Capsules210
8Sacubitril Valsartan Sodium Tablets2170
9Famotidine Injection218
10生理氯化钠溶液 · No verified English name2117

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

203 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Henan Yue Ren Pharma Co., Ltd. romanized12120
2Henan Shuang He Hua Li Pharma Co., Ltd. romanized1230
3Boehringer Ingelheim International GmbH710
4Bard Pharmaceuticals Limited660
5AstraZeneca AB640
6Hebei Wan Bang Fu Lin Pharma Co., Ltd. romanized550
7HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.520
8Shaanxi Li Cai Pharma Co., Ltd. romanized522
9Shanghai Pharmaceuticals Group Qingdao Guo Feng Pharma Co., Ltd. romanized440
10Guangxi Shi Wan Shan Pharmaceutical 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

89 this week

AcceptedDrugApplicants
2023/09/21Import · Class 2.4 Osimertinib Mesylate TabletsJXHS2300087 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2023/09/21Import · Class 2.4 Osimertinib Mesylate TabletsJXHS2300086 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2023/09/21Generic · Class 3 草酸艾司西酞普兰口服溶液 · No verified English nameCYHS2302553 Beijing Hai Bu Pharmaceuticals Technology Co., Ltd. romanized; Tian Da Pharma (Zhuhai) Co., Ltd. romanized
2023/09/21Generic · Class 3 Methocarbamol InjectionCYHS2302547 ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.
2023/09/21Generic · Class 3 Epalrestat TabletsCYHS2302544 Zhongshan Wanhan Pharmaceuticals Co., Ltd.
2023/09/21Generic · Class 3 生理氯化钠溶液 · No verified English nameCYHS2302543 Shandong Ke Lun Pharma Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd.
2023/09/21Generic · Class 3 生理氯化钠溶液 · No verified English nameCYHS2302542 Shandong Ke Lun Pharma Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd.
2023/09/21Generic · Class 3 阿瑞匹坦注射液 · No verified English nameCYHL2300122 Qilu Pharmaceutical (Hainan) Co., Ltd
2023/09/21New drug · Class 1.1 比那甫西颗粒 · No verified English nameCXZS2300019 Xinjiang Yin Duo Lan Pharma Co., Ltd. romanized
2023/09/21New drug · Class 1 注射用AP026 · No verified English nameCXSL2300640 An Yuan Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2023/09/21New drug · Class 2.4 注射用重组人凝血因子Ⅷ-Fc融合蛋白 · No verified English nameCXSL2300639 Chengdu Rong Sheng Pharma Co., Ltd. romanized
2023/09/21New drug · Class 2.4 注射用重组人凝血因子Ⅷ-Fc融合蛋白 · No verified English nameCXSL2300638 Chengdu Rong Sheng Pharma Co., Ltd. romanized
2023/09/21New drug · Class 1 HG153片 · No verified English nameCXHL2301023 Chengdu Xian Dao Drug Kai Fa Co., Ltd. romanized
2023/09/21New drug · Class 1 HG153片 · No verified English nameCXHL2301022 Chengdu Xian Dao Drug Kai Fa Co., Ltd. romanized
2023/09/20Generic · Class 3 醋酸钠林格葡萄糖注射液 · No verified English nameCYHS2302536 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2023/09/20Generic · Class 3 羧甲司坦糖浆 · No verified English nameCYHS2302535 Anhui Mao Kang Pharma Co., Ltd. romanized; Hua Yi Pharma Technology (Anhui) Co., Ltd. romanized
2023/09/20Generic · Class 3 羧甲司坦糖浆 · No verified English nameCYHS2302534 Anhui Mao Kang Pharma Co., Ltd. romanized; Hua Yi Pharma Technology (Anhui) Co., Ltd. romanized
2023/09/20Generic · Class 3 Acetylcysteine InjectionCYHS2302530 Shu Mei Qi Chengdu Bio Technology Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized
2023/09/20Generic · Class 3 硝唑尼特干混悬剂 · No verified English nameCYHL2300121 Rui Yang Pharmaceutical Co., Ltd. romanized
2023/09/20Generic · Class 3 Glycopyrronium Bromide and Neostigmine Metilsulfate InjectionCYHL2300120 Zhejiang Feng Hua Pharmaceuticals Technology Co., Ltd. romanized
2023/09/20New drug · Class 2.2 连花清咳颗粒 · No verified English nameCXZL2300062 Shijiazhuang Yi Ling Pharma Co., Ltd. romanized
2023/09/20New drug · Class 1 注射用人脐带间充质干细胞 · No verified English nameCXSL2300637 Ai Er Pu Zai Sheng Yi Xue Technology (Shenzhen) Co., Ltd. romanized
2023/09/20New drug · Class 1 注射用RB0021 · No verified English nameCXSL2300636 Rui Yang (Suzhou) Bio Technology Co., Ltd. romanized
2023/09/20New drug · Class 1 GZR18片 · No verified English nameCXSL2300635 Gan Li Pharma Shandong Co., Ltd. romanized
2023/09/20New drug · Class 1 GZR18片 · No verified English nameCXSL2300634 Gan Li Pharma Shandong Co., Ltd. romanized
2023/09/20New drug · Class 1 GZR18片 · No verified English nameCXSL2300633 Gan Li Pharma Shandong Co., Ltd. romanized
2023/09/20New drug · Class 2.3 SMF-216 · No verified English nameCXHL2301021 Jiangxi Shimei Pharmaceutical Co., Ltd
2023/09/20New drug · Class 1 BGB-26808片 · No verified English nameCXHL2301020 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2023/09/20New drug · Class 1 BGB-26808片 · No verified English nameCXHL2301019 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2023/09/20New drug · Class 1 BGB-26808片 · No verified English nameCXHL2301018 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized

59 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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