YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 365 drug applications between 16 September 2023 and 22 September 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 82, covering 67 drug names.

2023/09/16 – 2023/09/22

Period
2023/09/16 to 2023/09/22, 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
365
Drugs with new generic filings (by drug name, de-duplicated)
67
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

365filings, 82 of them generic

By application type

Application typeFilings
Supplement200
Generic82
New drug44
Import28
Unspecified7
Import re-registration4

By drug type

Drug typeFilings
Chemical drug259
TCM72
Therapeutic biologic27
Prophylactic biologic5
Biologic2

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

67 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Tapentadol Hydrochloride Tablets310
2Sodium Valproate Sustained-release Tablets(I)224
3Diprophylline Injection227
4Methocarbamol Injection223
5Tacrolimus Ointment216
6Celecoxib Tablets213
7Oxcarbazepine Tablets214
8Omeprazole and Sodium Bicarbonate Capsules210
9Sacubitril Valsartan Sodium Tablets2170
10Famotidine Injection218

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

206 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Boehringer Ingelheim International GmbH1310
2Henan Yue Ren Pharma Co., Ltd. romanized12120
3Henan Shuang He Hua Li Pharma Co., Ltd. romanized1230
4Hebei Wan Bang Fu Lin Pharma Co., Ltd. romanized550
5Shanxi Huang He Zhong Yao Co., Ltd. romanized540
6Jiangxi Shimei Pharmaceutical Co., Ltd544
7HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.520
8Shaanxi Li Cai Pharma Co., Ltd. romanized522
9Bard Pharmaceuticals Limited440
10Novartis Europharm Limited420

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

97 this week

AcceptedDrugApplicants
2023/09/22Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2300244 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2023/09/22Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2300243 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2023/09/22Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2300242 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2023/09/22Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2300241 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2023/09/22Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2300240 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2023/09/22Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2300239 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2023/09/22Import · Class 1 CFT8919片 · No verified English nameJXHL2300238 C4 Therapeutics Inc.; Betta Pharmaceuticals Co. Ltd.
2023/09/22Import · Class 1 CFT8919片 · No verified English nameJXHL2300237 C4 Therapeutics Inc.; Betta Pharmaceuticals Co. Ltd.
2023/09/22Generic · Class 3 Tapentadol Hydrochloride TabletsCYHS2302569 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2023/09/22Generic · Class 3 Tapentadol Hydrochloride TabletsCYHS2302568 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2023/09/22Generic · Class 3 Tapentadol Hydrochloride TabletsCYHS2302567 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2023/09/22Generic · Class 3 盐酸拉贝洛尔氯化钠注射液 · No verified English nameCYHS2302560 Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized; Chi Feng Yuan Sheng Pharma Co., Ltd. romanized
2023/09/22Generic · Class 3 Methocarbamol InjectionCYHS2302559 Suzhou Te Rui Pharma Co., Ltd. romanized; Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized
2023/09/22New drug · Class 2.3 保妇康栓 · No verified English nameCXZL2300063 Hainan Bi Kai Pharma Co., Ltd. romanized
2023/09/22New drug · Class 1 WST04制剂(胶囊) · No verified English nameCXSL2300644 Shanghai Shang Yao Xin Yi Pharmaceutical Factory Co., Ltd. romanized
2023/09/22New drug · Class 1 IBR733细胞注射液 · No verified English nameCXSL2300643 Ying Bai Rui (Hangzhou) Biopharmaceuticals Co., Ltd. romanized
2023/09/22New drug · Class 1 HD003细胞 · No verified English nameCXSL2300642 Hua Dao (Shanghai) Biopharmaceuticals Co., Ltd. romanized
2023/09/22New drug · Class 3.4 人凝血酶原复合物 · No verified English nameCXSL2300641 Guo Yao Group Guizhou Xue Ye Zhi Pin Co., Ltd. romanized
2023/09/22New drug · Class 2.2 盐酸多奈哌齐口溶膜 · No verified English nameCXHS2300084 Li Pin Pharma (Xiamen) Co., Ltd. romanized; Xiamen Li Zhuo Pharma Co., Ltd. romanized
2023/09/22New drug · Class 2.2 盐酸多奈哌齐口溶膜 · No verified English nameCXHS2300083 Li Pin Pharma (Xiamen) Co., Ltd. romanized; Xiamen Li Zhuo Pharma Co., Ltd. romanized
2023/09/22New drug · Class 1 177Lu-LNC1004注射液 · No verified English nameCXHL2301027 Yan Tai Lan Na Cheng Bio Technology Co., Ltd. romanized
2023/09/22New drug · Class 1 SHR0302缓释片 · No verified English nameCXHL2301026 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/09/22New drug · Class 1 SHR0302缓释片 · No verified English nameCXHL2301025 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/09/22New drug · Class 2.2; 2.4 TAP-1502喷雾剂 · No verified English nameCXHL2301024 Shanghai Ze De Man Pharmaceuticals Technology Co., Ltd. romanized
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.

67 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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