YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 331 drug applications between 18 September 2023 and 24 September 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 87, covering 74 drug names.

2023/09/18 – 2023/09/24

Period
2023/09/18 to 2023/09/24, 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
331
Drugs with new generic filings (by drug name, de-duplicated)
74
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

331filings, 87 of them generic

By application type

Application typeFilings
Supplement161
Generic87
New drug50
Import27
Unspecified3
Import re-registration3

By drug type

Drug typeFilings
Chemical drug245
TCM49
Therapeutic biologic30
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

74 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
6Digoxin Injection213
7Celecoxib Tablets213
8Oxcarbazepine Tablets214
9生理氯化钠溶液 · No verified English name2117
10Dopamine Hydrochloride Injection213

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

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

104 this week

AcceptedDrugApplicants
2023/09/23Generic · Class 3 Amlodipine Besylate and Benazepril Hydrochloride CapsulesCYHS2302581 Di Ao Group Chengdu Pharma Co., Ltd. romanized
2023/09/23Generic · Class 3 Magnesium Sulfate InjectionCYHS2302580 Yunnan Yao Ke Yuan Biopharmaceuticals Co., Ltd. romanized; Chu Xiong He Chuang Pharma Co., Ltd. romanized
2023/09/23Generic · Class 3 Betamethasone Sodium Phosphate InjectionCYHS2302577 CISEN PHARMACEUTICAL CO., LTD.
2023/09/23Generic · Class 3 奥美拉唑碳酸氢钠胶囊(Ⅱ) · No verified English nameCYHS2302576 Ningbo Menovo Tiankang Pharmaceutical Co., Ltd.
2023/09/23Generic · Class 3 Omeprazole and Sodium Bicarbonate CapsulesCYHS2302575 Ningbo Menovo Tiankang Pharmaceutical Co., Ltd.
2023/09/23Generic · Class 3 Digoxin InjectionCYHS2302574 Anhui Chang Jiang Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/09/23Generic · Class 3 Digoxin InjectionCYHS2302573 Anhui Chang Jiang Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/09/23New drug · Class 1 Xs02注射液 · No verified English nameCXSL2300649 Beijing Xian Sheng Xiang Rui Bio Zhi Pin Co., Ltd. romanized
2023/09/23New drug · Class 1 Xs02注射液 · No verified English nameCXSL2300648 Beijing Xian Sheng Xiang Rui Bio Zhi Pin Co., Ltd. romanized
2023/09/23New drug · Class 1 Xs02注射液 · No verified English nameCXSL2300647 Beijing Xian Sheng Xiang Rui Bio Zhi Pin Co., Ltd. romanized
2023/09/23New drug · Class 2.2 SHR-8068注射液 · No verified English nameCXSL2300646 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2023/09/23New drug · Class 1 BPAb002注射液 · No verified English nameCXSL2300645 Bo Pin Ze Rong (Shenzhen) Biopharmaceuticals Technology Co., Ltd. romanized
2023/09/23New drug · Class 1 斯美瑞非片 · No verified English nameCXHS2300087 Suzhou Wang Shan Wang Shui Biopharmaceuticals Co., Ltd. romanized; Suzhou Te Rui Pharma Co., Ltd. romanized
2023/09/23New drug · Class 1 斯美瑞非片 · No verified English nameCXHS2300086 Suzhou Wang Shan Wang Shui Biopharmaceuticals Co., Ltd. romanized; Suzhou Te Rui Pharma Co., Ltd. romanized
2023/09/23New drug · Class 1 斯美瑞非片 · No verified English nameCXHS2300085 Suzhou Wang Shan Wang Shui Biopharmaceuticals Co., Ltd. romanized; Suzhou Te Rui Pharma Co., Ltd. romanized
2023/09/23New drug · Class 1 KC1036片 · No verified English nameCXHL2301030 Beijing Kang Chen Pharma Co., Ltd. romanized
2023/09/23New drug · Class 1 KC1036片 · No verified English nameCXHL2301029 Beijing Kang Chen Pharma Co., Ltd. romanized
2023/09/23New drug · Class 2.1; 2.2; 2.4 盐酸(R)氯胺酮鼻用喷雾剂 · No verified English nameCXHL2301028 Jiangsu En Hua Pharma Co., Ltd. romanized
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

74 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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