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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 243 drug applications between 4 March 2024 and 10 March 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 64, covering 49 drug names.

2024/03/04 – 2024/03/10

Period
2024/03/04 to 2024/03/10, 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
243
Drugs with new generic filings (by drug name, de-duplicated)
49
Accepted this week, now under review
1

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

243filings, 64 of them generic

By application type

Application typeFilings
Supplement112
Generic64
New drug34
Import23
Import re-registration7
Unspecified3

By drug type

Drug typeFilings
Chemical drug164
Therapeutic biologic44
TCM33
Biologic1
Prophylactic biologic1

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

49 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Brivaracetam Tablets3119
2Neostigmine Methylsulfate Injection314
3Glucosamine Sulfate Capsules2251
4Lactulose Oral Solution2134
5Tadalafil Tablets2123
6复方氨基酸(16)双肽(1)注射液 · No verified English name210
7Ozagrel Sodium Injection213
8Vonoprazan Fumarate Tablets2160
9帕立骨化醇软胶囊 · No verified English name210
10Vortioxetine Hydrobromide Tablets2110

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

148 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Sichuan Guang Da Pharmaceutical Co., Ltd. romanized1090
2Ascendis Pharma Endocrinology Division A/S910
3Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized810
4Kyowa Kirin Co. Ltd.510
5Shenyang San Sheng Pharmaceutical Co., Ltd. romanized510
6Shijiazhuang No.4 Pharmaceutical Co., Ltd.431
7Pfizer Inc.420
8Anhui Wei Er Man Pharmaceutical Co., Ltd. romanized420
9H. Lundbeck A/S410
10Takeda Manufacturing Austria AG410

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

84 this week

AcceptedDrugApplicants
2024/03/09New drug · Class 1 注射用MK-2870 · No verified English nameCXSL2400175 Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized
2024/03/09New drug · Class 1 EB160片 · No verified English nameCXHL2400263 Zhong Shan You Li Biopharmaceuticals Co., Ltd. romanized
2024/03/09New drug · Class 1 EB160片 · No verified English nameCXHL2400262 Zhong Shan You Li Biopharmaceuticals Co., Ltd. romanized
2024/03/09New drug · Class 1 EB160片 · No verified English nameCXHL2400261 Zhong Shan You Li Biopharmaceuticals Co., Ltd. romanized
2024/03/08Import · Class 3.1 注射用隆培促生长素 · No verified English nameJXSS2400025 Ascendis Pharma Endocrinology Division A/S; Vetter Pharma-Fertigung GmbH & Co. KG; VISEN Pharmaceuticals (Shanghai) Co. Ltd.
2024/03/08Import · Class 3.1 注射用隆培促生长素 · No verified English nameJXSS2400024 Ascendis Pharma Endocrinology Division A/S; Vetter Pharma-Fertigung GmbH & Co. KG; VISEN Pharmaceuticals (Shanghai) Co. Ltd.
2024/03/08Import · Class 3.1 注射用隆培促生长素 · No verified English nameJXSS2400023 Ascendis Pharma Endocrinology Division A/S; Vetter Pharma-Fertigung GmbH & Co. KG; VISEN Pharmaceuticals (Shanghai) Co. Ltd.
2024/03/08Import · Class 3.1 注射用隆培促生长素 · No verified English nameJXSS2400022 Ascendis Pharma Endocrinology Division A/S; Vetter Pharma-Fertigung GmbH & Co. KG; VISEN Pharmaceuticals (Shanghai) Co. Ltd.
2024/03/08Import · Class 3.1 注射用隆培促生长素 · No verified English nameJXSS2400021 Ascendis Pharma Endocrinology Division A/S; Vetter Pharma-Fertigung GmbH & Co. KG; VISEN Pharmaceuticals (Shanghai) Co. Ltd.
2024/03/08Import · Class 3.1 注射用隆培促生长素 · No verified English nameJXSS2400020 Ascendis Pharma Endocrinology Division A/S; Vetter Pharma-Fertigung GmbH & Co. KG; VISEN Pharmaceuticals (Shanghai) Co. Ltd.
2024/03/08Import · Class 3.1 注射用隆培促生长素 · No verified English nameJXSS2400019 Ascendis Pharma Endocrinology Division A/S; Vetter Pharma-Fertigung GmbH & Co. KG; VISEN Pharmaceuticals (Shanghai) Co. Ltd.
2024/03/08Import · Class 3.1 注射用隆培促生长素 · No verified English nameJXSS2400018 Ascendis Pharma Endocrinology Division A/S; Vetter Pharma-Fertigung GmbH & Co. KG; VISEN Pharmaceuticals (Shanghai) Co. Ltd.
2024/03/08Import · Class 3.1 注射用隆培促生长素 · No verified English nameJXSS2400017 Ascendis Pharma Endocrinology Division A/S; Vetter Pharma-Fertigung GmbH & Co. KG; VISEN Pharmaceuticals (Shanghai) Co. Ltd.
2024/03/08Import · Class 1.1 呼吸道合胞病毒减毒活疫苗 · No verified English nameJXSL2400058 Sanofi Pasteur Inc.; Shenzhen Sanofi Pasteur Biological Products Co. Ltd
2024/03/08Generic · Class 3 复方氨基酸(16)双肽(1)注射液 · No verified English nameCYHS2400802 Nei Menggu Bai Yi Pharmaceutical Co., Ltd. romanized
2024/03/08Generic · Class 3 复方氨基酸(16)双肽(1)注射液 · No verified English nameCYHS2400801 Nei Menggu Bai Yi Pharmaceutical Co., Ltd. romanized
2024/03/08New drug · Class 1 SPH7450片 · No verified English nameCXHL2400260 Shanghai Pharmaceuticals Group Co., Ltd. romanized
2024/03/08New drug · Class 1 SPH7450片 · No verified English nameCXHL2400259 Shanghai Pharmaceuticals Group Co., Ltd. romanized
2024/03/08New drug · Class 1 SPH7450片 · No verified English nameCXHL2400258 Shanghai Pharmaceuticals Group Co., Ltd. romanized
2024/03/08New drug · Class 1 SPH7450片 · No verified English nameCXHL2400257 Shanghai Pharmaceuticals Group Co., Ltd. romanized
2024/03/08New drug · Class 1 HRS9531片 · No verified English nameCXHL2400256 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized
2024/03/08New drug · Class 1 HRS9531片 · No verified English nameCXHL2400255 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized
2024/03/08New drug · Class 1 HRS9531片 · No verified English nameCXHL2400254 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized
2024/03/08New drug · Class 1 HRS9531片 · No verified English nameCXHL2400253 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized
2024/03/08New drug · Class 1 HRS9531片 · No verified English nameCXHL2400252 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized
2024/03/07Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2400793 Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized
2024/03/07Generic · Class 3 Bromhexine Hydrochloride InjectionCYHS2400788 Anhui Xin Shi Ji Pharma Co., Ltd. romanized; Ping Guang Pharmaceutical Co., Ltd. romanized
2024/03/07Generic · Class 3 Esmolol Hydrochloride InjectionCYHS2400786 Hebei Long Hai Pharma Co., Ltd. romanized; Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized
2024/03/07New drug · Class 1.1 母苏颗粒 · No verified English nameCXZL2400013 Rui Yang Pharmaceutical Co., Ltd. romanized
2024/03/07New drug · Class 1 SYS6002 · No verified English nameCXSL2400174 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized

54 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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