YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 382 drug applications between 8 November 2024 and 14 November 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 115, covering 76 drug names.

2024/11/08 – 2024/11/14

Period
2024/11/08 to 2024/11/14, 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
382
Drugs with new generic filings (by drug name, de-duplicated)
76
Accepted this week, now under review
8

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

382filings, 115 of them generic

By application type

Application typeFilings
Supplement172
Generic115
New drug69
Import13
Unspecified7
Import re-registration6

By drug type

Drug typeFilings
Chemical drug276
TCM54
Therapeutic biologic39
Prophylactic biologic11
In vitro diagnostic reagent1
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

76 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Vonoprazan Fumarate Tablets4260
2Propranolol Hydrochloride Injection424
3Fluoxetine Hydrochloride Oral Solution410
4Isavuconazonium Sulfate for Injection3315
5Glucosamine Sulfate Capsules3351
6Nicergoline Tablets321
7Brexpiprazole Tablets3131
8Sodium sulfate, magnesium sulfate, and potassium chloride Tablets222
9Formoterol Fumarate Inhalation Solution225
10Bisoprolol Fumarate and Amlodipine Besylate Tablets229

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

236 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jin Zhou Fu Shou Tang Pharmaceuticals Technology Co., Ltd. romanized14130
2Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized720
3Wuhan Bio Zhi Pin Research Institute Co., Ltd. romanized640
4Celgene Corporation610
5Chengdu Di Kang Pharma Co., Ltd. romanized550
6Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized520
7Jiangsu Hao Sen Pharma Group Co., Ltd. romanized520
8Chengdu Brilliant Pharmaceutical Co., Ltd.431
9Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized430
10Qilu Pharmaceutical Co., Ltd.432

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

125 this week

AcceptedDrugApplicants
2024/11/14Import · Class 1 注射用MK-2400 · No verified English nameJXSL2400222 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd.
2024/11/14Import · Class 2.2 帕博利珠单抗注射液 · No verified English nameJXSL2400221 Merck Sharp & Dohme LLC; MSD R&D(China)Co. Ltd.
2024/11/14Import · Class 1 Itepekimab注射液 · No verified English nameJXSL2400220 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2024/11/14Generic · Class 3 Latamoxef Sodium for InjectionCYHS2403909 Hainan Brilliant Pharmaceutical Co., Ltd.
2024/11/14Generic · Class 3 Latamoxef Sodium for InjectionCYHS2403908 Hainan Brilliant Pharmaceutical Co., Ltd.
2024/11/14Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2403905 Kang Pu Pharma Co., Ltd. romanized
2024/11/14Generic · Class 3 Cefmetazole Sodium for InjectionCYHS2403901 Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized; Shenyang San Jiu Pharma Co., Ltd. romanized
2024/11/14Generic · Class 3 Cefmetazole Sodium for InjectionCYHS2403900 Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized; Shenyang San Jiu Pharma Co., Ltd. romanized
2024/11/14Generic · Class 3 Sodium Bicarbonate InjectionCYHS2403899 Beijing Min Kang Bai Cao Pharmaceuticals Technology Co., Ltd. romanized; Wuhan Fu Xing Bio Pharma Co., Ltd. romanized
2024/11/14Generic · Class 3 Propranolol Hydrochloride InjectionCYHS2403897 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2024/11/14Generic · Class 3 Propranolol Hydrochloride InjectionCYHS2403896 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2024/11/14Generic · Class 3 Thioctic Acid TabletsCYHS2403894 Shandong Lu Ning Pharma Co., Ltd. romanized
2024/11/14Generic · Class 3 Thioctic Acid TabletsCYHS2403893 Shandong Lu Ning Pharma Co., Ltd. romanized
2024/11/14Generic · Class 3 Ketorolac Trometamol TabletsCYHS2403892 Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized
2024/11/14Generic · Class 3 Brexpiprazole TabletsCYHL2400226 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2024/11/14Generic · Class 3 Brexpiprazole TabletsCYHL2400225 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2024/11/14Generic · Class 3 Brexpiprazole TabletsCYHL2400224 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2024/11/14Generic · Class 3 伏环孢素软胶囊 · No verified English nameCYHL2400223 Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized
2024/11/14New drug · Class 1.1 柴芩宁神颗粒 · No verified English nameCXZL2400078 Shanxi Sheng Zhong Pharmaceuticals Research Institute (Shanxi Sheng Zhong Hospital) romanized
2024/11/14New drug · Class 3.3 流感病毒裂解疫苗 · No verified English nameCXSS2400122 Wuhan Bio Zhi Pin Research Institute Co., Ltd. romanized
2024/11/14New drug · Class 3.3 流感病毒裂解疫苗 · No verified English nameCXSS2400121 Wuhan Bio Zhi Pin Research Institute Co., Ltd. romanized
2024/11/14New drug · Class 1 AK129注射液 · No verified English nameCXSL2400776 Kang Fang Hui Ke (Shanghai) Bio Co., Ltd. romanized
2024/11/14New drug · Class 1 GC310腺相关病毒注射液 · No verified English nameCXSL2400775 Beijing Jin Lan Ji Yin Technology Co., Ltd. romanized
2024/11/14New drug · Class 1 GC310腺相关病毒注射液 · No verified English nameCXSL2400774 Beijing Jin Lan Ji Yin Technology Co., Ltd. romanized
2024/11/14New drug · Class 1 ICG318 CAR-T细胞注射液 · No verified English nameCXSL2400773 Song He Mian Yi Bio Medical (Shenzhen) Co., Ltd. romanized
2024/11/14New drug · Class 2.2; 2.4 葡萄糖缓释颗粒 · No verified English nameCXHL2401236 Beijing Ke Xin Bi Cheng Pharmaceuticals Technology Development Co., Ltd. romanized
2024/11/14New drug · Class 1 NEP018片 · No verified English nameCXHL2401235 Shenzhen Hai Wang Pharmaceuticals Technology Research Institute Co., Ltd. romanized
2024/11/14New drug · Class 1 BG-60366片 · No verified English nameCXHL2401234 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2024/11/14New drug · Class 1 BG-60366片 · No verified English nameCXHL2401233 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2024/11/14New drug · Class 2.2 司美格鲁肽注射液 · No verified English nameCXHL2401232 Hainan Zhong He Pharma Co., Ltd. romanized

95 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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