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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 289 drug applications between 6 April 2024 and 12 April 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 85, covering 66 drug names.

2024/04/06 – 2024/04/12

Period
2024/04/06 to 2024/04/12, 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
289
Drugs with new generic filings (by drug name, de-duplicated)
66
Accepted this week, now under review
0

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

289filings, 85 of them generic

By application type

Application typeFilings
Supplement116
Generic85
New drug52
Import20
Import re-registration12
Unspecified4

By drug type

Drug typeFilings
Chemical drug206
TCM40
Therapeutic biologic39
Biologic2
Prophylactic 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

66 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Lidocaine and Prilocaine Cream2224
2Potassium Phosphates Injection222
3Levofloxacin Tablets227
4Isavuconazonium Sulfate for Injection2215
5盐酸肾上腺素注射液 · No verified English name226
6Magnesium Sulfate, Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution228
7Mirabegron Extended-release Tablets221
8腺苷钴胺胶囊 · No verified English name228
9Palbociclib Capsules210
10Multiple Electrolytes Injection(Ⅱ)211

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

191 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jiangsu Hao Sen Pharma Group Co., Ltd. romanized810
2Boehringer Ingelheim International GmbH520
3Chen Huan Pharmaceuticals Group Co., Ltd. romanized440
4Kunming Zhong Pharmaceutical Factory Co., Ltd. romanized430
5Guangxi Yu Yuan Pharma Co., Ltd. romanized420
6Shu Tai Shen (Beijing) Biopharmaceutical Co., Ltd. romanized420
7Zhejiang Wen Da Pharmaceuticals Technology Co., Ltd. romanized410
8Shandong Feng Huang Pharmaceutical Co., Ltd. romanized330
9Qilu Pharmaceutical Co., Ltd.332
10Hainan Ai Ke Pharmaceutical Co., Ltd. romanized323

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

96 this week

AcceptedDrugApplicants
2024/04/12Import · Class 3.1 注射用罗特西普 · No verified English nameJXSS2400036 Celgene Corporation a Bristol-Myers Squibb Company; Patheon Italia S.p.A.; Bristol-Myers Squibb (China) Investment Co. Ltd
2024/04/12Import · Class 3.1 注射用罗特西普 · No verified English nameJXSS2400035 Celgene Corporation a Bristol-Myers Squibb Company; Patheon Italia S.p.A.; Bristol-Myers Squibb (China) Investment Co. Ltd
2024/04/12Generic · Class 3 水合氯醛灌肠剂 · No verified English nameCYHS2401094 Hong Yue Technology (Hu Zhou) Co., Ltd. romanized; Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized
2024/04/12Generic · Class 3 Ebastine Oral SolutionCYHS2401093 Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized; Hua Yi Pharma Technology (Anhui) Co., Ltd. romanized
2024/04/12Generic · Class 3 Levofloxacin InjectionCYHS2401087 Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized
2024/04/12New drug · Class 3.3 Sabin株脊髓灰质炎灭活疫苗(Vero细胞) · No verified English nameCXSS2400041 Beijing Min Hai Bio Technology Co., Ltd. romanized
2024/04/12New drug · Class 1.3 重组呼吸道合胞病毒疫苗(CHO细胞) · No verified English nameCXSL2400228 Chengdu Hua Ren Kang Bio Technology Co., Ltd. romanized; Shanghai Mai Ke Kang Bio Technology Co., Ltd. romanized
2024/04/12New drug · Class 1 STSP-0902注射液 · No verified English nameCXSL2400227 Shu Tai Shen (Beijing) Biopharmaceutical Co., Ltd. romanized
2024/04/12New drug · Class 1 STSP-0902滴眼液 · No verified English nameCXSL2400226 Shu Tai Shen (Beijing) Biopharmaceutical Co., Ltd. romanized
2024/04/12New drug · Class 1 STSP-0902滴眼液 · No verified English nameCXSL2400225 Shu Tai Shen (Beijing) Biopharmaceutical Co., Ltd. romanized
2024/04/12New drug · Class 1 STSP-0902滴眼液 · No verified English nameCXSL2400224 Shu Tai Shen (Beijing) Biopharmaceutical Co., Ltd. romanized
2024/04/12New drug · Class 1 GH21胶囊 · No verified English nameCXHL2400364 Qin Hao Pharmaceuticals (Suzhou) Co., Ltd. romanized
2024/04/12New drug · Class 1 GH21胶囊 · No verified English nameCXHL2400363 Qin Hao Pharmaceuticals (Suzhou) Co., Ltd. romanized
2024/04/12New drug · Class 1 D-1553片 · No verified English nameCXHL2400362 Shanghai Zheng Da Tian Qing Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2024/04/12New drug · Class 1 WD-890片 · No verified English nameCXHL2400361 Zhejiang Wen Da Pharmaceuticals Technology Co., Ltd. romanized
2024/04/12New drug · Class 1 WD-890片 · No verified English nameCXHL2400360 Zhejiang Wen Da Pharmaceuticals Technology Co., Ltd. romanized
2024/04/12New drug · Class 1 WD-890片 · No verified English nameCXHL2400359 Zhejiang Wen Da Pharmaceuticals Technology Co., Ltd. romanized
2024/04/12New drug · Class 1 WD-890片 · No verified English nameCXHL2400358 Zhejiang Wen Da Pharmaceuticals Technology Co., Ltd. romanized
2024/04/12New drug · Class 1 TQB3702片 · No verified English nameCXHL2400357 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2024/04/12New drug · Class 2.2 BY029口服溶液 · No verified English nameCXHL2400356 Beijing Bai Ya Joint Drug Research Institute Co., Ltd. romanized
2024/04/11Import · Class 3.1 Ravulizumab注射液 · No verified English nameJXSL2400075 Alexion Pharmaceuticals Inc.; AstraZeneca Global R&D (China) Co. Ltd.
2024/04/11Import · Class 1 BI 1819479 片 · No verified English nameJXHL2400089 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2024/04/11Import · Class 1 BI 1819479 片 · No verified English nameJXHL2400088 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2024/04/11Generic · Class 3 Propranolol Hydrochloride InjectionCYHS2401085 Beijing Liu Huan Pharma Co., Ltd. romanized; Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2024/04/11Generic · Class 3 Haloperidol Lactate InjectionCYHS2401083 Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized
2024/04/11Generic · Class 3 Pioglitazone and Metformin Hydrochloride TabletsCYHS2401078 Beijing Bei Lu Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/04/11New drug · Class 1 注射用金纳单抗 · No verified English nameCXSS2400040 Changchun Jin Sai Pharma Co., Ltd. romanized
2024/04/11New drug · Class 1 注射用金纳单抗 · No verified English nameCXSS2400039 Changchun Jin Sai Pharma Co., Ltd. romanized
2024/04/11New drug · Class 1 注射用LM-2417 · No verified English nameCXSL2400223 Li Xin Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2024/04/11New drug · Class 1 YH001胶囊 · No verified English nameCXHL2400355 Hangzhou Yu Hong Pharmaceuticals Technology Co., Ltd. romanized

66 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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