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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 396 drug applications between 12 September 2021 and 18 September 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 61, covering 39 drug names.

2021/09/12 – 2021/09/18

Period
2021/09/12 to 2021/09/18, 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
396
Drugs with new generic filings (by drug name, de-duplicated)
39
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

396filings, 61 of them generic

By application type

Application typeFilings
Supplement224
Generic61
New drug55
Import24
Unspecified20
Import re-registration12

By drug type

Drug typeFilings
Chemical drug286
Therapeutic biologic51
TCM41
Prophylactic biologic11
Biologic7

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

39 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Milrinone Injection320
2Sacubitril Valsartan Sodium Tablets3170
3阿普米司特片 · No verified English name313
4Olmesartan Medoxomil and Hydrochlorothiazide Tablets223
5Tenofovir alafenamide Fumarate Tablets220
6Tedizolid Phosphate For Injection223
7Pitavastatin Calcium Tablets210
8Ambroxol Hydrochloride Solution For Inhalation2110
9Salbutamol Sulfate Inhalation Solution212
10Nilotinib Capsules216

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

222 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Ping Guang Pharmaceutical Co., Ltd. romanized22210
2Hubei Zhang Lian Du Lei Pharmaceutical Co., Ltd. romanized15120
3Bristol-Myers Squibb Pharma EEIG1120
4Guizhou Miao Ren Tang Biopharmaceuticals Technology Co., Ltd. romanized10100
5Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized620
6Zhejiang Tong Yuan Kang Pharmaceuticals Co., Ltd. romanized610
7Sai Ling Pharma Technology Group Co., Ltd. romanized550
8Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized530
9Sun Pharmaceutical Industries Ltd.520
10Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized520

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

85 this week

AcceptedDrugApplicants
2021/09/18Import · Class 1.1 预防性呼吸道合胞病毒疫苗 · No verified English nameJXSL2101111 Janssen Vaccines & Prevention B.V.; Johnson & Johnson (China) Investment Ltd.
2021/09/18Generic · Class 3 Tranexamic Acid InjectionCYHS2101760 Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2021/09/18New drug · Class 1 SHR-1701注射液 · No verified English nameCXSL2101335 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2021/09/18New drug · Class 1 YY-20394片 · No verified English nameCXHL2101490 Shanghai Ying Li Pharma Co., Ltd. romanized
2021/09/18New drug · Class 1 ABM-1310胶囊 · No verified English nameCXHL2101489 Bi Chen (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2021/09/18New drug · Class 1 ABM-1310胶囊 · No verified English nameCXHL2101488 Bi Chen (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2021/09/17Import · Class 2.4 Inclisiran注射液 · No verified English nameJXHL2101180 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd
2021/09/17New drug · Class 2.2 注射用重组葡激酶 · No verified English nameCXSL2101333 Tong Hua Kang Yuan Yu Jin Pharma Co., Ltd. romanized
2021/09/17New drug · Class 1 SHR-2002注射液 · No verified English nameCXSL2101331 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2021/09/17New drug · Class 3.3 冻干人用狂犬病疫苗(Vero细胞) · No verified English nameCXSL2101326 Shanghai Rong Sheng Bio Pharma Co., Ltd. romanized
2021/09/17New drug · Class 2.2; 2.3 替格瑞洛阿司匹林胶囊 · No verified English nameCXHL2101487 Le Pu Pharma Co., Ltd. romanized
2021/09/17New drug · Class 1 注射用APG-1252 · No verified English nameCXHL2101486 Suzhou Ya Sheng Pharma Co., Ltd. romanized
2021/09/17New drug · Class 1 富马酸BGB-10188胶囊 · No verified English nameCXHL2101482 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2021/09/17New drug · Class 1 富马酸BGB-10188胶囊 · No verified English nameCXHL2101481 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2021/09/16Import · Class 2.2 纳武利尤单抗注射液 · No verified English nameJXSS2101022 Bristol-Myers Squibb Pharma EEIG; Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company; Bristol-Myers Squibb (China) Investment Co. Ltd
2021/09/16Import · Class 1 BCX9930片 · No verified English nameJXHL2101178 BioCryst Pharmaceuticals Inc.; Hangzhou Tigermed Consulting Co. Ltd.
2021/09/16Generic · Class 3 利奈唑胺氯化钠注射液 · No verified English nameCYHS2101747 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2021/09/16Generic · Class 3 Ambroxol Hydrochloride Oral SolutionCYHS2101726 Chongqing Jian Neng Pharmaceuticals Kai Fa Co., Ltd. romanized; Sichuan Jian Neng Pharmaceutical Co., Ltd. romanized
2021/09/16New drug · Class 1 斯鲁利单抗注射液 · No verified English nameCXSS2101030 Shanghai Fu Hong Han Lin Biopharmaceutical Co., Ltd. romanized
2021/09/16New drug · Class 1 TG103注射液 · No verified English nameCXSL2101330 Shi Yao Group Bai Ke (Shandong) Biopharmaceutical Co., Ltd. romanized
2021/09/16New drug · Class 1 重组抗PD-1人源化单克隆抗体注射液 · No verified English nameCXSL2101329 San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized
2021/09/16New drug · Class 1 ZG033注射液 · No verified English nameCXSL2101328 Hefei Han Ke Mai Bo Bio Technology Co., Ltd. romanized
2021/09/16New drug · Class 2.2 注射用醋酸曲普瑞林微球 · No verified English nameCXHS2101039 Li Zhu Pharmaceuticals Group Co., Ltd. romanized; Shanghai Li Zhu Pharmaceutical Co., Ltd. romanized
2021/09/16New drug · Class 2.2 他达拉非口腔速溶膜 · No verified English nameCXHL2101485 Sichuan Bai Li Pharma Co., Ltd. romanized
2021/09/16New drug · Class 1 IMP4297胶囊 · No verified English nameCXHL2101484 Shanghai Jun Pai Ying Shi Pharma Co., Ltd. romanized
2021/09/16New drug · Class 1 TT-01688-CL片 · No verified English nameCXHL2101483 Yao Jie An Kang (Nanjing) Technology Co., Ltd. romanized
2021/09/15Import · Class 2.2 纳武利尤单抗注射液 · No verified English nameJXSS2101021 Bristol-Myers Squibb Pharma EEIG; Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company; Bristol-Myers Squibb (China) Investment Co. Ltd
2021/09/15Import · Class 3.1 纳武利尤单抗注射液 · No verified English nameJXSS2101020 Bristol-Myers Squibb Pharma EEIG; Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company; Bristol-Myers Squibb (China) Investment Co. Ltd
2021/09/15Import · Class 3.1 纳武利尤单抗注射液 · No verified English nameJXSS2101019 Bristol-Myers Squibb Pharma EEIG; Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company; Bristol-Myers Squibb (China) Investment Co. Ltd
2021/09/15Import · Class 2.2; 2.4 布地奈德缓释胶囊 · No verified English nameJXHL2101179 EVEREST MEDICINES (SINGAPORE) PTE. LTD.; Everest Medicines (China) Co. Ltd

55 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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