YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 223 drug applications between 14 January 2021 and 20 January 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 27, covering 20 drug names.

2021/01/14 – 2021/01/20

Period
2021/01/14 to 2021/01/20, 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
223
Drugs with new generic filings (by drug name, de-duplicated)
20
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

223filings, 27 of them generic

By application type

Application typeFilings
Supplement128
New drug30
Generic27
Import19
Unspecified13
Import re-registration6

By drug type

Drug typeFilings
Chemical drug178
Therapeutic biologic38
TCM4
Prophylactic biologic2
In vitro diagnostic reagent1

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

20 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Lacosamide Oral Solution220
2Oseltamivir Phosphate Capsules2239
3Levocarnitine Injection214
4Thiotepa for Injection210
5Duloxetine Hydrochloride Enteric Capsules214
6Citicoline Sodium Injection213
7Dabigatran Etexilate Capsules212
8Ornidazole Injection110
9Nimodipine Oral Solution114
10Plerixafor Injection111

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

130 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hunan Ke Lun Pharmaceutical Co., Ltd. romanized610
2Boehringer Ingelheim International GmbH530
3Sichuan Kelun Pharmaceutical Co., Ltd.532
4GUERBET510
5Guilin Pharmaceutical Co. Ltd China510
6Qilu Pharmaceutical Co., Ltd.442
7Dong Guan Shi Dong Yang Guang Bio Yao Research and Development Co., Ltd. romanized420
8Shandong Yu Man Kun Bio Technology Co., Ltd. romanized424
9Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized422
10Haikou Shi Pharmaceutical Factory Co., Ltd. romanized420

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

50 this week

AcceptedDrugApplicants
2021/01/20Import · Class 3.1 注射用司妥昔单抗 · No verified English nameJXSS2100005 EUSA Pharma (Netherlands) B.V.; Cilag AG
2021/01/20Import · Class 3.1 注射用司妥昔单抗 · No verified English nameJXSS2100004 EUSA Pharma (Netherlands) B.V.; Cilag AG
2021/01/20Import · Class 1 IMGN853 · No verified English nameJXSL2100009 ImmunoGen Inc.
2021/01/20Import · Class 1 RO7445482注射液 · No verified English nameJXHL2100021 F. Hoffmann-La Roche Ltd.
2021/01/20New drug · Class 3.3 德谷胰岛素注射液 · No verified English nameCXSL2100024 Dong Guan Shi Dong Yang Guang Bio Yao Research and Development Co., Ltd. romanized
2021/01/20New drug · Class 1 异体内皮祖细胞(EPCs)注射液 · No verified English nameCXSL2100023 Cheng Nuo Zai Sheng Yi Xue Technology (Zhuhai Heng Qin Xin Qu) Co., Ltd. romanized
2021/01/20New drug · Class 1 JMT601注射液 · No verified English nameCXSL2100022 Shanghai Jin Man Te Bio Technology Co., Ltd. romanized
2021/01/20New drug · Class 1 HEC88473注射液 · No verified English nameCXSL2100021 Dong Guan Shi Dong Yang Guang Bio Yao Research and Development Co., Ltd. romanized
2021/01/20New drug · Class 1 HEC88473注射液 · No verified English nameCXSL2100020 Dong Guan Shi Dong Yang Guang Bio Yao Research and Development Co., Ltd. romanized
2021/01/20New drug · Class 1 RO7049389片 · No verified English nameCXHL2100038 Luo Shi Research and Development (Zhongguo) Co., Ltd. romanized
2021/01/20New drug · Class 1 RO7049389片 · No verified English nameCXHL2100037 Luo Shi Research and Development (Zhongguo) Co., Ltd. romanized
2021/01/19Import · Class 2.2 阿替利珠单抗注射液 · No verified English nameJXSL2100008 F.Hoffmann-La Roche Ltd
2021/01/19Import · Class 1 BI685509片 · No verified English nameJXHL2100020 Boehringer Ingelheim International GmbH
2021/01/19Import · Class 1 BI685509片 · No verified English nameJXHL2100019 Boehringer Ingelheim International GmbH
2021/01/19Import · Class 1 BI685509片 · No verified English nameJXHL2100018 Boehringer Ingelheim International GmbH
2021/01/19Generic · Class 3 Ornidazole InjectionCYHS2100074 Xian Wan Long Pharmaceutical Co., Ltd. romanized
2021/01/19Generic · Class 3 Nimodipine Oral SolutionCYHS2100073 Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized; Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized
2021/01/19Generic · Class 3 Olprinone Hydrochloride InjectionCYHS2100070 Ji Chuan Pharma Group Co., Ltd. romanized
2021/01/19New drug · Class 3.3 特立帕肽注射液 · No verified English nameCXSS2100011 Xin Li Tai (Suzhou) Pharma Co., Ltd. romanized
2021/01/19New drug · Class 1 HEC88473注射液 · No verified English nameCXSL2100019 Dong Guan Shi Dong Yang Guang Bio Yao Research and Development Co., Ltd. romanized
2021/01/19New drug · Class 2.2 贝伐珠单抗注射液 · No verified English nameCXSL2100018 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2021/01/19New drug · Class 1 SHR-1701注射液 · No verified English nameCXSL2100017 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2021/01/19New drug · Class 1 NR082眼用注射液 · No verified English nameCXSL2100016 Wuhan Niu Fu Si Bio Technology Co., Ltd. romanized
2021/01/19New drug · Class 1 HRS2543片 · No verified English nameCXHL2100036 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/01/19New drug · Class 1 HRS2543片 · No verified English nameCXHL2100035 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/01/19New drug · Class 1 HRS2543片 · No verified English nameCXHL2100034 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/01/19New drug · Class 2.4 甲磺酸阿美替尼片 · No verified English nameCXHL2100033 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized
2021/01/19New drug · Class 1 双环铂注射液 · No verified English nameCXHL2100032 Beijing Suo Pu Xing Da Pharmaceuticals Research Co., Ltd. romanized
2021/01/18New drug · Class 1 西奥罗尼胶囊 · No verified English nameCXHL2100009 Shenzhen Wei Xin Bio Technology Co., Ltd. romanized
2021/01/16Import · Class 1 JDQ443片 · No verified English nameJXHL2100017 Novartis Pharma AG

20 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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