YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 219 drug applications between 13 January 2021 and 19 January 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 32, covering 25 drug names.

2021/01/13 – 2021/01/19

Period
2021/01/13 to 2021/01/19, 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
219
Drugs with new generic filings (by drug name, de-duplicated)
25
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

219filings, 32 of them generic

By application type

Application typeFilings
Supplement124
Generic32
New drug32
Import14
Unspecified12
Import re-registration5

By drug type

Drug typeFilings
Chemical drug182
Therapeutic biologic32
TCM3
In vitro diagnostic reagent1
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

25 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Lacosamide Oral Solution220
2Oseltamivir Phosphate Capsules2239
3Crizotinib Capsules217
4Thiotepa for Injection210
5Duloxetine Hydrochloride Enteric Capsules214
6Citicoline Sodium Injection213
7Dabigatran Etexilate Capsules212
8Diquafosol Sodium Eye Drops115
9Desonide Cream110
10Celecoxib Capsules115

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

134 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
6Haikou Shi Pharmaceutical Factory Co., Ltd. romanized420
7Changchun Bio Zhi Pin Research Institute Co., Ltd. romanized420
8Shenzhen Xin Li Tai Pharma Co., Ltd. romanized410
9Xian Yang Sen Pharmaceutical Co., Ltd. romanized410
10Changchun Jin Sai Pharma Co., Ltd. romanized410

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

51 this week

AcceptedDrugApplicants
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
2021/01/16Import · Class 1 JDQ443片 · No verified English nameJXHL2100016 Novartis Pharma AG
2021/01/16Import · Class 1 BI 425809 片 · No verified English nameJXHL2100015 Boehringer Ingelheim International GmbH
2021/01/16New drug · Class 2 乙型肝炎病毒丙型肝炎病毒人类免疫缺陷病毒(1+2型)核酸检测试剂盒(PCR-荧光法) · No verified English nameCXSS2100010 Suzhou Xin Bo Bio Technology Co., Ltd. romanized
2021/01/16New drug · Class 2.4 重组抗EGFR人鼠嵌合单克隆抗体注射液 · No verified English nameCXSL2100015 Bao Chuan Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2021/01/16New drug · Class 2.4 Posaconazole Enteric-coated TabletsCXHL2100031 Shanghai Xuan Tai Pharmaceuticals Technology Co., Ltd. romanized
2021/01/16New drug · Class 2.4 Posaconazole Enteric-coated TabletsCXHL2100030 Shanghai Xuan Tai Pharmaceuticals Technology Co., Ltd. romanized
2021/01/16New drug · Class 1 SAL0104胶囊 · No verified English nameCXHL2100022 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2021/01/15Generic · Class 3 Thiotepa for InjectionCYHS2100063 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/01/15Generic · Class 3 Thiotepa for InjectionCYHS2100062 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/01/15Generic · Class 3 Citicoline Sodium InjectionCYHS2100061 Shandong Yu Man Kun Bio Technology Co., Ltd. romanized; Jiangsu Jiu Xu Pharma Co., Ltd. romanized
2021/01/15Generic · Class 3 Citicoline Sodium InjectionCYHS2100060 Shandong Yu Man Kun Bio Technology Co., Ltd. romanized; Jiangsu Jiu Xu Pharma Co., Ltd. romanized

21 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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