YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 167 drug applications between 14 June 2021 and 20 June 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 25, covering 21 drug names.

2021/06/14 – 2021/06/20

Period
2021/06/14 to 2021/06/20, 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
167
Drugs with new generic filings (by drug name, de-duplicated)
21
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

167filings, 25 of them generic

By application type

Application typeFilings
Supplement94
New drug30
Generic25
Import9
Unspecified8
Import re-registration1

By drug type

Drug typeFilings
Chemical drug122
Therapeutic biologic32
TCM12
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

21 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Levetiracetam Oral Solution223
2头孢克肟胶囊 · No verified English name212
3注射用头孢曲松钠/氯化钠注射液 · No verified English name213
4Magnesium Sulfate Injection217
5Propofol Medium And Long Chain Fat Emulsion Injection113
6吸入用七氟烷 · No verified English name110
7Ipratropium Bromide Inhalation Solution112
8Ambroxol Hydrochloride Solution For Inhalation1110
9Tenofovir Disoproxil Fumarate Tablets110
10Lamotrigine Dispersible Tablets112

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

103 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Wuhan Fu Xing Bio Pharma Co., Ltd. romanized610
2Dong Bei Pharmaceutical Group Shenyang Di Yi Pharmaceutical Co., Ltd. romanized540
3CSPC OUYI PHARMACEUTICAL CO., LTD.520
4Bayer AG510
5Lian Cardiovascular Limited510
6Haerbin Han Bang Medical Technology Co., Ltd. romanized510
7Hangzhou Sen Ze Pharmaceuticals Technology Co., Ltd. romanized440
8Nang Kuang Pharmaceutical Co. Ltd410
9Aspen OOS B.V330
10ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.333

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

47 this week

AcceptedDrugApplicants
2021/06/18Generic · Class 3 Nifedipine Extended-Release TabletsCYHS2101305 Nanjing Yi Heng Pharmaceutical Co., Ltd. romanized
2021/06/18New drug · Class 1 EX101注射液 · No verified English nameCXSL2101140 Guangzhou Ai Si Mai Biopharmaceuticals Technology Co., Ltd. romanized
2021/06/18New drug · Class 1 重组人源化抗表皮生长因子受体单克隆抗体注射液 · No verified English nameCXSL2101139 Shanghai Jin Man Te Bio Technology Co., Ltd. romanized
2021/06/18New drug · Class 1 重组抗PD-1全人源单克隆抗体注射液 · No verified English nameCXSL2101138 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2021/06/18New drug · Class 1 注射用IMM01 · No verified English nameCXSL2101109 Yi Ming Ang Ke Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2021/06/18New drug · Class 1 SYHX1901片 · No verified English nameCXHL2101206 CSPC OUYI PHARMACEUTICAL CO., LTD.
2021/06/18New drug · Class 1 SYHX1901片 · No verified English nameCXHL2101205 CSPC OUYI PHARMACEUTICAL CO., LTD.
2021/06/18New drug · Class 2.4 注射用苏拉明钠 · No verified English nameCXHL2101187 Guangdong Kang Da Pharmaceutical Co., Ltd. romanized
2021/06/17Import · Class 1 注射用STP705 · No verified English nameJXHL2101092 Sirnaomics Inc.; Sirnaomics Biopharmaceuticals (Suzhou) Co. Ltd.
2021/06/17Generic · Class 3 头孢克肟胶囊 · No verified English nameCYHS2101301 Shandong Yu Xin Pharma Co., Ltd. romanized; Shandong Luo Xin Pharma Group Co., Ltd. romanized
2021/06/17Generic · Class 3 头孢克肟胶囊 · No verified English nameCYHS2101300 Shandong Yu Xin Pharma Co., Ltd. romanized; Shandong Luo Xin Pharma Group Co., Ltd. romanized
2021/06/17Generic · Class 3 Magnesium Sulfate InjectionCYHS2101298 Shijiazhuang Xing Ze Pharmaceuticals Technology Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2021/06/17Generic · Class 3 Magnesium Sulfate InjectionCYHS2101297 Shijiazhuang Xing Ze Pharmaceuticals Technology Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2021/06/17Generic · Class 3 Treprostinil InjectionCYHS2101273 Jiangsu Zhong Qiang Pharma Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2021/06/17New drug · Class 2.2 康复新肠溶胶囊 · No verified English nameCXZL2101012 ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.
2021/06/17New drug · Class 1 重组仙台病毒/Ⅱ型单纯疱疹病毒注射液 · No verified English nameCXSL2101136 Guo Yao Zhong Sheng Bio Technology Research Institute Co., Ltd. romanized
2021/06/17New drug · Class 1 SHR-1316注射液 · No verified English nameCXSL2101129 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2021/06/17New drug · Class 1 IBI110 · No verified English nameCXSL2101126 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2021/06/17New drug · Class 2.2 贝伐珠单抗注射液 · No verified English nameCXSL2101125 Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized
2021/06/17New drug · Class 1 斯鲁利单抗注射液 · No verified English nameCXSL2101124 Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized
2021/06/17New drug · Class 1 注射用SMET12 · No verified English nameCXSL2101118 Zhejiang Shi Mai Pharma Co., Ltd. romanized
2021/06/17New drug · Class 1 APG-2575片 · No verified English nameCXHL2101210 Suzhou Ya Sheng Pharma Co., Ltd. romanized
2021/06/17New drug · Class 1 APG-2575片 · No verified English nameCXHL2101209 Suzhou Ya Sheng Pharma Co., Ltd. romanized
2021/06/17New drug · Class 1 SYHX1901片 · No verified English nameCXHL2101208 CSPC OUYI PHARMACEUTICAL CO., LTD.
2021/06/17New drug · Class 1 SYHX1901片 · No verified English nameCXHL2101207 CSPC OUYI PHARMACEUTICAL CO., LTD.
2021/06/17New drug · Class 2.2; 2.3 普拉克索雷沙吉兰缓释胶囊 · No verified English nameCXHL2101204 ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.
2021/06/16Generic · Class 3 Ambroxol Hydrochloride Solution For InhalationCYHL2101016 Tai Yang Sheng (Bo Zhou) Biopharmaceuticals Technology Co., Ltd. romanized
2021/06/16New drug · Class 1 AK104注射液 · No verified English nameCXSL2101137 Kang Fang Pharma Co., Ltd. romanized
2021/06/15Import · Class 2.2 帕博利珠单抗注射液 · No verified English nameJXSL2101041 Merck Sharp & Dohme Corp.; MSD R&D(China)Co. Ltd.
2021/06/15Import · Class 1 Mavacamten胶囊 · No verified English nameJXHL2101091 Lian Cardiovascular Limited; Shanghai LianBio Development Co. Ltd.

17 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.

Subscribe to the weekly

No account needed.

The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.

A text version of this report, weekly, in the language you subscribe in. You will receive one confirmation email first; sending starts only after you click its link. Every issue carries an unsubscribe link.