YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 381 drug applications between 10 December 2021 and 16 December 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 43, covering 33 drug names.

2021/12/10 – 2021/12/16

Period
2021/12/10 to 2021/12/16, 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
381
Drugs with new generic filings (by drug name, de-duplicated)
33
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

381filings, 43 of them generic

By application type

Application typeFilings
Supplement254
New drug58
Generic43
Import re-registration11
Import10
Unspecified5

By drug type

Drug typeFilings
Chemical drug273
TCM61
Therapeutic biologic42
Prophylactic biologic5

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

33 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Guanfacine Hydrochloride Extended Release Tablets414
2盐酸左沙丁胺醇雾化吸入溶液 · No verified English name312
3Ambroxol Hydrochloride Solution For Inhalation2210
4Vildagliptin Tablets220
5Sildenafil Citrate Tablets2112
6Nafamostat Mesilate for Injection2138
7Febuxostat Tablets2112
8Clotrimazole Vaginal Tablets113
9Diquafosol Sodium Eye Drops115
10Desonide Cream110

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

166 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hua Run Shuang He Pharma Co., Ltd. romanized76660
2Jilin Sheng Shen Lu Pharmaceutical Co., Ltd. romanized26210
3Haerbin Tian Mei Pharma Co., Ltd. romanized1060
4Zhengzhou Yu Gang Zhi Xing Pharmaceutical Co., Ltd. romanized870
5Yi Chang Ren Fu Pharma Co., Ltd. romanized735
6Guizhou Liang Ji Pharma Co., Ltd. romanized660
7Heilongjiang Kui Hua Pharma Co., Ltd. romanized650
8Janssen-Cilag International NV610
9Ha Yao Group Zhong Yao Er Factory romanized540
10Da Lian Jin Ding Chang Pharmaceuticals Technology Co., Ltd. romanized440

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

81 this week

AcceptedDrugApplicants
2021/12/16Import · Class 1 甲磺酸氢甲硫堇(LMTM)片 · No verified English nameJXHL2101273 TauRx Therapeutics Ltd.; dMed Biopharmaceutical Co. Ltd.
2021/12/16Import · Class 1 AZD8233注射液 · No verified English nameJXHL2101272 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2021/12/16Generic · Class 3 Levocetirizine dihydrochloride Oral SolutionCYHS2102212 Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized
2021/12/16Generic · Class 3 Nafamostat Mesilate for InjectionCYHS2102211 Beijing Sai Sheng Pharma Co., Ltd. romanized
2021/12/16Generic · Class 3 Nafamostat Mesilate for InjectionCYHS2102210 Beijing Sai Sheng Pharma Co., Ltd. romanized
2021/12/16Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2102204 Jiangxi Ai Shi Te Pharmaceutical Co., Ltd. romanized
2021/12/16Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2102203 Jiangxi Ai Shi Te Pharmaceutical Co., Ltd. romanized
2021/12/16Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2102202 Jiangxi Ai Shi Te Pharmaceutical Co., Ltd. romanized
2021/12/16Generic · Class 3 Ambroxol Hydrochloride Solution For InhalationCYHS2102201 Nanjing Hua Gai Pharmaceutical Co., Ltd. romanized
2021/12/16Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2102196 Haikou Shi Pharmaceutical Factory Co., Ltd. romanized; Hainan He Rui Pharmaceutical Co., Ltd. romanized
2021/12/16New drug · Class 3.3 阿达木单抗注射液 · No verified English nameCXSS2101064 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2021/12/16New drug · Class 1.1 重组十五价人乳头瘤病毒疫苗(大肠埃希菌) · No verified English nameCXSL2101487 Beijing Kang Le Wei Shi Bio Technology Co., Ltd. romanized; Liaoning Cheng Da Bio Co., Ltd. romanized
2021/12/16New drug · Class 2.1 IBI311 · No verified English nameCXSL2101482 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2021/12/16New drug · Class 1 PM8002注射液 · No verified English nameCXSL2101477 Pu Mi Si Bio Technology (Zhuhai) Co., Ltd. romanized
2021/12/16New drug · Class 1 注射用TFX05-01 · No verified English nameCXHL2101767 Shenzhen Yang Li Pharmaceuticals Technology Co., Ltd. romanized
2021/12/16New drug · Class 1 HE006片 · No verified English nameCXHL2101766 Nanchang Hong Yi Pharma Co., Ltd. romanized
2021/12/16New drug · Class 1 HE006片 · No verified English nameCXHL2101765 Nanchang Hong Yi Pharma Co., Ltd. romanized
2021/12/16New drug · Class 1 D-1553片 · No verified English nameCXHL2101764 Yi Fang Bio Technology (Shanghai) Co., Ltd. romanized
2021/12/16New drug · Class 1 D-1553片 · No verified English nameCXHL2101763 Yi Fang Bio Technology (Shanghai) Co., Ltd. romanized
2021/12/16New drug · Class 1 IN10018片 · No verified English nameCXHL2101762 Ying Shi Bio Technology (Shanghai) Co., Ltd. romanized
2021/12/16New drug · Class 1 IN10018片 · No verified English nameCXHL2101761 Ying Shi Bio Technology (Shanghai) Co., Ltd. romanized
2021/12/16New drug · Class 1 JYP0061片 · No verified English nameCXHL2101760 Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized
2021/12/16New drug · Class 1 JYP0061片 · No verified English nameCXHL2101759 Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized
2021/12/16New drug · Class 1 JYP0061片 · No verified English nameCXHL2101758 Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized
2021/12/16New drug · Class 1 BC0305胶囊 · No verified English nameCXHL2101749 Shandong Dan Hong Pharmaceutical Co., Ltd. romanized
2021/12/16New drug · Class 1 BC0305胶囊 · No verified English nameCXHL2101748 Shandong Dan Hong Pharmaceutical Co., Ltd. romanized
2021/12/16New drug · Class 1 AL01211胶囊 · No verified English nameCXHL2101742 Ai Si Lin Ke (Suzhou) Biopharmaceuticals Co., Ltd. romanized
2021/12/16New drug · Class 1 AL01211胶囊 · No verified English nameCXHL2101741 Ai Si Lin Ke (Suzhou) Biopharmaceuticals Co., Ltd. romanized
2021/12/16New drug · Class 1 AL01211胶囊 · No verified English nameCXHL2101740 Ai Si Lin Ke (Suzhou) Biopharmaceuticals Co., Ltd. romanized
2021/12/16New drug · Class 1 注射用ATAP-M8 · No verified English nameCXHL2101734 Beijing Ai Tai Pu Biopharmaceuticals Technology Co., Ltd. romanized

51 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.