YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 320 drug applications between 12 January 2023 and 18 January 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 76, covering 59 drug names.

2023/01/12 – 2023/01/18

Period
2023/01/12 to 2023/01/18, 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
320
Drugs with new generic filings (by drug name, de-duplicated)
59
Accepted this week, now under review
1

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

320filings, 76 of them generic

By application type

Application typeFilings
Supplement145
Generic76
New drug57
Import18
Import re-registration14
Unspecified10

By drug type

Drug typeFilings
Chemical drug226
TCM47
Therapeutic biologic42
Prophylactic biologic4
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

59 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Nifedipine Controlled-release Tablets317
2Diquafosol Sodium Eye Drops225
3Ganirelix Injection221
4Clindamycin Injection214
5Perindopril and Indapamide Tablets213
6Vonoprazan Fumarate Tablets2160
7Ibuprofen Injection218
8Lafutidine Tablets212
9Piperacillin Sodium for Injection2116
10Desvenlafaxine Extended-release Tablets210

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

201 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Ping Guang Pharmaceutical Co., Ltd. romanized18180
2CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD730
3Sichuan Pharmaceutical Formulations Co., Ltd. romanized610
4Shandong Run Ze Pharmaceutical Co., Ltd. romanized610
5An Yang Guang Sheng Heng Pharmaceutical Co., Ltd. romanized540
6Qilu Pharmaceutical Co., Ltd.443
7Guo Yao Group Guo Rui Pharma Co., Ltd. romanized422
8Ji Chuan Pharma Group Co., Ltd. romanized422
9Zhuhai Lian Bang Pharmaceutical Co., Ltd. romanized420
10Sanofi-aventis groupe410

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

94 this week

AcceptedDrugApplicants
2023/01/18Import · Class 3.1 利妥昔单抗注射液(皮下注射) · No verified English nameJXSS2300012 Roche Pharma (Schweiz) AG; F. Hoffmann-La Roche AG
2023/01/18Import · Class 3.1 帕博利珠单抗注射液 · No verified English nameJXSS2300011 Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd
2023/01/18Import · Class 2.2; 2.4 丙酸氯倍他索纳米混悬滴眼液 · No verified English nameJXHL2300009 Formosa Pharmaceuticals Inc.; Grandpharma (China) Co. Ltd.
2023/01/18New drug · Class 1 QLP2117注射液 · No verified English nameCXSL2300050 Qilu Pharmaceutical Co., Ltd.
2023/01/18New drug · Class 1 重组抗IL-4Rα人源化单克隆抗体注射液 · No verified English nameCXSL2300049 San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized
2023/01/18New drug · Class 2.2 注射用维迪西妥单抗 · No verified English nameCXSL2300048 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2023/01/18New drug · Class 1 注射用FZ-AD004抗体偶联剂 · No verified English nameCXSL2300047 Shanghai Fu Dan Zhang Jiang Biopharmaceuticals Co., Ltd. romanized
2023/01/18New drug · Class 1 FCN-338片 · No verified English nameCXHL2300094 Chongqing Fu Chuang Pharmaceuticals Research Co., Ltd. romanized
2023/01/18New drug · Class 1 FCN-338片 · No verified English nameCXHL2300093 Chongqing Fu Chuang Pharmaceuticals Research Co., Ltd. romanized
2023/01/18New drug · Class 1 FCN-289片 · No verified English nameCXHL2300092 Chongqing Fu Shang Yuan Chuang Pharmaceuticals Technology Co., Ltd. romanized
2023/01/18New drug · Class 1 FCN-289片 · No verified English nameCXHL2300091 Chongqing Fu Shang Yuan Chuang Pharmaceuticals Technology Co., Ltd. romanized
2023/01/18New drug · Class 1 SK-07注射液 · No verified English nameCXHL2300090 Guangzhou Kang Chen Pharma Co., Ltd. romanized
2023/01/18New drug · Class 1 SK-07注射液 · No verified English nameCXHL2300089 Guangzhou Kang Chen Pharma Co., Ltd. romanized
2023/01/18New drug · Class 2.1; 2.2; 2.4 HW-N2001注射液 · No verified English nameCXHL2300088 Shandong Dao He Pharma Co., Ltd. romanized; Wei Fang Yi College romanized
2023/01/17Import · Class 2.2 司库奇尤单抗注射液 · No verified English nameJXSL2300025 Novartis Pharma Schweiz AG; Beijing Novartis Pharma Co. Ltd.
2023/01/17Generic · Class 3 Emtricitabine, Rilpivirine, and Tenofovir Alafenamide TabletsCYHS2300165 Qilu Pharmaceutical Co., Ltd.
2023/01/17Generic · Class 3 Ibuprofen InjectionCYHS2300163 Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized
2023/01/17Generic · Class 3 Ibuprofen InjectionCYHS2300162 Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized
2023/01/17Generic · Class 3 Fosaprepitant Dimeglumine for InjectionCYHS2300157 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2023/01/17Generic · Class 3 Pentoxifylline InjectionCYHS2300156 Shandong Qidu Pharmaceutical Co., Ltd.
2023/01/17Generic · Class 3 Lafutidine TabletsCYHS2300155 Ji Chuan Pharma Group Co., Ltd. romanized
2023/01/17Generic · Class 3 Lafutidine TabletsCYHS2300154 Ji Chuan Pharma Group Co., Ltd. romanized
2023/01/17Generic · Class 3 生理氯化钠溶液 · No verified English nameCYHS2300148 Jilin Sheng Dou Bang Pharma Co., Ltd. romanized
2023/01/17Generic · Class 3 Dienogest TabletsCYHL2300007 Shanghai Hui Lun Pharmaceuticals Co., Ltd. romanized
2023/01/17New drug · Class 1.1 异功散颗粒 · No verified English nameCXZL2300002 Shen Wei Pharma Group Co., Ltd. romanized
2023/01/17New drug · Class 1 重组人内皮抑素腺病毒注射液 · No verified English nameCXSL2300046 Guangzhou Da Bo Bio Zhi Pin Co., Ltd. romanized
2023/01/17New drug · Class 1 注射用SHR-9839 · No verified English nameCXSL2300044 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/01/17New drug · Class 1 注射用BC3195 · No verified English nameCXSL2300043 Wuxi Zhi Kang Hong Yi Bio Technology Co., Ltd. romanized
2023/01/17New drug · Class 2.2 替雷利珠单抗注射液 · No verified English nameCXSL2300042 Bai Ji Shen Zhou (Shanghai) Bio Technology Co., Ltd. romanized
2023/01/17New drug · Class 1 IMC002注射液 · No verified English nameCXSL2300041 Suzhou Yi Mu Feng Bio Technology Co., Ltd. romanized

64 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.