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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 360 drug applications between 26 May 2026 and 1 June 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 56, covering 38 drug names.

2026/05/26 – 2026/06/01

Period
2026/05/26 to 2026/06/01, 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
360
Drugs with new generic filings (by drug name, de-duplicated)
38
Accepted this week, now under review
90

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

360filings, 56 of them generic

By application type

Application typeFilings
Supplement229
Generic56
New drug42
Import19
Unspecified9
Import re-registration5

By drug type

Drug typeFilings
Chemical drug173
TCM131
Therapeutic biologic46
Biologic5
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

38 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1甲硝唑凝胶 · No verified English name5314
2Sufentanil Citrate Injection510
3Chloroprocaine Hydrochloride Injection3210
4Landiolol Hydrochloride for Injection2219
5瑞维那新吸入溶液 · No verified English name2253
6口服溶液用盐酸万古霉素 · No verified English name212
7Promethazine Hydrochloride Injection2111
8Milnacipran Hydrochloride Tablets218
9Mirogabalin Besilate Tablets2161
10Dapagliflozin Tablets2184

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

235 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Changsha Dong Feng Pharma Co., Ltd. romanized660
2Beijing Tong Ren Tang Technology Development Co., Ltd. Pharmaceutical Factory romanized640
3Yi Chang Ren Fu Pharma Co., Ltd. romanized626
4Anhui De Hong Sheng Pharmaceutical Co., Ltd. romanized550
5Jin Yao Da Ren Tang Group Co., Ltd. Le Ren Tang Pharmaceutical Factory romanized550
6Guo Yao Group Xinjiang Pharmaceutical Co., Ltd. romanized540
7Beijing Tong Ren Tang Co., Ltd. Tong Ren Tang Pharmaceutical Factory romanized530
8Guizhou Sheng Ke Hui Pharmaceutical Co., Ltd. romanized440
9Kyowa Kirin Co. Ltd.420
10Eli Lilly Nederland B.V.410

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

91 this week

AcceptedDrugApplicants
2026/06/01Import · Class 2.2 尼卡利单抗注射液 · No verified English nameJXSS2600045 Janssen-Cilag International NV; Vetter Pharma-Fertigung GmbH & Co. KG; Johnson & Johnson Pharmaceutical Ltd.
2026/06/01Import · Class 2.2 尼卡利单抗注射液 · No verified English nameJXSS2600044 Janssen-Cilag International NV; Vetter Pharma-Fertigung GmbH & Co. KG; Johnson & Johnson Pharmaceutical Ltd.
2026/06/01Import · Class 1 ABBV-1758注射液 · No verified English nameJXSL2600125 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2026/06/01Import · Class 2.2 伊奈利珠单抗注射液 · No verified English nameJXSL2600124 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2026/06/01Import · Class 1 LY4257496注射液 · No verified English nameJXHL2600193 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2026/06/01Generic · Class 3 Promethazine Hydrochloride InjectionCYHS2601244 Ya Bao Pharma Group Co., Ltd. romanized
2026/06/01Generic · Class 3 Promethazine Hydrochloride InjectionCYHS2601243 Ya Bao Pharma Group Co., Ltd. romanized
2026/06/01Generic · Class 3 Sivelestat Sodium for InjectionCYHS2601242 Shandong Hao Rui En Pharmaceutical Co., Ltd. romanized
2026/06/01Generic · Class 3 Polycarbophil Calcium TabletsCYHS2601241 Zhejiang Zuo Li Pharma Co., Ltd. romanized
2026/06/01Generic · Class 3 Chloroprocaine Hydrochloride InjectionCYHS2601237 Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized
2026/06/01Generic · Class 3 Landiolol Hydrochloride for InjectionCYHS2601236 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2026/06/01Generic · Class 3 葡萄糖酸氯己定含漱液 · No verified English nameCYHS2601233 Beijing Yuan Fang Tong Da Pharmaceuticals Technology Co., Ltd. romanized; Nanjing Ji Cui Ji Ding Pharmaceuticals Co., Ltd. romanized
2026/06/01Generic · Class 3 Potassium Phosphates InjectionCYHS2601232 Ren He Yi Kang Hui Ze Pharma Hebei Co., Ltd. romanized
2026/06/01Generic · Class 3 中性低钙腹膜透析液(碳酸氢盐-G2.5%) · No verified English nameCYHS2601230 Guangdong Ke Hong Pharma Co., Ltd. romanized
2026/06/01Generic · Class 3 Probucol TabletsCYHS2601226 Ningxia Kang Ya Pharma Co., Ltd. romanized
2026/06/01Generic · Class 3 Chloroprocaine Hydrochloride InjectionCYHS2601220 Beijing Zi Meng Pharmaceuticals Technology Co., Ltd. romanized; Jiu Quan Da De Li Pharmaceutical Co., Ltd. romanized
2026/06/01Generic · Class 3 Chloroprocaine Hydrochloride InjectionCYHS2601219 Beijing Zi Meng Pharmaceuticals Technology Co., Ltd. romanized; Jiu Quan Da De Li Pharmaceutical Co., Ltd. romanized
2026/06/01Generic · Class 3 Dexketoprofen Trometamol InjectionCYHS2601218 Zhong Run Pharma Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized
2026/06/01New drug · Class 2.3 灵莲花颗粒 · No verified English nameCXZL2600050 Zhejiang Zuo Li Pharma Co., Ltd. romanized
2026/06/01New drug · Class 1 GR2302注射液(皮下注射) · No verified English nameCXSL2600589 Zhi Xiang (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized; Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized
2026/06/01New drug · Class 1 GR2302注射液(皮下注射) · No verified English nameCXSL2600588 Zhi Xiang (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized; Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized
2026/06/01New drug · Class 1 GR2302注射液 · No verified English nameCXSL2600587 Zhi Xiang (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized; Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized
2026/06/01New drug · Class 1 SHR-1179注射液 · No verified English nameCXSL2600586 Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/06/01New drug · Class 1 伊匹乌肽散剂 · No verified English nameCXHL2600642 Wen Zhou Yi Cheng Jing Zhan Bio Technology Co., Ltd. romanized
2026/06/01New drug · Class 1 注射用APG-1252 · No verified English nameCXHL2600641 Suzhou Ya Sheng Pharma Co., Ltd. romanized
2026/06/01New drug · Class 1 TRI-611片 · No verified English nameCXHL2600640 Nuo Wei Tai Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2026/06/01New drug · Class 1 TRI-611片 · No verified English nameCXHL2600639 Nuo Wei Tai Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2026/05/29Import · Class 2.2 阿替利珠单抗注射液 · No verified English nameJXSS2600043 Roche Registration GmbH; Roche Diagnostics GmbH; F. Hoffmann-La Roche Ltd; Roche(China)Holding Ltd.
2026/05/29Import · Class 1 INCA33890注射液 · No verified English nameJXSL2600123 Incyte Corporation; Incyte Biosciences (Shanghai) Co. Ltd.
2026/05/29Import · Class 1 Ponsegromab注射液 · No verified English nameJXSL2600122 Pfizer Inc.; Pfizer (China) Research and Development Co. Ltd.

61 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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