YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 335 drug applications between 13 November 2025 and 19 November 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 79, covering 57 drug names.

2025/11/13 – 2025/11/19

Period
2025/11/13 to 2025/11/19, 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
335
Drugs with new generic filings (by drug name, de-duplicated)
57
Accepted this week, now under review
85

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

335filings, 79 of them generic

By application type

Application typeFilings
Supplement172
Generic79
New drug55
Import17
Unspecified6
Import re-registration6

By drug type

Drug typeFilings
Chemical drug205
TCM87
Therapeutic biologic33
Prophylactic biologic8
Biologic2

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

57 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Lisdexamfetamine Dimesylate capsules414
2Polyvinyl Alcohol Eye Drops3324
3二甲硅油乳剂 · No verified English name3214
4Brexpiprazole Tablets3131
5MOVICOL Ready To Take Sachet, Powder For Oral Solution2216
6氧 · No verified English name2215
7依伏卡塞片 · No verified English name219
8Furosemide Oral Solution218
9Ibuprofen Granules213
10Tolvaptan Orally Disintegrating Tablets215

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

205 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Bayer Vital GmbH1410
2Hunan Ke Lun Pharmaceutical Co., Ltd. romanized832
3Hunan Nuo Na Pharmaceuticals Technology Co., Ltd. romanized770
4CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD741
5Jin Yao Da Ren Tang Group Co., Ltd. Le Ren Tang Pharmaceutical Factory romanized550
6Gansu Tian Shui Qi Huang Pharma Co., Ltd. romanized550
7Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized542
8Qilu Pharmaceutical Co., Ltd.541
9Eli Lilly and Company430
10Takeda Development Center Americas Inc.420

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

105 this week

AcceptedDrugApplicants
2025/11/19Import · Class 1 盐酸伊可白滞素片 · No verified English nameJXHS2500133 Janssen-Cilag International NV; JANSSEN CILAG S.P.A.; Xian Janssen Pharmaceutical Ltd.
2025/11/19Generic · Class 3 利格列汀二甲双胍缓释片(I) · No verified English nameCYHS2504008 Jiangsu Deyuan Pharmaceutical Co.,Ltd.
2025/11/19Generic · Class 3 Tolvaptan Orally Disintegrating TabletsCYHS2504007 TIANJIN LISHENG PHARMACEUTICAL CO., LTD; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2025/11/19Generic · Class 3 Lisdexamfetamine Dimesylate capsulesCYHS2504006 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2025/11/19Generic · Class 3 Tolvaptan Orally Disintegrating TabletsCYHS2504005 TIANJIN LISHENG PHARMACEUTICAL CO., LTD; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2025/11/19Generic · Class 3 Lisdexamfetamine Dimesylate capsulesCYHS2504004 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2025/11/19Generic · Class 3 Lisdexamfetamine Dimesylate capsulesCYHS2504003 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2025/11/19Generic · Class 3 Glycerol Fructose And Sodium Chloride InjectionCYHS2504002 Guangdong Da Xiang Pharmaceutical Co., Ltd. romanized
2025/11/19Generic · Class 3 Lisdexamfetamine Dimesylate capsulesCYHS2504001 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2025/11/19Generic · Class 3 Glycerol Fructose And Sodium Chloride InjectionCYHS2504000 Guangdong Da Xiang Pharmaceutical Co., Ltd. romanized
2025/11/19Generic · Class 3 小儿复方氨基酸注射液(20AA) · No verified English nameCYHS2503999 Yuan Da Yi Xue Ying Yang Ke Xue (Wuhan) Co., Ltd. romanized
2025/11/19Generic · Class 3 Ciclosporin Eye Drops(Ⅱ)CYHL2500206 Beijing Hui En Lan De Pharmaceutical Co., Ltd. romanized
2025/11/19New drug · Class 1 JH021注射液 · No verified English nameCXSL2500987 Bai Tai Bio Pharma Co., Ltd. romanized; An Bo Tai Ke Pharma Co., Ltd. romanized
2025/11/19New drug · Class 1 注射用DB-1311 · No verified English nameCXSL2500986 Ying En Biopharmaceutical (Suzhou) Co., Ltd. romanized
2025/11/19New drug · Class 1 Pumitamig注射液 · No verified English nameCXSL2500985 Bai Shi Mei Shi Gui Bao (Zhongguo) Investment Co., Ltd. romanized; Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized
2025/11/19New drug · Class 1 YSC001注射液 · No verified English nameCXSL2500984 Yan Sheng Chao (Beijing) Bio Technology Co., Ltd. romanized
2025/11/19New drug · Class 1.3 重组三价流感病毒疫苗(Sf9细胞) · No verified English nameCXSL2500983 Chengdu Wei Si Ke Biopharmaceuticals Co., Ltd. romanized; Beijing Wei Si Ke Biopharmaceuticals Technology Co., Ltd. romanized; Wei Si Ke Biopharmaceuticals (Guangzhou) Co., Ltd. romanized
2025/11/19New drug · Class 1.3 重组三价流感病毒疫苗(Sf9细胞) · No verified English nameCXSL2500982 Chengdu Wei Si Ke Biopharmaceuticals Co., Ltd. romanized; Beijing Wei Si Ke Biopharmaceuticals Technology Co., Ltd. romanized; Wei Si Ke Biopharmaceuticals (Guangzhou) Co., Ltd. romanized
2025/11/19New drug · Class 1 ZL-1503注射液 · No verified English nameCXSL2500981 Zai Ding Pharmaceuticals (Shanghai) Co., Ltd. romanized
2025/11/19New drug · Class 1 BG-75098片 · No verified English nameCXHL2501273 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2025/11/19New drug · Class 1 BG-75098片 · No verified English nameCXHL2501272 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2025/11/19New drug · Class 1 BG-75098片 · No verified English nameCXHL2501271 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2025/11/19New drug · Class 1 PAN-90806滴眼液 · No verified English nameCXHL2501270 Zhao Ke (Guangzhou) Yan Ke Drug Co., Ltd. romanized
2025/11/19New drug · Class 2.3 氨氯地平双叶酸片 · No verified English nameCXHL2501269 Shenzhen Ao Sa Pharmaceutical Co., Ltd. romanized
2025/11/18Import · Class 1 Zasocitinib (TAK-279) 胶囊 · No verified English nameJXHL2500355 Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd
2025/11/18Generic · Class 3 Ketorolac Trometamol TabletsCYHS2503994 Jiangsu He Chen Pharma Co., Ltd. romanized
2025/11/18Generic · Class 3 硫酸特布他林口服溶液 · No verified English nameCYHS2503992 Wuhan Yi Bo Yuan Pharmaceuticals Technology Co., Ltd. romanized; Chi Feng Yuan Sheng Pharma Co., Ltd. romanized
2025/11/18Generic · Class 3 复方聚乙二醇(3350)电解质散 · No verified English nameCYHS2503991 Shanghai Zhao Hui Pharma Co., Ltd. romanized
2025/11/18Generic · Class 3 MOVICOL Ready To Take Sachet, Powder For Oral SolutionCYHS2503990 Hangzhou Min Sheng Drug Research Institute Co., Ltd. romanized; Sichuan Xian Tong Pharma Co., Ltd. romanized
2025/11/18Generic · Class 3 注射用青霉素钠/氯化钠注射液 · No verified English nameCYHS2503986 Hunan Ke Lun Pharmaceutical Co., Ltd. romanized

75 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.