YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 368 drug applications between 17 January 2025 and 23 January 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 123, covering 86 drug names.

2025/01/17 – 2025/01/23

Period
2025/01/17 to 2025/01/23, 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
368
Drugs with new generic filings (by drug name, de-duplicated)
86
Accepted this week, now under review
13

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

368filings, 123 of them generic

By application type

Application typeFilings
Supplement153
Generic123
New drug67
Import22
Unspecified2
Import re-registration1

By drug type

Drug typeFilings
Chemical drug273
TCM50
Therapeutic biologic40
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

86 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ruxolitinib Phosphate Tablets7327
2Mivacurium Chloride Injection633
3Brexpiprazole Tablets3131
4Lactulose Oral Solution2234
5Piracetam Injection229
6Candesartan Cilexetil and Hydrochlorothiazide Tablets222
7Isavuconazonium Sulfate for Injection2215
8盐酸纳美芬注射液 · No verified English name221
9Sodium Thiosulfate Injection223
10聚乙二醇钠钾散 · No verified English name223

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

237 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized860
2Yunnan Yi Zhi Hao Pharmaceutical Co., Ltd. romanized640
3Anhui Jin Ma Pharma Co., Ltd. romanized550
4AstraZeneca AB540
5Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized535
6Hunan Xian Shi Pharmaceutical Co., Ltd. romanized531
7Fresenius Kabi AB510
8Bristol-Myers Squibb Company440
9Guizhou Heng He Pharmaceutical Co., Ltd. romanized440
10Fu Xing Pharmaceuticals (Xu Zhou) Co., Ltd. romanized432

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

136 this week

AcceptedDrugApplicants
2025/01/23Import · Class 1 MT-7117 片 · No verified English nameJXHL2500014 Mitsubishi Tanabe Pharma Corporation
2025/01/23Generic · Class 3 Levofloxacin InjectionCYHS2500444 Hainan Si Da Pharmaceutical Co., Ltd. romanized
2025/01/23Generic · Class 3 Levofloxacin InjectionCYHS2500443 Hainan Si Da Pharmaceutical Co., Ltd. romanized
2025/01/23Generic · Class 3 Pregabalin Orally Disintegrating TabletsCYHS2500442 Beijing Xing Hao Ying Sheng Pharma Co., Ltd. romanized
2025/01/23Generic · Class 3 Potassium Chloride InjectionCYHS2500440 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2025/01/23Generic · Class 3 氯化钙注射液 · No verified English nameCYHS2500439 Guangdong Jun Kang Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2025/01/23Generic · Class 3 Polaprezinc Orally Disintegrating TabletsCYHS2500438 Hainan Jin Rui Bao Pharmaceuticals Technology Co., Ltd. romanized; Yan Tai Wan Run Pharma Co., Ltd. romanized
2025/01/23Generic · Class 3 盐酸肾上腺素注射液 · No verified English nameCYHS2500435 Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized
2025/01/23Generic · Class 3 Sodium Nitroprusside InjectionCYHS2500433 Zhong Run Pharma Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized
2025/01/23Generic · Class 3 利多卡因喷雾剂 · No verified English nameCYHS2500430 Chongqing Xiang Xue Pharmaceuticals Co., Ltd. romanized; Guangzhou Shi Xiang Xue Pharmaceutical Co., Ltd. romanized
2025/01/23Generic · Class 3 利多卡因喷雾剂 · No verified English nameCYHS2500429 Chongqing Xiang Xue Pharmaceuticals Co., Ltd. romanized; Guangzhou Shi Xiang Xue Pharmaceutical Co., Ltd. romanized
2025/01/23Generic · Class 3 盐酸纳美芬注射液 · No verified English nameCYHS2500421 Zhongshan Wanhan Pharmaceuticals Co., Ltd.
2025/01/23Generic · Class 3 Alendronate Sodium And Sodium Chloride InjectionCYHL2500022 Hunan Xian Shi Pharmaceutical Co., Ltd. romanized
2025/01/23New drug · Class 1.1 安神滴丸 · No verified English nameCXZS2500002 Tian Shi Li Pharmaceuticals Group Co., Ltd. romanized
2025/01/23New drug · Class 1 BNT324 · No verified English nameCXSL2500073 Ying En Biopharmaceutical (Suzhou) Co., Ltd. romanized
2025/01/23New drug · Class 1 BNT327 · No verified English nameCXSL2500072 Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized; Pu Mi Si Bio Technology (Zhuhai) Co., Ltd. romanized
2025/01/23New drug · Class 1 TriCellPr-AC07人脐带间充质干细胞注射液 · No verified English nameCXSL2500071 Ao Chen Bio (Yunnan) Co., Ltd. romanized
2025/01/23New drug · Class 2.3 海博麦布阿托伐他汀钙片 · No verified English nameCXHS2500013 Han Hui Pharmaceutical Co., Ltd. romanized; Zhejiang Hai Zheng Pharma Co., Ltd. romanized
2025/01/23New drug · Class 2.3 海博麦布阿托伐他汀钙片 · No verified English nameCXHS2500012 Han Hui Pharmaceutical Co., Ltd. romanized; Zhejiang Hai Zheng Pharma Co., Ltd. romanized
2025/01/23New drug · Class 2.2 CMC-2310口溶膜 · No verified English nameCXHL2500113 Fu Xing Pharmaceuticals (Xu Zhou) Co., Ltd. romanized
2025/01/23New drug · Class 2.2 CMC-2310口溶膜 · No verified English nameCXHL2500112 Fu Xing Pharmaceuticals (Xu Zhou) Co., Ltd. romanized
2025/01/23New drug · Class 1 HRS-1167片 · No verified English nameCXHL2500111 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/01/23New drug · Class 1 HRS-1167片 · No verified English nameCXHL2500110 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/01/23New drug · Class 1 HRS-1167片 · No verified English nameCXHL2500109 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/01/23New drug · Class 1 TQB3912片 · No verified English nameCXHL2500108 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2025/01/23New drug · Class 1 TQB3912片 · No verified English nameCXHL2500107 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2025/01/23New drug · Class 2.4 HK241雾化吸入溶液 · No verified English nameCXHL2500106 Nanjing Hua Gai Pharmaceutical Co., Ltd. romanized
2025/01/23New drug · Class 2.2 BCM995 · No verified English nameCXHL2500105 Shanghai Yun Cheng Yan Xin Bio Technology Co., Ltd. romanized
2025/01/23New drug · Class 1 BIOS-0618片 · No verified English nameCXHL2500104 Hangzhou Bai Cheng Pharmaceuticals Technology Co., Ltd. romanized
2025/01/23New drug · Class 1 BIOS-0618片 · No verified English nameCXHL2500103 Hangzhou Bai Cheng Pharmaceuticals Technology Co., Ltd. romanized

106 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.