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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 435 drug applications between 5 July 2025 and 11 July 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 108, covering 76 drug names.

2025/07/05 – 2025/07/11

Period
2025/07/05 to 2025/07/11, 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
435
Drugs with new generic filings (by drug name, de-duplicated)
76
Accepted this week, now under review
98

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

435filings, 108 of them generic

By application type

Application typeFilings
Supplement196
Generic108
New drug91
Import26
Import re-registration12
Unspecified2

By drug type

Drug typeFilings
Chemical drug300
Therapeutic biologic68
TCM63
Biologic2
Prophylactic 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

76 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1瑞维那新吸入溶液 · No verified English name4453
2Empagliflozin Tablets4218
3Quetiapine Fumarate Extended-release Tablets410
4Guanfacine Hydrochloride Extended Release Tablets414
5Acyclovir Tablets316
6Pregabalin Oral Solution225
7Bilastine Oral Solution228
8Ilaprazole Enteric-coated Tablets2226
9醋酸钠林格葡萄糖注射液(Ⅰ) · No verified English name222
10Finerenone Tablets2269

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

259 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Heilongjiang Shen Xing Biopharmaceuticals Technology Co., Ltd. romanized18150
2Eli Lilly and Company1030
3Kunming Zhong Pharmaceutical Factory Co., Ltd. romanized860
4Guizhou Yi Bai Nv Zi Da Pharmaceutical Factory Co., Ltd. romanized660
5Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized630
6Celgene Corporation610
7Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized610
8Topfond Pharmaceutical Co., Ltd.550
9Shenzhen Xin Li Tai Pharma Co., Ltd. romanized520
10Karuna Therapeutics Inc.510

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

148 this week

AcceptedDrugApplicants
2025/07/11Import · Class 2.2 替利珠单抗注射液 · No verified English nameJXSL2500120 Sanofi-Aventis Recherche & Développement
2025/07/11Import · Class 1 RO7435846片 · No verified English nameJXHL2500178 F. Hoffmann-La Roche Ltd
2025/07/11Import · Class 1 RO7435846片 · No verified English nameJXHL2500177 F. Hoffmann-La Roche Ltd
2025/07/11Import · Class 1 RO7435846片 · No verified English nameJXHL2500176 F. Hoffmann-La Roche Ltd
2025/07/11Import · Class 1 RO7435846片 · No verified English nameJXHL2500175 F. Hoffmann-La Roche Ltd
2025/07/11Generic · Class 3 Linagliptin and Metformin Hydrochloride Extended Release TabletsCYHS2502482 Beijing Foyou Pharma CO.,LTD
2025/07/11Generic · Class 3 Linagliptin and Metformin Hydrochloride Extended Release TabletsCYHS2502481 Beijing Foyou Pharma CO.,LTD
2025/07/11Generic · Class 3 Oxacillin Sodium for InjectionCYHS2502475 Beijing Yuan Yan Pharmaceuticals Technology Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2025/07/11Generic · Class 3 Oxacillin Sodium for InjectionCYHS2502474 Beijing Yuan Yan Pharmaceuticals Technology Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2025/07/11Generic · Class 3 Guanfacine Hydrochloride Extended Release TabletsCYHS2502473 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2025/07/11Generic · Class 3 Guanfacine Hydrochloride Extended Release TabletsCYHS2502472 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2025/07/11Generic · Class 3 Guanfacine Hydrochloride Extended Release TabletsCYHS2502471 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2025/07/11Generic · Class 3 Guanfacine Hydrochloride Extended Release TabletsCYHS2502470 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2025/07/11Generic · Class 3 Bilastine Oral SolutionCYHS2502467 Zhuhai Bei Shan Bio Technology Co., Ltd. romanized; Jilin Sheng Xi Dian Pharma Technology Development Co., Ltd. romanized
2025/07/11New drug · Class 1 注射用SHR-1802 · No verified English nameCXSL2500572 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/07/11New drug · Class 1 匹康奇拜单抗注射液 · No verified English nameCXSL2500571 Xin Da Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized
2025/07/11New drug · Class 1 匹康奇拜单抗注射液 · No verified English nameCXSL2500570 Xin Da Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized
2025/07/11New drug · Class 1 GR2301注射液 · No verified English nameCXSL2500569 Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized; Zhi Xiang (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2025/07/11New drug · Class 2.2 多西他赛注射用浓溶液(自乳化型) · No verified English nameCXHS2500079 Beijing De Li Ying Jie Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2025/07/11New drug · Class 1 GFH375片 · No verified English nameCXHL2500685 Jin Fang Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2025/07/11New drug · Class 1 HRS-2329片 · No verified English nameCXHL2500684 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/07/11New drug · Class 1 HRS-2329片 · No verified English nameCXHL2500683 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/07/11New drug · Class 1 HRS-2329片 · No verified English nameCXHL2500682 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/07/11New drug · Class 1 CA111注射液 · No verified English nameCXHL2500678 Chongqing Chen An Biopharmaceutical Co., Ltd. romanized
2025/07/11New drug · Class 1 CA111注射液 · No verified English nameCXHL2500677 Chongqing Chen An Biopharmaceutical Co., Ltd. romanized
2025/07/11New drug · Class 1 BIOS-0623-Z4片 · No verified English nameCXHL2500676 Hangzhou Bai Cheng Pharmaceuticals Technology Co., Ltd. romanized
2025/07/11New drug · Class 1 BIOS-0623-Z4片 · No verified English nameCXHL2500675 Hangzhou Bai Cheng Pharmaceuticals Technology Co., Ltd. romanized
2025/07/11New drug · Class 1 LXH-1211片 · No verified English nameCXHL2500674 SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED
2025/07/11New drug · Class 1 LXH-1211片 · No verified English nameCXHL2500673 SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED
2025/07/11New drug · Class 1 LXH-1211片 · No verified English nameCXHL2500672 SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED

118 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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