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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 502 drug applications between 19 December 2025 and 25 December 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 99, covering 70 drug names.

2025/12/19 – 2025/12/25

Period
2025/12/19 to 2025/12/25, 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
502
Drugs with new generic filings (by drug name, de-duplicated)
70
Accepted this week, now under review
106

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

502filings, 99 of them generic

By application type

Application typeFilings
Supplement234
New drug118
Generic99
Import18
Import re-registration17
Unspecified16

By drug type

Drug typeFilings
Chemical drug267
TCM129
Therapeutic biologic94
Biologic6
Prophylactic biologic6

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

70 drugs with new generic filings; top 10 listed

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

267 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jilin Sheng De Shang Pharma Co., Ltd. romanized37310
2Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized17170
3Amgen Inc.1320
4Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized1020
5AstraZeneca AB950
6medac Gesellschaft für klinische Spezialpr?parate mbH810
7Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized810
8Merck Sharp & Dohme LLC740
9Hunan Jiudian Pharmaceutical Co., Ltd651
10Beijing Tong Ren Tang Technology Development Co., Ltd. Pharmaceutical Factory romanized550

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

164 this week

AcceptedDrugApplicants
2025/12/25Import · Class 1 BCD-261注射液 · No verified English nameJXSL2500249 SPH-BIOCAD(HK)LIMITED; SPH-BIOCAD Biopharmaceuticals (SH) Co. Ltd.
2025/12/25Import · Class 2.2 MK-3475A注射液 · No verified English nameJXSL2500248 Merck Sharp & Dohme B.V.; MSD R&D (China) Co. Ltd
2025/12/25Import · Class 2.2 MK-3475A注射液 · No verified English nameJXSL2500247 Merck Sharp & Dohme B.V.; MSD R&D (China) Co. Ltd
2025/12/25Import · Class 2.2 伊奈利珠单抗注射液 · No verified English nameJXSL2500246 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2025/12/25Import · Class 1 MK-1084片 · No verified English nameJXHL2500395 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd
2025/12/25Import · Class 1 MK-1084片 · No verified English nameJXHL2500394 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd
2025/12/25Import · Class 1 Zorevunersen注射液 · No verified English nameJXHL2500393 Stoke Therapeutics Inc.; IQVIA RDS (Shanghai) Co. Ltd.
2025/12/25Import · Class 1 Zorevunersen注射液 · No verified English nameJXHL2500392 Stoke Therapeutics Inc.; IQVIA RDS (Shanghai) Co. Ltd.
2025/12/25Generic · Class 3 Venlafaxine Hydrochloride Extended Release TabletsCYHS2504406 TIANJIN LISHENG PHARMACEUTICAL CO., LTD
2025/12/25Generic · Class 3 Pazufloxacin Mesylate InjectionCYHS2504399 Hunan Jin Jian Pharma Co., Ltd. romanized
2025/12/25Generic · Class 3 Pazufloxacin Mesylate InjectionCYHS2504398 Hunan Jin Jian Pharma Co., Ltd. romanized
2025/12/25Generic · Class 3 Mesalazine Sustained-release GranulesCYHS2504391 Hunan Jiudian Pharmaceutical Co., Ltd
2025/12/25Generic · Class 3 Benazepril Hydrochloride and Hydrochlorothiazide TabletsCYHS2504390 Anhui Jia He Pharma Co., Ltd. romanized
2025/12/25Generic · Class 3 Multiple Electrolytes and Sodium Acetate InjectionCYHS2504389 Hai Tao Xin Yao Research and Development (Jiangsu) Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized
2025/12/25Generic · Class 3 Doxycycline Hyclate TabletsCYHS2504388 Zhejiang Yi Han Pharmaceutical Co., Ltd. romanized
2025/12/25Generic · Class 3 左羟丙哌嗪口服溶液 · No verified English nameCYHS2504387 Huayi Pharmaceuticals (Anhui) Co., Ltd.
2025/12/25Generic · Class 3 Pyridostigmine Bromide TabletsCYHS2504383 Sichuan Ke Rui De Pharmaceutical Co., Ltd. romanized
2025/12/25Generic · Class 3 Emedastine Difumarate Sustained-release CapsulesCYHS2504381 Mu Yuan (Anhui) Pharma Co., Ltd. romanized; Hua Yi Tai Kang Pharma Co., Ltd. romanized
2025/12/25Generic · Class 3 Emedastine Difumarate Sustained-release CapsulesCYHS2504379 Mu Yuan (Anhui) Pharma Co., Ltd. romanized; Hua Yi Tai Kang Pharma Co., Ltd. romanized
2025/12/25New drug · Class 1 SKB575(HBM7575)注射液 · No verified English nameCXSL2501137 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized; He Bo Pharmaceuticals (Shanghai) Co., Ltd. romanized
2025/12/25New drug · Class 1 注射用SG1827 · No verified English nameCXSL2501133 Hangzhou Shang Jian Bio Technology Co., Ltd. romanized
2025/12/25New drug · Class 1.2 LVRNA015 · No verified English nameCXSL2501132 Zhuhai Li Fan Da Bio Technology Co., Ltd. romanized
2025/12/25New drug · Class 1 注射用BG-C477 · No verified English nameCXSL2501131 Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized
2025/12/25New drug · Class 1 HLX3901注射液 · No verified English nameCXSL2501130 Shanghai Fu Hong Rui Lin Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceuticals Co., Ltd. romanized
2025/12/25New drug · Class 1 LYW2402-NS-HK人源基质细胞注射液(三维工艺制备) · No verified English nameCXSL2501129 Liaoning Yi Xue Zhen Liao Technology Research and Development Center Co., Ltd. romanized
2025/12/25New drug · Class 2.4 注射用BAT1006 · No verified English nameCXSL2501128 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2025/12/25New drug · Class 1 注射用BAT8008 · No verified English nameCXSL2501127 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2025/12/25New drug · Class 1 ICG366 CAR-T细胞注射液 · No verified English nameCXSL2501126 Song He Mian Yi Bio Medical (Shenzhen) Co., Ltd. romanized
2025/12/25New drug · Class 1 QBR202眼内注射液 · No verified English nameCXSL2501125 Xun Ji Bio Technology (Beijing) Co., Ltd. romanized
2025/12/25New drug · Class 1 QBR202眼内注射液 · No verified English nameCXSL2501124 Xun Ji Bio Technology (Beijing) Co., Ltd. romanized

134 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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