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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 321 drug applications between 19 November 2025 and 25 November 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 72, covering 60 drug names.

2025/11/19 – 2025/11/25

Period
2025/11/19 to 2025/11/25, 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
321
Drugs with new generic filings (by drug name, de-duplicated)
60
Accepted this week, now under review
83

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

321filings, 72 of them generic

By application type

Application typeFilings
Supplement145
Generic72
New drug60
Unspecified18
Import13
Import re-registration13

By drug type

Drug typeFilings
Chemical drug172
TCM85
Therapeutic biologic49
Biologic11
Prophylactic biologic4

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

60 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Lisdexamfetamine Dimesylate capsules414
2Sacubitril Valsartan Sodium Tablets3270
3氧(液态) · No verified English name2213
4Folic Acid Tablets2112
5Tolvaptan Orally Disintegrating Tablets215
6Sildenafil Citrate Tablets2112
7氯雷他定糖浆 · No verified English name217
8Loxoprofen Sodium Patches2130
9Glycerol Fructose And Sodium Chloride Injection213
10中性腹膜透析液(碳酸氢盐-G2.5%) · No verified English name117

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

206 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Qinghai Jiu Mei Cang Pharmaceuticals Technology Co., Ltd. romanized880
2Qilu Pharmaceutical Co., Ltd.872
3Jin Yao Da Ren Tang Group Co., Ltd. Le Ren Tang Pharmaceutical Factory romanized650
4Novartis Pharma AG540
5Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized510
6Guangdong Zhong Sheng Rui Chuang Bio Technology Co., Ltd. romanized510
7Topfond Pharmaceutical Co., Ltd.440
8Sichuan Shu Zhong Pharma Co., Ltd. romanized430
9Terumo Corporation Kofu Factory410
10Yi Chang Ren Fu Pharma Co., Ltd. romanized414

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

94 this week

AcceptedDrugApplicants
2025/11/25Import · Class 1 注射用Abelacimab · No verified English nameJXSL2500227 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2025/11/25Import · Class 1 PIT565 · No verified English nameJXSL2500226 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2025/11/25Import · Class 1 E6742 · No verified English nameJXHL2500363 Eisai Co. Ltd.; Eisai China Inc.
2025/11/25Generic · Class 3 Phenylephrine Hydrochloride InjectionCYHS2504063 Xu Bi Di Pharma (Cang Zhou) Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanized
2025/11/25Generic · Class 3 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2504056 Wuhan Yi Bo Yuan Pharmaceuticals Technology Co., Ltd. romanized; Chi Feng Yuan Sheng Pharma Co., Ltd. romanized
2025/11/25Generic · Class 3 Colchicine TabletsCYHS2504054 Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized
2025/11/25Generic · Class 3 Glycopyrronium Bromide and Neostigmine Metilsulfate InjectionCYHS2504051 Shang Yao Dong Ying (Jiangsu) Pharma Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2025/11/25New drug · Class 1.1 清瘟止咳颗粒 · No verified English nameCXZL2500119 Jiangxi Bao Zhong Pharmaceutical Co., Ltd. romanized
2025/11/25New drug · Class 2.3 女珍颗粒 · No verified English nameCXZL2500118 Shandong Feng Huang Pharmaceutical Co., Ltd. romanized
2025/11/25New drug · Class 1 注射用ASKG915 · No verified English nameCXSL2501005 Jiangsu Ao Sai Kang Biopharmaceuticals Co., Ltd. romanized
2025/11/25New drug · Class 2.2 重组人血小板生成素注射液 · No verified English nameCXSL2501004 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized
2025/11/25New drug · Class 2.2 重组人血小板生成素注射液 · No verified English nameCXSL2501003 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized
2025/11/25New drug · Class 1 GKL-006注射液 · No verified English nameCXSL2501002 Beijing Ji Yin Qi Ming Bio Technology Co., Ltd. romanized
2025/11/25New drug · Class 1 VC005片 · No verified English nameCXHL2501293 Jiangsu Wei Kai Er Pharmaceuticals Technology Co., Ltd. romanized
2025/11/25New drug · Class 1 ABSK-011胶囊 · No verified English nameCXHL2501292 Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized
2025/11/25New drug · Class 1 ABSK-011胶囊 · No verified English nameCXHL2501291 Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized
2025/11/25New drug · Class 1 ABSK-011胶囊 · No verified English nameCXHL2501290 Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized
2025/11/24Import · Class 1 注射用IPN10200 · No verified English nameJXSL2500225 Ipsen Innovation; Ipsen (Shanghai) Innovation Pharmaceutical Co. Ltd
2025/11/24Generic · Class 3 中性腹膜透析液(碳酸氢盐-G2.5%) · No verified English nameCYHS2504045 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2025/11/24Generic · Class 3 Folic Acid TabletsCYHS2504044 Beijing Foyou Pharma CO.,LTD
2025/11/24Generic · Class 3 Folic Acid TabletsCYHS2504043 Beijing Foyou Pharma CO.,LTD
2025/11/24New drug · Class 1 EP-0210单抗注射液 · No verified English nameCXSL2501001 Chengdu You Luo Bio Technology Co., Ltd. romanized
2025/11/24New drug · Class 1 R01注射液 · No verified English nameCXSL2501000 Hangzhou Niu An Jin Bio Technology Co., Ltd. romanized
2025/11/22Import · Class 1 Itepekimab注射液 · No verified English nameJXSL2500224 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2025/11/22Import · Class 1 Omecamtiv Mecarbil缓释片 · No verified English nameJXHL2500362 Cytokinetics Incorporated; PPD Pharmaceutical Development (Beijing) Co. Ltd
2025/11/22Import · Class 1 Omecamtiv Mecarbil缓释片 · No verified English nameJXHL2500361 Cytokinetics Incorporated; PPD Pharmaceutical Development (Beijing) Co. Ltd
2025/11/22Import · Class 1 Omecamtiv Mecarbil缓释片 · No verified English nameJXHL2500360 Cytokinetics, Incorporated; PPD Pharmaceutical Development (Beijing) Co. Ltd
2025/11/22Generic · Class 3 Dexketoprofen Trometamol InjectionCYHS2504037 Shandong Da Guan Pharmaceuticals Technology Co., Ltd. romanized; Shandong Hui Cheng Pharma Co., Ltd. romanized
2025/11/22Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2504035 Guangdong Nan Guo Pharma Co., Ltd. romanized
2025/11/22New drug · Class 3.4 注射用重组人凝血因子Ⅷ · No verified English nameCXSS2500125 Yuan Da Shu Yang Sheng Ming Ke Xue (Chengdu) Co., Ltd. romanized; Nanjing Peng Bo Bio Technology Co., Ltd. romanized

64 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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