YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 349 drug applications between 9 September 2026 and 15 September 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 49, covering 38 drug names.

2026/09/09 – 2026/09/15

Period
2026/09/09 to 2026/09/15, 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
349
Drugs with new generic filings (by drug name, de-duplicated)
38
Accepted this week, now under review
302

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

349filings, 49 of them generic

By application type

Application typeFilings
Supplement200
New drug77
Generic49
Import15
Unspecified4
Import re-registration4

By drug type

Drug typeFilings
Chemical drug161
TCM114
Therapeutic biologic67
Prophylactic biologic5
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

38 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1盐酸金刚烷胺口服溶液 · No verified English name313
2Polidocanol Injection3123
3Indacaterol Maleate and Glycopyrronium Bromide Powder for Inhalation223
4Vonoprazan Fumarate Tablets2160
5Nilotinib Capsules216
6Ambroxol Hydrochloride Oral Solution2146
7Ziprasidone Hydrochloride Capsules219
8Oseltamivir Phosphate Capsules2139
9Sulindac Tablets215
10Acetylcysteine Oral Solution1111

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

222 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shaanxi Hua Xi Pharmaceutical Co., Ltd. romanized990
2Bo Hui Biopharmaceutical (Yunnan) Co., Ltd. romanized650
3Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized630
4F. Hoffmann-La Roche Ltd610
5Shenzhen Han Yu Pharma Co., Ltd. romanized610
6Shanxi Tian Sheng Pharmaceutical Co., Ltd. romanized550
7Jiangxi Hua Tai Pharma Co., Ltd. romanized550
8Shaanxi Ou Ke Pharma Co., Ltd. romanized550
9Beijing Zhi Tai Biopharmaceuticals Technology Co., Ltd. romanized510
10Tong Hua Bai Xin Pharma Co., Ltd. romanized440

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

106 this week

AcceptedDrugApplicants
2026/09/15Import · Class 1 RO7795068注射液 · No verified English nameJXHL2600408 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/09/15Import · Class 1 RO7795068注射液 · No verified English nameJXHL2600407 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/09/15Import · Class 1 RO7795068注射液 · No verified English nameJXHL2600406 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/09/15Import · Class 1 RO7795068注射液 · No verified English nameJXHL2600405 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/09/15Import · Class 1 RO7795068注射液 · No verified English nameJXHL2600404 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/09/15Import · Class 1 RO7795068注射液 · No verified English nameJXHL2600403 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/09/15Import · Class 1 RZL-012注射液 · No verified English nameJXHL2600402 Raziel Therapeutics (RT) Ltd.; Tianjin Juvestar Biotech Co. Ltd.
2026/09/15Generic · Class 3 盐酸金刚烷胺口服溶液 · No verified English nameCYHS2602291 Anhui Xin Shi Ji Pharma Co., Ltd. romanized
2026/09/15Generic · Class 3 盐酸金刚烷胺口服溶液 · No verified English nameCYHS2602290 Anhui Xin Shi Ji Pharma Co., Ltd. romanized
2026/09/15Generic · Class 3 盐酸金刚烷胺口服溶液 · No verified English nameCYHS2602289 Anhui Xin Shi Ji Pharma Co., Ltd. romanized
2026/09/15Generic · Class 3 Sevelamer Carbonate Powder for oral suspensionCYHS2602288 Zhuhai Jian Fu Pharmaceutical Co., Ltd. romanized
2026/09/15Generic · Class 3 Folic Acid TabletsCYHS2602286 Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized
2026/09/15Generic · Class 3 Sulindac TabletsCYHS2602279 Jiangsu Vanguard Pharmaceutical Co., Ltd.
2026/09/15Generic · Class 3 Sulindac TabletsCYHS2602278 Jiangsu Vanguard Pharmaceutical Co., Ltd.
2026/09/15Generic · Class 3 Acetylcysteine Oral SolutionCYHS2602277 Zhejiang Qian Jin Pharma Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized
2026/09/15Generic · Class 3 盐酸舍曲林口服浓缩液 · No verified English nameCYHS2602274 Yuan Da Pharmaceuticals (Xian) Co., Ltd. romanized; Beijing Hua Jin Pharmaceutical Co., Ltd. romanized
2026/09/15New drug · Class 1 3SC002注射液(皮下注射) · No verified English nameCXSL2601007 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized
2026/09/15New drug · Class 1 3SC002注射液 · No verified English nameCXSL2601006 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized
2026/09/15New drug · Class 1 KT502注射液 · No verified English nameCXSL2601004 Kai Lin Biopharmaceuticals (Shanghai) Co., Ltd. romanized
2026/09/15New drug · Class 1 IBI3009 · No verified English nameCXSL2601000 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2026/09/15New drug · Class 1 IBI3014 · No verified English nameCXSL2600998 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2026/09/15New drug · Class 1 注射用JS203 · No verified English nameCXSL2600997 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2026/09/15New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2600996 Hua Sai Ling Hang (Beijing) Bio Technology Co., Ltd. romanized
2026/09/15New drug · Class 1 注射用美罗培南普纳巴坦 · No verified English nameCXHS2600134 Qi Lu An Ti Pharmaceutical Co., Ltd. romanized
2026/09/15New drug · Class 1 注射用美罗培南普纳巴坦 · No verified English nameCXHS2600133 Qi Lu An Ti Pharmaceutical Co., Ltd. romanized
2026/09/15New drug · Class 2.2 BCM347 · No verified English nameCXHS2600132 Bo Zhi Yan Xin Tai Zhou Drug Technology Co., Ltd. romanized
2026/09/15New drug · Class 2.2 维生素K1注射用乳剂 · No verified English nameCXHS2600131 Xian An Jian Pharma Co., Ltd. romanized
2026/09/15New drug · Class 1 马来酸依格美妥司他片 · No verified English nameCXHS2600130 Suzhou Xin Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized; Yao Yuan Bio Technology (Qi Dong) Co., Ltd. romanized
2026/09/15New drug · Class 2.2 MEI-011泡沫剂 · No verified English nameCXHL2601130 Nanjing Mai Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized
2026/09/15New drug · Class 2.2 MEI-011泡沫剂 · No verified English nameCXHL2601129 Nanjing Mai Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized

76 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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