YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 488 drug applications between 20 September 2026 and 26 September 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 77, covering 60 drug names.
2026/09/20 – 2026/09/26
- New acceptances this week
- 488
- Drugs with new generic filings (by drug name, de-duplicated)
- 60
- Accepted this week, now under review
- 401
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
488filings, 77 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 267 |
| Generic | 77 |
| New drug | 73 |
| Import | 38 |
| Import re-registration | 19 |
| Unspecified | 14 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 257 |
| TCM | 135 |
| Therapeutic biologic | 87 |
| Biologic | 7 |
| Prophylactic biologic | 2 |
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
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 盐酸西替利嗪滴眼液 · No verified English name | 3 | 3 | 3 |
| 2 | Ertugliflozin Tablets | 3 | 3 | 13 |
| 3 | Baricitinib Tablets | 3 | 2 | 32 |
| 4 | Brimonidine Tartrate Eye Drops | 2 | 2 | 4 |
| 5 | Sildenafil Citrate Tablets | 2 | 1 | 12 |
| 6 | Tranexamic Acid Tablets | 2 | 1 | 9 |
| 7 | Sacubitril Valsartan Sodium Tablets | 2 | 1 | 70 |
| 8 | Nafamostat Mesilate for Injection | 2 | 1 | 38 |
| 9 | Sodium Hyaluronate Eye Drops | 2 | 1 | 30 |
| 10 | Metoprolol Succinate Extended-release Capsules | 2 | 1 | 4 |
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
302 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Janssen-Cilag International NV | 10 | 3 | 0 |
| 2 | Ji Chuan (Shanghai) Yi Xue Technology Co., Ltd. romanized | 9 | 2 | 0 |
| 3 | Bayer Vital GmbH | 9 | 1 | 0 |
| 4 | Beijing Kang Nuo Ya Biopharmaceuticals Co., Ltd. romanized | 8 | 1 | 0 |
| 5 | Shanxi Wang Long Pharma Group Co., Ltd. romanized | 6 | 5 | 0 |
| 6 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 6 | 1 | 0 |
| 7 | Xian Wan Long Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 8 | Jiangxi Pin Xin Pharma Co., Ltd. romanized | 5 | 2 | 0 |
| 9 | Boehringer Ingelheim International GmbH | 5 | 1 | 0 |
| 10 | Hubei Dong Xin Pharma Co., Ltd. romanized | 4 | 4 | 0 |
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
128 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/09/24Import · Class 1 | Duvakitug注射液 · No verified English nameJXSL2600260 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2026/09/24Import · Class 2.4 | Lenvatinib Mesilate CapsulesJXHS2600123 | Eisai Europe Limited; Eisai Co. Ltd. |
| 2026/09/24Import · Class 2.4 | Lenvatinib Mesilate CapsulesJXHS2600122 | Eisai Europe Limited; Eisai Co. Ltd. |
| 2026/09/24Import · Class 2.4 | 赛沃替尼片 · No verified English nameJXHL2600417 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/09/24Generic · Class 3 | Bilastine Oral SolutionCYHS2602414 | Anhui Tai Du Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd |
| 2026/09/24Generic · Class 3 | Dobutamine Hydrochloride InjectionCYHS2602413 | Shanxi Pu Heng Pharmaceutical Co., Ltd. romanized |
| 2026/09/24Generic · Class 3 | Ciclosporin Eye Drops(Ⅱ)CYHS2602410 | Jiangsu An Bi Sheng Pharmaceutical Co., Ltd. romanized |
| 2026/09/24Generic · Class 3 | 盐酸精氨酸注射液 · No verified English nameCYHS2602409 | Zhejiang Pharmaceuticals Co., Ltd. Xin Chang Pharmaceutical Factory romanized |
| 2026/09/24Generic · Class 3 | Nafamostat Mesilate for InjectionCYHS2602407 | Haikou Shi Pharmaceutical Factory Co., Ltd. romanized |
| 2026/09/24Generic · Class 3 | Nafamostat Mesilate for InjectionCYHS2602406 | Haikou Shi Pharmaceutical Factory Co., Ltd. romanized |
| 2026/09/24Generic · Class 3 | 辅酶Q??片 · No verified English nameThe loaded source record contains a question mark in this drug name; the original character has not been verified.CYHS2602404 | Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2026/09/24Generic · Class 3 | Peramivir InjectionCYHS2602403 | Hubei Zhang Lian Du Lei Pharmaceutical Co., Ltd. romanized |
| 2026/09/24Generic · Class 3 | 罂粟乙碘油注射液 · No verified English nameCYHL2600103 | Hainan Brilliant Pharmaceutical Co., Ltd. |
| 2026/09/24New drug · Class 1 | 注射用HS-20093 · No verified English nameCXSS2600155 | Changzhou Heng Bang Pharma Co., Ltd. romanized; Name not romanized |
| 2026/09/24New drug · Class 3.3 | 德谷胰岛素利拉鲁肽注射液 · No verified English nameCXSS2600154 | Zhuhai Lian Bang Biopharmaceuticals Co., Ltd. romanized; Zhuhai Lian Bang Pharmaceutical Co., Ltd. romanized |
| 2026/09/24New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSL2601064 | Guangzhou Bai Yun Shan Bai Di Biopharmaceuticals Co., Ltd. romanized; Nanjing Sai Nuo Biopharmaceutical Co., Ltd. romanized |
| 2026/09/24New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSL2601063 | Guangzhou Bai Yun Shan Bai Di Biopharmaceuticals Co., Ltd. romanized; Nanjing Sai Nuo Biopharmaceutical Co., Ltd. romanized |
| 2026/09/24New drug · Class 2.2 | 伏欣奇拜单抗注射液 · No verified English nameCXSL2601062 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2026/09/24New drug · Class 2.2 | 伏欣奇拜单抗注射液 · No verified English nameCXSL2601061 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2026/09/24New drug · Class 1 | C2403细胞注射液 · No verified English nameCXSL2601060 | Shenzhen Pu Rui Jin Bio Pharma Co., Ltd. romanized |
| 2026/09/24New drug · Class 1 | LVRNA018 · No verified English nameCXSL2601059 | Zhuhai Li Fan Da Bio Technology Co., Ltd. romanized |
| 2026/09/24New drug · Class 1 | LK101注射液 · No verified English nameCXSL2601058 | Beijing Li Kang Sheng Ming Technology Co., Ltd. romanized |
| 2026/09/24New drug · Class 1 | QM101细胞注射液(异体) · No verified English nameCXSL2601057 | Beijing Qi Mai Yong Hua Bio Technology Co., Ltd. romanized |
| 2026/09/24New drug · Class 1 | VV312片 · No verified English nameCXHL2601204 | Suzhou Wang Shan Wang Shui Biopharmaceuticals Co., Ltd. romanized; Zhongguo Ke College Shanghai Drug Research Institute romanized; Zhongguo Ke College Xinjiang Li Hua Technology Research Institute romanized |
| 2026/09/24New drug · Class 1 | VV312片 · No verified English nameCXHL2601203 | Suzhou Wang Shan Wang Shui Biopharmaceuticals Co., Ltd. romanized; Zhongguo Ke College Shanghai Drug Research Institute romanized; Zhongguo Ke College Xinjiang Li Hua Technology Research Institute romanized |
| 2026/09/24New drug · Class 1 | VV312片 · No verified English nameCXHL2601202 | Suzhou Wang Shan Wang Shui Biopharmaceuticals Co., Ltd. romanized; Zhongguo Ke College Shanghai Drug Research Institute romanized; Zhongguo Ke College Xinjiang Li Hua Technology Research Institute romanized |
| 2026/09/24New drug · Class 1 | 氟[18F]思睿肽注射液 · No verified English nameCXHL2601201 | Yan Tai Lan Na Cheng Bio Technology Co., Ltd. romanized |
| 2026/09/24New drug · Class 1 | LT-002-158片 · No verified English nameCXHL2601200 | Ling Tai Biopharmaceuticals (Shao Xing) Co., Ltd. romanized |
| 2026/09/23Import · Class 1 | Bimagrumab注射液 · No verified English nameJXSL2600259 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2026/09/23Import · Class 1 | Telisotuzumab Adizutecan 注射用粉末 · No verified English nameJXSL2600258 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd |
98 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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