YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 337 drug applications between 3 March 2026 and 9 March 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 23, covering 17 drug names.
2026/03/03 – 2026/03/09
- New acceptances this week
- 337
- Drugs with new generic filings (by drug name, de-duplicated)
- 17
- Accepted this week, now under review
- 75
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
337filings, 23 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 224 |
| New drug | 56 |
| Generic | 23 |
| Import | 23 |
| Import re-registration | 7 |
| Unspecified | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 152 |
| TCM | 110 |
| Therapeutic biologic | 68 |
| Prophylactic biologic | 6 |
| Biologic | 1 |
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
17 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Cetitizine Hydrochloride Oral Solution | 3 | 1 | 6 |
| 2 | 磷苯妥英钠注射用浓溶液 · No verified English name | 2 | 1 | 6 |
| 3 | Acetate And Glucose Electrolytes Injection | 2 | 1 | 4 |
| 4 | Gadoteridol Injection | 2 | 1 | 3 |
| 5 | Finerenone Tablets | 2 | 1 | 69 |
| 6 | Acetylcysteine Injection | 1 | 1 | 53 |
| 7 | Acetylcysteine Tablets | 1 | 1 | 8 |
| 8 | 二甲双胍恩格列净片(I) · No verified English name | 1 | 1 | 2 |
| 9 | 二甲双胍恩格列净片(VI) · No verified English name | 1 | 1 | 2 |
| 10 | 二甲双胍恩格列净片(V) · No verified English name | 1 | 1 | 1 |
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
178 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hong Ji Tang Pharmaceutical (Lai Wu Qu) Co., Ltd. romanized | 17 | 14 | 0 |
| 2 | Bayer Vital GmbH | 16 | 1 | 0 |
| 3 | Hubei Yi Ban Tian Pharmaceutical Co., Ltd. romanized | 9 | 2 | 0 |
| 4 | Eli Lilly and Company | 8 | 4 | 0 |
| 5 | Nei Menggu Ku Lun Meng Yao Co., Ltd. romanized | 6 | 6 | 0 |
| 6 | Tianjin Hong Ren Tang Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 7 | Amgen Inc. | 6 | 1 | 0 |
| 8 | Shanxi Huang He Zhong Yao Co., Ltd. romanized | 5 | 5 | 0 |
| 9 | Shaanxi Pan Long Pharma Group Co., Ltd. romanized | 5 | 5 | 0 |
| 10 | Novo Nordisk A/S | 5 | 1 | 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
90 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/03/09Generic · Class 3 | Gemcitabine Hydrochloride InjectionCYHS2600632 | Hefei Li Cheng Pharma Co., Ltd. romanized |
| 2026/03/09New drug · Class 2.1 | 特瑞普利单抗注射液(皮下注射) · No verified English nameCXSS2600038 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Jun Shi Bio Gong Cheng Co., Ltd. romanized |
| 2026/03/09New drug · Class 2.1 | 特瑞普利单抗注射液(皮下注射) · No verified English nameCXSS2600037 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Jun Shi Bio Gong Cheng Co., Ltd. romanized |
| 2026/03/09New drug · Class 2.1 | 特瑞普利单抗注射液(皮下注射) · No verified English nameCXSS2600036 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Jun Shi Bio Gong Cheng Co., Ltd. romanized |
| 2026/03/09New drug · Class 2.1 | 特瑞普利单抗注射液(皮下注射) · No verified English nameCXSS2600035 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Jun Shi Bio Gong Cheng Co., Ltd. romanized |
| 2026/03/09New drug · Class 1 | 熊去氧胆小檗碱胶囊 · No verified English nameCXHS2600040 | Shenzhen Jun Sheng Tai Bio Technology Co., Ltd. romanized; Wuxi He Quan Pharma Co., Ltd. romanized |
| 2026/03/07Generic · Class 3 | 磷苯妥英钠注射用浓溶液 · No verified English nameCYHS2600629 | Fu An Pharma Group Yan Tai Zhi Chu Pharma Co., Ltd. romanized |
| 2026/03/07Generic · Class 3 | 磷苯妥英钠注射用浓溶液 · No verified English nameCYHS2600628 | Fu An Pharma Group Yan Tai Zhi Chu Pharma Co., Ltd. romanized |
| 2026/03/07New drug · Class 2.2 | 冻干口服轮状减毒活疫苗(Vero细胞) · No verified English nameCXSL2600315 | Chengdu Mai Ke Kang Bio Technology Co., Ltd. romanized; Chengdu Hua Ren Kang Bio Technology Co., Ltd. romanized; Shanghai Mai Ke Kang Bio Technology Co., Ltd. romanized |
| 2026/03/07New drug · Class 1 | 注射用MK-1045 · No verified English nameCXSL2600314 | Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized |
| 2026/03/07New drug · Class 1 | GR1803注射液(皮下注射) · No verified English nameCXSL2600313 | Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized |
| 2026/03/07New drug · Class 1 | 注射用MK-1045 · No verified English nameCXSL2600312 | Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized |
| 2026/03/07New drug · Class 1.2 | 重组呼吸道合胞病毒疫苗(CHO细胞) · No verified English nameCXSL2600311 | Yi Kang Bio (Suzhou) Co., Ltd. romanized |
| 2026/03/07New drug · Class 1 | RLX-2505注射液 · No verified English nameCXSL2600310 | Suzhou Tuo Jie Pharmaceuticals Co., Ltd. romanized |
| 2026/03/07New drug · Class 1.2 | 重组呼吸道合胞病毒疫苗(CHO细胞)(佐剂) · No verified English nameCXSL2600309 | Yi Kang Bio (Suzhou) Co., Ltd. romanized |
| 2026/03/07New drug · Class 1 | SYH2095片 · No verified English nameCXHL2600281 | Hangzhou Ying Chuang Pharmaceuticals Technology Co., Ltd. romanized; Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized |
| 2026/03/07New drug · Class 1 | SYH2095片 · No verified English nameCXHL2600280 | Hangzhou Ying Chuang Pharmaceuticals Technology Co., Ltd. romanized; Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized |
| 2026/03/07New drug · Class 1 | HS-10541片 · No verified English nameCXHL2600279 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/03/07New drug · Class 1 | HS-10541片 · No verified English nameCXHL2600278 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/03/07New drug · Class 2.2 | BCM993 · No verified English nameCXHL2600277 | Shanghai Yun Cheng Yan Xin Bio Technology Co., Ltd. romanized |
| 2026/03/07New drug · Class 1 | D3S-003片 · No verified English nameCXHL2600276 | Name not romanized |
| 2026/03/06Import · Class 2.2 | 帕博利珠单抗注射液 · No verified English nameJXSS2600020 | MSD International Business GmbH; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd |
| 2026/03/06Import · Class 2.4 | 贝组替凡片 · No verified English nameJXHS2600030 | MERCK SHARP & DOHME (UK) LIMITED; MSD INTERNATIONAL GMBH; MSD R&D (China) Co. Ltd |
| 2026/03/06Generic · Class 3 | Acetylcysteine TabletsCYHS2600621 | Hebei Rui Sen Pharma Co., Ltd. romanized |
| 2026/03/06Generic · Class 3 | Cetitizine Hydrochloride Oral SolutionCYHS2600618 | Beijing Han Mei Bio Technology Co., Ltd. romanized; Beijing Han Mei Medicines Co., Ltd. romanized |
| 2026/03/06Generic · Class 3 | Cetitizine Hydrochloride Oral SolutionCYHS2600617 | Beijing Han Mei Bio Technology Co., Ltd. romanized; Beijing Han Mei Medicines Co., Ltd. romanized |
| 2026/03/06Generic · Class 3 | Cetitizine Hydrochloride Oral SolutionCYHS2600616 | Beijing Han Mei Bio Technology Co., Ltd. romanized; Beijing Han Mei Medicines Co., Ltd. romanized |
| 2026/03/06Generic · Class 3 | Acetate And Glucose Electrolytes InjectionCYHS2600615 | Chengdu Sai Nuo Lian Chuang Bio Technology Co., Ltd. romanized; Sichuan Tai Ping Yang Pharma Co., Ltd. romanized |
| 2026/03/06Generic · Class 3 | Acetate And Glucose Electrolytes InjectionCYHS2600614 | Chengdu Sai Nuo Lian Chuang Bio Technology Co., Ltd. romanized; Sichuan Tai Ping Yang Pharma Co., Ltd. romanized |
| 2026/03/06New drug · Class 1.1 | 小儿健脾消食颗粒 · No verified English nameCXZL2600026 | Shandong Han Fang Pharmaceutical Co., Ltd. romanized |
60 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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