YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 345 drug applications between 1 March 2025 and 7 March 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 76, covering 57 drug names.
2025/03/01 – 2025/03/07
- New acceptances this week
- 345
- Drugs with new generic filings (by drug name, de-duplicated)
- 57
- Accepted this week, now under review
- 8
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
345filings, 76 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 183 |
| Generic | 76 |
| New drug | 53 |
| Import re-registration | 14 |
| Import | 13 |
| Unspecified | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 239 |
| TCM | 56 |
| Therapeutic biologic | 44 |
| Prophylactic biologic | 5 |
| 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
57 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Polidocanol Injection | 5 | 2 | 23 |
| 2 | Brexpiprazole Tablets | 3 | 1 | 31 |
| 3 | Loxoprofen Sodium Oral Solution | 2 | 2 | 6 |
| 4 | Mupirocin Ointment | 2 | 2 | 30 |
| 5 | Acetylcysteine Granules | 2 | 1 | 4 |
| 6 | Ibrutinib Tablets | 2 | 1 | 0 |
| 7 | Levetiracetam Tablets | 2 | 1 | 6 |
| 8 | Baricitinib Tablets | 2 | 1 | 32 |
| 9 | Famotidine Injection | 2 | 1 | 8 |
| 10 | 盐酸丙卡特罗吸入溶液 · No verified English name | 2 | 1 | 3 |
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
201 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Heilongjiang Shen Xing Biopharmaceuticals Technology Co., Ltd. romanized | 11 | 11 | 0 |
| 2 | Heilongjiang Lin Hai Xue Yuan Pharma Co., Ltd. romanized | 9 | 9 | 0 |
| 3 | Bayer AG | 8 | 1 | 0 |
| 4 | Shanghai Min Wei Bio Technology Co., Ltd. romanized | 8 | 1 | 0 |
| 5 | Merck Sharp & Dohme B.V. | 7 | 5 | 0 |
| 6 | Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 7 | Pfizer Inc. | 5 | 3 | 0 |
| 8 | Novo Nordisk A/S | 5 | 1 | 0 |
| 9 | Nanjing San Die Ji Pharmaceuticals Technology Co., Ltd. romanized | 5 | 1 | 0 |
| 10 | Guangdong Zhong Sheng Rui Chuang Bio Technology Co., Ltd. romanized | 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
101 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/03/07Generic · Class 3 | Memantine Hydrochloride OD TabletsCYHS2500954 | Hefei En Rui Te Pharma Co., Ltd. romanized |
| 2025/03/07Generic · Class 3 | Memantine Hydrochloride OD TabletsCYHS2500953 | Hefei En Rui Te Pharma Co., Ltd. romanized |
| 2025/03/07Generic · Class 3 | Pyridostigmine Bromide TabletsCYHS2500951 | Jilin Sheng Bo Da Wei Ye Pharmaceutical Co., Ltd. romanized |
| 2025/03/07New drug · Class 1 | SH006注射液 · No verified English nameCXSL2500211 | Nanjing Sheng He Pharma Co., Ltd. romanized |
| 2025/03/07New drug · Class 1 | BPR-102胶囊 · No verified English nameCXSL2500210 | Chengdu Bei Te Yi Kang En Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/03/07New drug · Class 1 | BPR-102胶囊 · No verified English nameCXSL2500209 | Chengdu Bei Te Yi Kang En Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/03/07New drug · Class 1.2 | LVRNA015 · No verified English nameCXSL2500208 | Zhuhai Li Fan Da Bio Technology Co., Ltd. romanized |
| 2025/03/07New drug · Class 1 | SHR-4712注射液 · No verified English nameCXSL2500207 | Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized; Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/03/07New drug · Class 1 | SHR-4712注射液 · No verified English nameCXSL2500206 | Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized; Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/03/07New drug · Class 1 | 注射用CS2009 · No verified English nameCXSL2500205 | Shen Shi Biopharmaceuticals (Shanghai) Co., Ltd. romanized; Ji Shi Pharma (Suzhou) Co., Ltd. romanized |
| 2025/03/07New drug · Class 1 | PRT-064040鼻喷雾剂 · No verified English nameCXHL2500257 | Sichuan Pu Rui Te Pharma Co., Ltd. romanized |
| 2025/03/07New drug · Class 1 | PRT-064040鼻喷雾剂 · No verified English nameCXHL2500256 | Sichuan Pu Rui Te Pharma Co., Ltd. romanized |
| 2025/03/07New drug · Class 1 | PRT-064040鼻喷雾剂 · No verified English nameCXHL2500255 | Sichuan Pu Rui Te Pharma Co., Ltd. romanized |
| 2025/03/07New drug · Class 1 | TRD205片 · No verified English nameCXHL2500254 | Beijing Tai De Pharmaceutical Co., Ltd. romanized |
| 2025/03/07New drug · Class 1 | TRD205片 · No verified English nameCXHL2500253 | Beijing Tai De Pharmaceutical Co., Ltd. romanized |
| 2025/03/07New drug · Class 2.2 | KEM2418缓释直服颗粒 · No verified English nameCXHL2500252 | Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized |
| 2025/03/06Import · Class 2.2 | 古塞奇尤单抗注射液 · No verified English nameJXSS2500022 | Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd. |
| 2025/03/06Import · Class 1 | PF-07275315注射液 · No verified English nameJXSL2500035 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2025/03/06Import · Class 1 | BI 1291583 片 · No verified English nameJXHL2500035 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2025/03/06Generic · Class 3 | Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2500941 | Hebei Tian Cheng Pharma Co., Ltd. romanized |
| 2025/03/06Generic · Class 3 | Bromhexine Hydrochloride Oral SolutionCYHS2500940 | Beijing SL Pharmaceutical Co., Ltd. |
| 2025/03/06Generic · Class 3 | 维生素B6注射液 · No verified English nameCYHS2500939 | Hui Yu Yuan He (Hainan) Pharma Co., Ltd. romanized; Hubei Jin Yao Pharma Co., Ltd. romanized |
| 2025/03/06Generic · Class 3 | Loxoprofen Sodium Oral SolutionCYHS2500933 | Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized; Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized |
| 2025/03/06Generic · Class 3 | 咪达唑仑鼻喷雾剂 · No verified English nameCYHL2500057 | Sichuan Pu Rui Te Pharma Co., Ltd. romanized |
| 2025/03/06Generic · Class 3 | Irbesartan and Amlodipine TabletsCYHL2500056 | Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/03/06New drug · Class 1 | 注射用维贝柯妥塔单抗 · No verified English nameCXSS2500034 | Le Pu Bio Technology Co., Ltd. romanized; Dong Yao Pharma Co., Ltd. romanized |
| 2025/03/06New drug · Class 1 | IMM27M注射液 · No verified English nameCXSL2500204 | Yi Ming Ang Ke Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2025/03/06New drug · Class 1 | TQB2930注射液 · No verified English nameCXSL2500203 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2025/03/06New drug · Class 1 | TQB2930注射液 · No verified English nameCXSL2500202 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2025/03/06New drug · Class 1 | CM336注射液 · No verified English nameCXSL2500201 | Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized |
71 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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