YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 287 drug applications between 6 January 2021 and 12 January 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 46, covering 37 drug names.
2021/01/06 – 2021/01/12
- New acceptances this week
- 287
- Drugs with new generic filings (by drug name, de-duplicated)
- 37
- Accepted this week, now under review
- 2
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
287filings, 46 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 168 |
| Generic | 46 |
| New drug | 42 |
| Import | 28 |
| Unspecified | 2 |
| Import re-registration | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 195 |
| Therapeutic biologic | 75 |
| TCM | 11 |
| Prophylactic biologic | 6 |
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
37 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Pregabalin Capsules | 3 | 1 | 12 |
| 2 | Pramipexole Dihydrochloride Prolonged-release Tablets | 3 | 1 | 0 |
| 3 | Voriconazole for Injection | 2 | 2 | 5 |
| 4 | Ipratropium Bromide Inhalation Solution | 2 | 1 | 2 |
| 5 | Ornidazole Injection | 2 | 1 | 0 |
| 6 | Piperacillin Sodium And Tazobactam Sodium For Injection | 2 | 1 | 5 |
| 7 | Pemetrexed Disodium for Injection | 2 | 1 | 4 |
| 8 | Metformin Hydrochloride and Vildagliptin Tablets | 1 | 1 | 0 |
| 9 | Tadalafil Tablets | 1 | 1 | 23 |
| 10 | Rivaroxaban Tablets | 1 | 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
167 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | BIOTON S.A. | 7 | 3 | 0 |
| 2 | Qilu Pharmaceutical Co., Ltd. | 6 | 5 | 5 |
| 3 | CSPC OUYI PHARMACEUTICAL CO., LTD. | 6 | 4 | 4 |
| 4 | Novartis Pharma Schweiz AG | 6 | 3 | 0 |
| 5 | Hua Lan Bio Gong Cheng Co., Ltd. romanized | 6 | 1 | 0 |
| 6 | Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized | 6 | 1 | 0 |
| 7 | YaoPharma Co., Ltd. | 5 | 3 | 1 |
| 8 | AstraZeneca AB | 5 | 2 | 0 |
| 9 | Changchun Jin Sai Pharma Co., Ltd. romanized | 5 | 1 | 0 |
| 10 | Hua Run Shuang He Li Min Pharma (Jinan) 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
68 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/01/12Import · Class 1 | VB4-845注射液 · No verified English nameJXSL2100006 | Sesen Bio Inc. |
| 2021/01/12Import · Class 1 | SHR8008胶囊 · No verified English nameJXHL2100013 | eVENUS PHARMACEUTICAL LABORATORIES INC. |
| 2021/01/11Generic · Class 3 | Oseltamivir Phosphate For Oral SuspensionCYHS2100038 | Suzhou Erye Pharmaceutical Co., Ltd |
| 2021/01/11Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2100033 | Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized |
| 2021/01/11Generic · Class 3 | Salbutamol Sulfate injectionCYHS2100032 | Chengdu Brilliant Pharmaceutical Co., Ltd. |
| 2021/01/11Generic · Class 3 | Lansoprazole For InjectionCYHS2100030 | Hunan Heng Sheng Pharmaceutical Co., Ltd. romanized |
| 2021/01/11New drug · Class 1 | YP01001胶囊 · No verified English nameCXHL2100016 | YaoPharma Co., Ltd. |
| 2021/01/11New drug · Class 1 | YP01001胶囊 · No verified English nameCXHL2100015 | YaoPharma Co., Ltd. |
| 2021/01/11New drug · Class 1 | YP01001胶囊 · No verified English nameCXHL2100014 | YaoPharma Co., Ltd. |
| 2021/01/11New drug · Class 1 | 50561片 · No verified English nameCXHL2000687 | Beijing Zhuo Kai Bio Technology Co., Ltd. romanized |
| 2021/01/11New drug · Class 1 | 50561片 · No verified English nameCXHL2000686 | Beijing Zhuo Kai Bio Technology Co., Ltd. romanized |
| 2021/01/09Import · Class 1 | Relatlimab/Nivolumab固定剂量复方注射液 · No verified English nameJXSL2100005 | Bristol-Myers Squibb Company |
| 2021/01/09Import · Class 2.4 | 阿贝西利片 · No verified English nameJXHL2100011 | Eli Lilly and Company |
| 2021/01/09Import · Class 2.4 | Macitentan TabletsJXHL2100010 | Actelion Pharmaceuticals Ltd |
| 2021/01/09Import · Class 2.4 | Macitentan TabletsJXHL2100009 | Actelion Pharmaceuticals Ltd |
| 2021/01/09Import · Class 1 | PF-06882961片 · No verified English nameJXHL2100008 | Pfizer Inc. |
| 2021/01/09Import · Class 1 | PF-06882961片 · No verified English nameJXHL2100007 | Pfizer Inc. |
| 2021/01/09Import · Class 1 | PF-06882961片 · No verified English nameJXHL2100006 | Pfizer Inc. |
| 2021/01/09Generic · Class 3 | 阿瑞匹坦注射液 · No verified English nameCYHS2100023 | Qilu Pharmaceutical Co., Ltd. |
| 2021/01/09New drug · Class 3.2 | 注射用重组人生长激素 · No verified English nameCXSS2100006 | Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized |
| 2021/01/09New drug · Class 3.2 | 注射用重组人生长激素 · No verified English nameCXSS2100005 | Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized |
| 2021/01/09New drug · Class 3.2 | 注射用重组人生长激素 · No verified English nameCXSS2100004 | Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized |
| 2021/01/09New drug · Class 3.2 | 注射用重组人生长激素 · No verified English nameCXSS2100003 | Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized |
| 2021/01/09New drug · Class 3.2 | 注射用重组人生长激素 · No verified English nameCXSS2100002 | Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized |
| 2021/01/09New drug · Class 3.2 | 注射用重组人生长激素 · No verified English nameCXSS2100001 | Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized |
| 2021/01/09New drug · Class 1 | 注射用QLS31901 · No verified English nameCXSL2100012 | Qilu Pharmaceutical Co., Ltd. |
| 2021/01/09New drug · Class 1 | MCLA-129注射液 · No verified English nameCXSL2100011 | Bei Da Pharma Co., Ltd. romanized |
| 2021/01/09New drug · Class 1 | SMR7694注射液 · No verified English nameCXSL2100010 | Wei Ming Biopharmaceuticals Co., Ltd. romanized |
| 2021/01/09New drug · Class 1 | 重组人源化抗IL-17A单克隆抗体注射液 · No verified English nameCXSL2100009 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/01/09New drug · Class 2.2 | 重组人血管内皮抑制素注射液 · No verified English nameCXSL2100008 | Shandong Xian Sheng Biopharmaceutical Co., Ltd. romanized |
38 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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