YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 110 drug applications between 28 December 2020 and 3 January 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 10, covering 9 drug names.
2020/12/28 – 2021/01/03
The daily national snapshot started on 2026/10/22; the earlier days of this week have no complete acceptance-list snapshot yet, so this week's counts may be lower than the national total.
- New acceptances this week
- 110
- Drugs with new generic filings (by drug name, de-duplicated)
- 9
- Accepted this week, now under review
- 0
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
110filings, 10 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 70 |
| Unspecified | 14 |
| New drug | 13 |
| Generic | 10 |
| Import | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 85 |
| Therapeutic biologic | 19 |
| Prophylactic biologic | 3 |
| TCM | 2 |
| 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
9 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Ropivacaine hydrochloride injection | 2 | 1 | 5 |
| 2 | Emtricitabine and tenofovir disoproxil fumarate tablets | 1 | 1 | 0 |
| 3 | Torsemide Injection | 1 | 1 | 1 |
| 4 | Sodium Hyaluronate Eye Drops | 1 | 1 | 30 |
| 5 | Ambroxol Hydrochloride Injection | 1 | 1 | 9 |
| 6 | Moxifloxacin Hydrochloride And Sodium Chloride Injection | 1 | 1 | 10 |
| 7 | Rocuronium Bromide Injection | 1 | 1 | 1 |
| 8 | Sugammadex Sodium Injection | 1 | 1 | 6 |
| 9 | Apixaban 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
63 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Bard Pharmaceuticals Ltd. | 11 | 8 | 0 |
| 2 | F. Hoffmann-La Roche Ltd | 8 | 1 | 0 |
| 3 | Novartis Pharma Schweiz AG | 6 | 2 | 0 |
| 4 | Merck Sharp & Dohme Limited | 4 | 2 | 0 |
| 5 | Bristol-Myers Squibb Pharma EEIG | 4 | 1 | 0 |
| 6 | Jiangsu Huai An Shuang He Pharma Co., Ltd. romanized | 4 | 1 | 0 |
| 7 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 3 | 3 | 0 |
| 8 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc. | 3 | 2 | 0 |
| 9 | Pfizer Inc. | 3 | 1 | 0 |
| 10 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 2 | 2 | 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
16 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/01/01Import · Class 1 | PM1016注射液 · No verified English nameJXSL2000238 | TILT Biotherapeutics Ltd. |
| 2021/01/01Import · Class 2.2 | DS-8201a · No verified English nameJXSL2000237 | Daiichi Sankyo Inc. |
| 2021/01/01Generic · Class 3 | Torsemide InjectionCYHS2000959 | Yang Zi Jiang Pharma Group Nanjing Hai Ling Pharma Co., Ltd. romanized; Yangtze River Pharmaceutical Group Co., Ltd |
| 2021/01/01New drug · Class 1.1 | 坤怡宁颗粒 · No verified English nameCXZS2000010 | Tian Shi Li Pharmaceuticals Group Co., Ltd. romanized |
| 2021/01/01New drug · Class 1.1 | 安心颗粒 · No verified English nameCXZL2000025 | Suzhou Yu Sen Xin Yao Kai Fa Co., Ltd. romanized |
| 2021/01/01New drug · Class 1 | SGN1 · No verified English nameCXSL2000388 | Guangzhou Hua Jin Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/01/01New drug · Class 1 | BC006单抗注射液 · No verified English nameCXSL2000387 | Bao Chuan Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2021/01/01New drug · Class 1 | CM326注射液 · No verified English nameCXSL2000384 | Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized |
| 2021/01/01New drug · Class 1 | 重组人源化抗表皮生长因子受体单克隆抗体注射液 · No verified English nameCXSL2000379 | Shanghai Jin Man Te Bio Technology Co., Ltd. romanized |
| 2021/01/01New drug · Class 1 | SYHX1901片 · No verified English nameCXHL2000679 | CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2021/01/01New drug · Class 1 | SYHX1901片 · No verified English nameCXHL2000678 | CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2021/01/01New drug · Class 1 | LM-061片 · No verified English nameCXHL2000677 | Shanghai Li Xin Pharmaceuticals Research and Development Co., Ltd. romanized |
| 2021/01/01New drug · Class 1 | LM-061片 · No verified English nameCXHL2000676 | Shanghai Li Xin Pharmaceuticals Research and Development Co., Ltd. romanized |
| 2021/01/01New drug · Class 1 | 注射用CX13-608 · No verified English nameCXHL2000675 | Ningbo Sheng Jian Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/01/01New drug · Class 2.2; 2.4 | 醋酸阿比特龙片(I) · No verified English nameCXHL2000674 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/01/01New drug · Class 2.4 | 氟唑帕利胶囊 · No verified English nameCXHL2000673 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
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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