YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 306 drug applications between 13 July 2022 and 19 July 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 51, covering 38 drug names.
2022/07/13 – 2022/07/19
- New acceptances this week
- 306
- Drugs with new generic filings (by drug name, de-duplicated)
- 38
- Accepted this week, now under review
- 3
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
306filings, 51 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 166 |
| Generic | 51 |
| Import | 40 |
| New drug | 34 |
| Import re-registration | 8 |
| Unspecified | 6 |
| Drug-device combination product | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 232 |
| TCM | 36 |
| Therapeutic biologic | 34 |
| Biologic | 2 |
| 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
38 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Palbociclib Capsules | 3 | 1 | 0 |
| 2 | Ruxolitinib Phosphate Tablets | 3 | 1 | 27 |
| 3 | Phloroglucinol Injection | 2 | 2 | 2 |
| 4 | Perampanel Tablets | 2 | 1 | 2 |
| 5 | 头孢丙烯干混悬剂 · No verified English name | 2 | 1 | 2 |
| 6 | Doxercalciferol Injection | 2 | 1 | 1 |
| 7 | Aminophylline Injection | 2 | 1 | 3 |
| 8 | Dexmedetomidine Hydrochloride Injection | 2 | 1 | 0 |
| 9 | Oxytocin Injection | 2 | 1 | 8 |
| 10 | Citicoline Sodium Injection | 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
167 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 13 | 4 | 3 |
| 2 | Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized | 10 | 10 | 0 |
| 3 | AstraZeneca AB | 8 | 4 | 0 |
| 4 | Shang Qiu Shi Jin Ma Pharma Co., Ltd. romanized | 7 | 7 | 0 |
| 5 | Sichuan Guo Rui Pharma Co., Ltd. romanized | 7 | 2 | 0 |
| 6 | Eli Lilly and Company | 6 | 1 | 0 |
| 7 | Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized | 6 | 1 | 0 |
| 8 | Qingdao Rui Nai Medical Technology Co., Ltd. romanized | 5 | 5 | 5 |
| 9 | Novartis Europharm Limited | 5 | 3 | 0 |
| 10 | Novartis Pharma AG | 5 | 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
101 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/07/19Import · Class 3.1 | 奥马珠单抗注射液 · No verified English nameJXSS2200025 | Novartis Europharm Limited; Vetter Pharma-Fertigung GmbH & Co. KG; Beijing Novartis Pharma Co. Ltd. |
| 2022/07/19Import · Class 3.1 | 安纳白介素注射液(预充式) · No verified English nameJXSS2200024 | Swedish Orphan Biovitrum AB (publ); Hospira Zagreb d.o.o.; SOBI Pharma (Shanghai) Company Limited |
| 2022/07/19Import · Class 2.2 | Efgartigimod注射液 · No verified English nameJXSL2200125 | argenx BV; Zai Lab (Shanghai) Co. Ltd. |
| 2022/07/19Import · Class 1 | RO7082859 · No verified English nameJXSL2200124 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2022/07/19Import · Class 1 | AZD5718片 · No verified English nameJXHL2200204 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd |
| 2022/07/19Import · Class 2.4 | Linzagolix片 · No verified English nameJXHL2200203 | Kissei Pharmaceutical Co. Ltd.; Bio Genuine (Shanghai) Biotech Co. Ltd. |
| 2022/07/19Import · Class 2.4 | Linzagolix片 · No verified English nameJXHL2200202 | Kissei Pharmaceutical Co. Ltd.; Bio Genuine (Shanghai) Biotech Co. Ltd. |
| 2022/07/19Generic · Class 3 | Citicoline Sodium InjectionCYHS2201104 | Hainan Quan Xing Pharmaceutical Co., Ltd. romanized |
| 2022/07/19Generic · Class 3 | Citicoline Sodium InjectionCYHS2201103 | Hainan Quan Xing Pharmaceutical Co., Ltd. romanized |
| 2022/07/19Generic · Class 3 | Butorphanol Tartrate InjectionCYHS2201102 | Chengdu Easton Biopharmaceuticals Co.,Ltd. |
| 2022/07/19Generic · Class 3 | Butorphanol Tartrate InjectionCYHS2201101 | Chengdu Easton Biopharmaceuticals Co.,Ltd. |
| 2022/07/19Generic · Class 3 | Ornidazole TabletsCYHS2201100 | Fu An Pharma Group Yan Tai Zhi Chu Pharma Co., Ltd. romanized |
| 2022/07/19Generic · Class 3 | 头孢丙烯干混悬剂 · No verified English nameCYHS2201099 | Suzhou Di San Pharmaceutical Factory Co., Ltd. romanized |
| 2022/07/19Generic · Class 3 | 头孢丙烯干混悬剂 · No verified English nameCYHS2201098 | Suzhou Di San Pharmaceutical Factory Co., Ltd. romanized |
| 2022/07/19New drug · Class 1.1 | 抗敏镇咳颗粒 · No verified English nameCXZL2200033 | Tianjin Le Dun Zhong Yao Co., Ltd. romanized |
| 2022/07/19New drug · Class 3.3 | 特立帕肽注射液 · No verified English nameCXSS2200068 | Shanghai Joint Sai Er Bio Gong Cheng Co., Ltd. romanized |
| 2022/07/19New drug · Class 1 | GC101腺相关病毒注射液 · No verified English nameCXSL2200324 | Beijing Jin Lan Ji Yin Technology Co., Ltd. romanized |
| 2022/07/19New drug · Class 2.4 | 注射用艾普拉唑钠 · No verified English nameCXHS2200040 | Li Zhu Group Li Zhu Pharmaceutical Factory romanized |
| 2022/07/19New drug · Class 2.4 | 奥雷巴替尼片 · No verified English nameCXHS2200039 | Guangzhou Shun Jian Biopharmaceuticals Technology Co., Ltd. romanized; Jiangsu Xuan Tai Pharma Co., Ltd. romanized |
| 2022/07/19New drug · Class 1 | LW402片 · No verified English nameCXHL2200516 | Shanghai Zhang Sen Pharma Co., Ltd. romanized |
| 2022/07/19New drug · Class 1 | LW402片 · No verified English nameCXHL2200515 | Shanghai Zhang Sen Pharma Co., Ltd. romanized |
| 2022/07/19New drug · Class 2.2; 2.4 | XYP-001 · No verified English nameCXHL2200508 | Health Yuan Pharma Group Co., Ltd. romanized |
| 2022/07/19New drug · Class 1 | LW402片 · No verified English nameCXHL2200492 | Shanghai Zhang Sen Pharma Co., Ltd. romanized |
| 2022/07/18Import · Class 3.1 | 依库珠单抗注射液 · No verified English nameJXSS2200023 | Alexion Europe SAS; Alexion Athlone Manufacturing Facility (AAMF); AstraZeneca Investment (China) Co. Ltd |
| 2022/07/18Import · Class 1 | Nolasiban分散片 · No verified English nameJXHL2200201 | ObsEva S.A.; Hangzhou Yuyuan Bioscience Technology Co. Ltd. |
| 2022/07/18Import · Class 1 | Nolasiban分散片 · No verified English nameJXHL2200200 | ObsEva S.A.; Hangzhou Yuyuan Bioscience Technology Co. Ltd. |
| 2022/07/18Generic · Class 3 | Magnesium Sulfate InjectionCYHS2201096 | Guangzhou Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2022/07/18Generic · Class 3 | Beraprost Sodium TabletsCYHS2201090 | Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized |
| 2022/07/18Generic · Class 3 | Dobutamine Hydrochloride InjectionCYHS2201088 | Chengdu Easton Biopharmaceuticals Co.,Ltd. |
| 2022/07/18Generic · Class 3 | Acotiamide Hydrochloride TabletsCYHS2201087 | Beijing Ya Bao Bio Pharma 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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